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Discussion post 7

Specifically, address this critical element:

Conclusions. What does your evaluation of the strengths and weaknesses of the articles you selected suggest for future research in this field? Be sure to provide specific suggestions for potential next steps, based on evidence from your analysis, and explain how these suggestions would help improve decision making.

**See Articles attached**

PAGE 106 JOURNAL OF VASCULAR NURSING SEPTEMBER 2016
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Evaluation of feasibility and safety of
changing body position after transfemoral
angiography: A randomized clinical trial

Sina Valiee, PhD, Mohammad Fathi, PhD, Nooshin Hadizade, MD, Daem Roshani, PhD, and Parvin Mahmoodi, MS

From t
Kurdista
Nursing
Kurdista
Departm
Departm
Sanand
Univers

Corresp
Commit
Street, S

Funding
Kurdista
31229/1

1062-03

Copyrig

http://dx

Background: Considering the growing number of patients who suffer from cardiovascular and coronary artery disease

and the significant importance of angiography in the diagnosis of coronary artery disease, this study investigated the ef-

fects of position change on the acute complications of coronary angiography.

Methods: This study was a randomized clinical trial. Sixty patients undergoing coronary angiography, which was per-

formed by a single operator were selected by convenience sampling method and were assigned to intervention or control

groups by randomized block design (30 cases in each group). Intervention group patients’ position was changed according

to schedule, whereas patients in the control group remained in the supine position in complete bed rest. At the entrance

hours, 3, 6, 8, and 24 hours after the angiography, patients in both groups were evaluated in terms of vascular complica-

tions, urinary retention, low back pain, groin pain, and comfort. Data were analyzed by repeated measures, Friedman,

Mann–Whitney, chi-square, independent t-test, and Kolmogorov–Smirnov tests with SPSS-22.

Results: The two groups did not show any significant difference in terms of demographic, clinical, and preinterventional

catheterization characteristics (P > 0.05). There was no significant difference with regard to vascular complications

including hematoma (P = 0.149), bleeding (P > 0.01), bruise (P = 0.081), and thrombosis in the two groups of patients

during 5 consecutive reviews. However, there was a significant statistical difference regarding low back pain

(P < 0.001), groin pain (P < 0.001), urinary retention (P = 0.02), and comfort (P < 0.001).

Conclusions: The results of this study showed that changing the positions of patients after angiography based on the

provided program created no change in the incidence of vascular complications (hematoma, bleeding, thrombosis, and

bruise) but resulted in reduced severity of back pain, groin pain, urinary retention, and increased patients’ comfort. (J

Vasc Nurs 2016;34:106-115)

Cardiovascular disease is one of the leading causes of death
for women and men of all ethnicities and races,1 and it is ex-
pected to remain the most common cause of death in the world
until 2020.2 Among heart disease, coronary artery diseases is
the most common and life-threatening one.3

he Social Determinants of Health Research Center,
n University of Medical Sciences, Sanandaj, Iran;
Department, School of Nursing & Midwifery,

n University of Medical Sciences, Sanandaj, Iran;
ent of Epidemiology and Biostatistics, Medicine
ent, Kurdistan University of Medical Sciences,

aj, Iran; Student Research Committee, Kurdistan
ity of Medical Sciences, Sanandaj, Iran.

onding author: Parvin Mahmoodi, MS, Student Research
tee, Kurdistan University of Medical Sciences, Pasdaran
anandaj, Iran (E-mail: mahmoodi.parvin@muk.ac.ir).

: This work was supported by the Research Council of
n University of Medical Sciences (grant number 1035/
4).

03/$36.00

ht � 2016 by the Society for Vascular Nursing, Inc.

.doi.org/10.1016/j.jvn.2016.05.001

There are different diagnostic methods for assessing coronary
artery disease.4 Coronary angiography is the golden standard test
to identify the presence and extent of atherosclerotic disease of
coronary artery.5 Annually, nearly three million cardiac catheter-
izations are done in the United States of America.6 Angiography
involves injecting a radiopaque dye into the coronary arteries un-
der fluoroscopy which determines the condition of the coronary
arteries and the degree of atherosclerosis.

Although the risks and complications associated with angiog-
raphy depends on the patient’s condition, operator’s skill, and
judgment, any invasive procedure has some complications asso-
ciated with the procedure.5 Coronary angiography can be ac-
cessed via the potential arteries included brachial, radial and
femoral arteries.7–11 About 95% of angiography is performed
via femoral artery.12,13

Access to the heart via femoral artery can be accompanied with
complications such as arrhythmia, vascular complications
(bleeding, hematoma, and thrombosis), injury and myocardial
ischemia, coronaryartery perforation, hemodynamic collapse, cer-
ebrovertebral accident including transient ischemic attack, allergy
to contrast media and acute renal failure.14–18 Demonstration of
these complications can be divided in two main form of acute
and chronic. The former includes hematoma, bleeding,
thrombosis, urinary retention, low back pain, and groin pain.5

Studies have shown that to avoid possible complications due
to arterial injuries, the current method of treatment after

Delta:1_given name

Delta:1_surname

Delta:1_given name

Delta:1_surname

Delta:1_given name

mailto:mahmoodi.parvin@muk.ac.ir

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angiography in many health care facilities in Iran is to have the
patient rest in the supine position with the head angle of zero de-
grees for 8–24 hours and keeping 4 kg (8.82 lbs) sandbag on the
catheter insertion site for 6 hours,19–21 which has often been
conducted based on tradition and experience.19 This insistence
on bed rest for patients after coronary catheterization can lead
to restlessness, discomfort, and frequent complaint of back and
groin pain.

11
About 42% of patients who get out of bed after

4 hours of rest experience back pain.24 In addition, 11.4% of pa-
tients undergoing this procedure may develop urinary reten-
tion.14,25 Back pain, groin pain, and urinary retention leads to
the use of analgesic medications and urinary catheterization
which are associated with their own specific complications. To
avoid complications resulting from the use of analgesic
medications and urinary catheterization, nonmedical measures
and nursing care are appropriate.10

Development of technology along with procedures requires
appropriate medical and nursing care.

22,23
Although there is

much evidence for medical approach to care, little evidence
exists to support the suggestions relating to management areas
such as patient’s position, the time of getting out of bed, and
the time of removing sandbag which are generally related to
the nursing activities territory.9,24-26 A recent literature review
showed that caring of patients undergoing cardiac
catheterization requires a revision in key areas of nursing
care.19,22,25 Abdollahi et al14 (2013) reported that in addition to
changes in body position and leaving the bed early, no vascular
complications in patients undergoing coronary angiography
was seen, whereas urinary retention in the control group was
observed. Rezaei-Adaryani et al

19
(2009) reported that patients

whose positions were switched during the period of bed rest
had experiences less fatigue but more comfort and satisfaction
in the 3, 6, 8, and 24 hours after arrival to the postangiography
ward. In addition, changes in body position had no significant
impact on increased bleeding and hematoma compared with
the control group.19 Heravi et al27 (2013) comparing the patients
in supine positions with the head angle of 0, 15, 30, 45, and 60 in
separate groups reported that patients with head angle of 45� had
experienced the lowest pain, so it was declared as the best
position.

One of the nursing measures is changing the position of the
patient who has undergone transfemoral angiography during
bed rest, but it is avoided due to the fear of the vascular
complications.

The effects of position change in patients after transfemoral
angiography during bed rest will be evaluated as it relates to
vascular complications. This study aimed to determine the ef-
fect of changing position on urinary retention, back pain, pain
in the groin, and comfort of patients undergoing coronary
angiography.

METHOD

The study is a single-blind randomized clinical trial in two
groups which was approved by the Kurdistan University of
Medical Sciences research Council. The study’s proposal is
registered at (www.irct.com) by the registration number
IRCT2015091424018N1.

Sample size and sampling

The samples were chosen by convenience sampling method,
and they were randomly allocated into control and intervention
groups. The sample size with 95% confidence interval and
80% statistical power was estimated 60 patients (30 patients in
the intervention group and 30 patients in the control group)
(Figure 1).

Participants

Participants were patients undergoing coronary angiography.
Inclusion criteria included nonemergency catheterization, age
18–65 years old, less than 180/100 mm Hg blood pressure,
absence of active bleeding disorders, prothrombin time (PT),
and partial thromboplastin time (PTT) of less than 16 and 90 sec-
onds, respectively, consent to participate in the study, angiog-
raphy via the femoral artery, no history of deep vein
thrombosis (DVT) before the procedure, not being treated with
thrombolytic (not taking streptokinase) and anticoagulant drugs
(not taking warfarin), no history of diabetes with sensory prob-
lems, not taking any analgesic medications before the procedure,
not suffering from peripheral arterial disease, no history of uri-
nary problems, no history of allergy to contrast media, no depen-
dency to drugs, lack of chronic low back pain, absence of blood
and liver diseases. Exclusion criteria included needle entrance
more than once to access the artery, cardiopulmonary resuscita-
tion during angiography, movement disability, and disorder in
the level of consciousness in a way that the patient can not coop-
erate to change position and incomplete termination of clinical
intervention period.

Ethical considerations

This study was approved by the Research Council of Kurdi-
stan University of Medical Sciences with the contract number
1035/31229/14 and was confirmed for ethical considerations by
receiving the moral code muk.rec.1394.194 from the ethics com-
mittee of Kurdistan University. While explaining the purpose and
method of study for the patients, informed consent was obtained
from them.

Measuring tool

The instrument used to collect and record information in this
was a three-part questionnaire which was designed according to
the study.

The first part was demographic and clinical information form
which contained information about age, height, weight, gender,
marital status, education, occupation, history of smoking, dia-
betes, history of previous coronary angiography, systolic and dia-
stolic blood pressure, body mass index, PT, PTT, international
normalized ratio, and platelet count which was recorded based
on the information contained in patients’ medical records.

Patients’ blood pressure was measured and recorded by one
person using a mercury sphygmomanometer (ALP K2 model:
no 300-VS; Tanaka Sangyo Co, Ltd, Tokyo, Japan) which was
calibrated before the start of the study. Their height and weight
were measured and recorded by one person using digital scales
(Bermend BD7750) and centimeters. The second section con-
tained procedural information form which contained the length

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Assessed for eligibility (n = 81)

Excluded (n= 15):
• Chronic Low Back Pain(n = 6)
• unwillingness to participate in

the study(n = 4)
• history of taking

anticoagulant(n = 2)
• Dependence on opium (n = 3)

Randomized (n = 66)

Allocated to intervention group(n = 33):
• Received routine care (n = 33)
• Did not received routine care (n = 0)

A
llo

ca
ti

E
nr

ol
lm

en
t

Allocated to control group (n = 33)
• Received changing of body

position(n = 33)
• Did not receive allocated

intervention(n = 0)

F
ol

lo
w

u
p

Lost to follow up (n =3):

• Had anaphylactic reactions to the
contrast agent(n =2)

• Failure to did angiography because
of obstruction in abdominal aortic
(n =1)

Lost to follow up (n =3):
• Had chest pain and take analgesic

medications (n=2)
• 3 times needle inserted to acces

artery (n =1)

A
na

ly
si

Analyzed (n =30) Analyzed (n =30)

Figure 1. Consolidated Standards of Reporting Trials (CONSORT) flow diagram.

PAGE 108 JOURNAL OF VASCULAR NURSING SEPTEMBER 2016
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of angiography, homeostasis time, size of the catheter used,
injury of the femoral artery, and the type and volume of contrast
agent, diagnosis of coronary artery stenosis which were prepared
using a chronometer and the information contained in patient
records.

Part three of the evaluation form included angiographic com-
plications such as hematoma, bleeding, urinary retention, back
pain, groin pain, and comfort. Back pain, groin pain, and comfort
were measured and recorded with standard numeric rating
scale.28 Patients’ comfort level was measured by a general ques-
tion about the overall level of comfort at the time of measure-
ment. The patients were asked to rate their comfort from 0 to
10 grades. The validity of this scale was set by Johnson and
Carol.22 The reliability was estimated by Farrar et al and Good
et al to be 0.78 and 0.83.29,30 Hematoma shape and bruise was
placed on transparent paper and then on graph paper, and the
side of intended shape was measured and recorded (based on
the biggest length and width) per square centimeter. The
amount of bleeding was measured by weighing Gauze soaked
in blood by 0.1 gm sensitive Japanese scale (standard future).
Urinary retention was also analyzed based on patient interview.
All the measurements were carried out by the principal
researcher.

Intervention procedures

After the selection of eligible patients for inclusion into the
study and providing the necessary explanations, obtaining
informed consent, necessary data were obtained from medical re-
cords, and blood pressure was measured and recorded. The pa-
tients were randomly entered into to the intervention group.
After controlling patients’ vital signs and marking dorsal pedis
and posterior tibialis pulses on their feet, the patients were
entered in the angiography catheterization room. On completion
of angiography and exiting the catheterization laboratory, the
sheath was removed by cardiology nurses, mechanical or manual
homeostasis was applied on the insertion site until the blood
coagulated. The time hemostasis was measured by stopwatch,
and it procedural information was recorded based on the case.

After hemostasis, 2 folded 4 � 4 (4 cm length and width)
gauzes was put on the catheter site (the reason of making the
gauzes 2 folded was to expose the catheter insertion site to the
maximum extent possible for ease of evaluating complications).
Transparent bandage covered the dressing to check for the ease in
monitoring for hematoma and bleeding. Then, two 4 kg (8.82 lbs)
sandbags were placed on the site, and the second sandbag was
removed after stabilization of the patient. The patient came to
the postangiography ward with only one sandbag. After entering

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TABLE 1

PROTOCOLS OF BODY POSITION AND METHODS OF ANALYSIS IN THE GROUPS

Group 1st & 2nd hour 3rd & 4th hour 5th hour 6th hour 7th & 8th hour 9th hour 24th hour

Intervention
Group

Supine Supine, HOB Right side, HOB Left side, HOB Sitting position OOB OOB

45� El 15� El 15� El
Control group Supine Supine Supine Supine Supine OOB OOB

HOB = head of bed; EL = elevation.

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the control group patients to the postangiography ward routine,
cares were performed. The patient was immobile in the supine
position, with head angle of zero degree, 8 hours complete bed
rest, and 4 kg (8.2 lbs) sandbags was put on the site where the
catheter was inserted for 6 hours.

After entering the intervention group patients to the post
angiography ward, the patient had 8 hours complete bed rest,
4 kg sandbag was put on the site where the catheter was inserted
for 6 hours, but changing position was applied while taking rest
in the bed for 8 hours (Table 1). During the first and second hours,
the patient was kept in the supine position and the head angle of
zero degree. During the third and fourth hours, the patient was
kept in the supine position with the head angle of 45�. During
the fifth and sixth hours, the patient was lying on the left or right
side with the head angle of 15� and in the seventh and eighth hour
the patients were cared in the sitting position (Table 2). The third
part of the questionnaire was measured and recorded immedi-
ately after entering the ward, third, sixth, eighth, and 24th hours
later (before discharge from the ward; Table 2).

Statistics

After collecting data to assess the normal distribution of data,
Kolmogorov–Smirnov test was used. To compare the two inter-
vention and control groups in terms of demographic, clinical,
and procedural quality, chi-square and Fisher’s exact tests were
used. Moreover, to compare quantitative variables independent
t-test and Mann–Whitney tests were used.

RESULTS

Eighty-one patients were assessed for inclusion criteria.
Some patients were excluded from the study for the following
reasons including; three patients because of a history of chronic
low back pain, four patients because of an unwillingness to
participate in the study, two patients because of the history of
anticoagulant, and three patients due to taking opium. Thirty-
three patients were assigned to each group. During the study,
in the intervention group, two patients were excluded from the
study due to chest pain and taking analgesic and one patient
due to needle entrance to the arteries more than once. In the con-
trol group, two patients were excluded due to anaphylactic reac-
tions and one patient due to stenosis in the abdominal aorta.
Finally, two groups (n = 30, each group) were analyzed. There
was no significant difference between the two groups of

participants in terms of demographic and clinical data include
of mean age, height, weight, systolic blood pressure, diastolic
blood pressure, body mass index, PT, PTT, platelet count, inter-
national normalized ratio, homeostasis time length, contrast me-
dia volume, amount of smoking, marital status, education level,
smoking history, history of diabetes, history of previous coronary
angiography, rupture of the femoral artery, final diagnosis,
recommend treatment, and the amount of stenosis in the right
coronary, left main coronary, left circumflex arteries, and the
two groups were homogenous (Tables 3 and 4). But in terms of
gender, occupation, catheter size, type of contrast, the stenosis
of left anterior descending artery, and duration of angiography
were significantly different (Tables 3 and 4). The mean age of
the patients was 10.445 � 57.71, and 34 patients (56.66%)
were male and 58 (96.65%) were married.

The results showed that the incidence of hematoma between
the two groups was not significant. Moreover, hematoma in the
intervention group (P = 0.006) was significantly different at
different times, but in the control group (P = 0.149), the differ-
ence was not significant (Table 4).

Considering the P values in Table 5, to compare between
intervention and control groups at different times, there were
no significant differences between the intervention and control
groups in terms of hematoma (Table 5).

The results showed that the incidence of urinary retention in
the control group (P = 0.023) and intervention group (P = 0.020)
were significantly different at different times (Table 4). With re-
gard to the P values in Table 5, pairwise comparison between
intervention and control group at different times, there were no
significant differences between the intervention and control
groups in terms of complications of urinary retention (Table 4).

Furthermore, the incidence of thrombosis remained un-
changed at different times and was not observed in none of the
participants.

In addition, the incidence of bleeding was significantly
different in terms of time (P $ 0.001). The test results of Bonfer-
roni procedure showed that in the control group at third, eighth,
and 24th hours were not significantly different in terms of the
mean of this variable and in the intervention group there was a
significant difference only between the time of entrance and
the other times.

The results showed that the incidence of bruise between the
two groups in different measurements did not differ significantly
in terms of time (P = 0.081).

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TABLE 2

DISTRIBUTION OF UNITS IN TERMS OF VARIABLES

Variable Group Mean � SD P value

Age* Control 56.56 � 9.15 0.401
Intervention 58.86 � 11.74

Heighty Control 164.16 � 11.31 0.151
Intervention 166.16 � 12.58

Weight* Control 74.88 � 21.67 0.52
Intervention 77.43 � 22.64

The number of cigarettes smoked per
dayy

Control 8.1 � 4.1 0.076
Intervention 9.15 � 56.56

No. of previous angiographyy Control 0.66 � 0.33 0.076
Intervention 16.36 � 0.1

Systolic blood pressurey Control 122.26 � 19.11 0.653
Intervention 123.33 � 14.93

Diastolic blood pressure
y

Control 74.03 � 11.58 0.583
Intervention 75.33 � 8.6

Volume of contrast dyey Control 51.33 � 23 0.564
Intervention 51.33 � 22.55

BMI
y

Control 55.99 � 36.64 0.6
Intervention 26.34 � 3.62

PTy Control 11.73 � 0.86 0.364
Intervention 11.56 � 0.93

PTT
y

Control 31.7 � 3.00 0.298
Intervention 33.1 � 6.7

Plt count* Control 245230 � 9.15 0.298
Intervention 250610 � 80.01

INRy Control 17 � 1.15 0.292
Intervention 1.14 � 0.28

Duration of hemostasis periody Control 7.95 � 3.69 0.603
Intervention 6.41 � 1.67

Duration of angiography periody Control 23.78 � 10.51 0.031
Intervention 245230 � 9.15

BMI = body mass index; INR = international normalize rate; PT = protrombin time; Plt count = platelet count; PTT = partial thromboplastin time.

*T independent.
yMann–Whitney.

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The results showed that the incidence of groin pain was
significantly different in terms of time (P > 0.001). The results
of Bonferroni for comparing sampling time between the inter-
vention and control groups showed that during the study period
except at zero and 24th hour the difference was significant in
terms of intended complication.

The results showed that the incidence of comfort (based on
numeric rating scale) had a significant difference in terms of
time in this complication (P = 0.001). Bonferroni procedure

for pairwise comparisons of the sampling time between the
intervention and control groups during the study period showed
a significant difference except for the time of admission and
24th hour. Moreover, there was a significant difference for the
incidence of back pain in terms of time. Bonferroni for pairwise
comparisons of the sampling time between the intervention and
control groups during the study period showed a significant dif-
ference in terms of comfort except for the time of entrance and
24th hour.

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TABLE 3

DISTRIBUTION OF SUBJECTS BASED ON QUALITATIVE VARIABLES BETWEEN THE TWO GROUPS OF
CONTROL AND INTERVENTION

Variable Subgroup Intervention Control P value

Gender** Male 22 12 0.009

Female 8 18

Marital status** Married 30 28 0.492

Single 0 1

Widow 0 1

Divorced 0 0

Education** Illiterate 22 18 0.445

Under diploma 7 9

Diploma 1 3

Academic 0 0

Job status** Clerk 2 1 0.002

Self-employed 19 6

Retired 3 4

Housewife 6 18

Unemployed 0 1

Smoking history* Has 17 8 0.018

Has not 13 22

Diabetes record* Has 7 9 0.559

Has not 23

Angiography
history**

Has 1 6 0.103

Has not 29 24

Catheter size** F400 1 0 0.006
F500 1 0
F600 20 29
F700 8 1

Rupture of the
femoral artery**

Has 0 0 1.00

Has not 30 30

Type of contrast
media**

Meglumine 14 20 0.019

Visipaque 16 7

Meglumine and
Visipaque

0 3

Disease diagnosis* NECA 10 16 0.425

1VD 2 2

2VD 12 7

3VD 6 5

Significance stenosis
of coronary
arteries

*RCA 9 7 0.559

**LMCA 1 0 1.00

*LAD 14 6 0.028

**LCX 4 8 0.333

(Continued)

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TABLE 3

CONTINUED

Variable Subgroup Intervention Control P value

Urinary
retention***

Has 9 10

Has not 21 20

F00 = French; NECA = normal epicardial coronary arteries; 1VD = one vessel disease; 2VD = two vessel disease; 3VD = three vessel disease; RCA = right
coronary artery; LMCA = left main coronary artery; LCX = left circumflex artery; LAD = left anterior descending.

Chi-square test**, Fisher exact test*, and Friedman test*.

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DISCUSSION

The findings of this study showed that changes in body posi-
tion after angiography did not create a change in the incidence of
vascular complications including hematoma, bleeding, throm-
bosis, and bruising compared to the control group, whereas uri-
nary retention was reduced. In addition, changing body
position reduced back pain, groin pain, and finally improved
the comfort of the patient.

Other studies finding agree with the results of this study and a
significant difference in the incidence of complications after cor-
onary angiography at the catheter insertion site between the inter-
vention and control groups was not reported. For example,

TABLE 4

RESULTS OF ACUTE COMPLICATIONS

Variable Group Hour 0 Hour 3rd

Hematoma* Control 1.07 � 3.23 1.07 � 3.23
Intervention 0.43 � 2.19 0.43 � 2.19

Urinary retention* Control 2 1.93 � 0.25
Intervention 1.93 � 0.25 2.56 � 3.68

Bruise
y

Control 1.08 � 3.37 1.1 � 3.37
Intervention 0.35 � 1.82 0.36 � 1.82

Bleeding
y

Control 0 0.01 � 0.07
Intervention 0 0.01 � 0.05

Back painy Control 2.74 � 2 3.1 � 4.46
Intervention 2.66 � 1.6 3.3 � 2.83

Groin painy Control 0.26 � 0.63 3.1 � 2.57
Intervention 0 1.03 � 2.04

Comforty Control 9.66 � 1.82 7.6 � 2.48
Intervention 10 9.06 � 1.7

Thrombosisy Control 0 0
Intervention 0 0

*Friedman test.
yRepeated measures test.

Abdollahi et al (2015) studied the simultaneous effects of early
ambulation (4 hours of bed rest) and changes in body position
with a different protocol from this study. The time points for
analyzing the patient in terms of complications were different.
In their study, no hemorrhage and hematoma was reported. It
was found that changes in body position in and early ambulation
after coronary interventions did not increase the vascular
complications.14

Furthermore, the results indicated that changes in body posi-
tion had no impact on the incidence of acute vascular complica-
tions, including hematoma and bleeding. Moreover, Yeganeh
Khah et al (2012) compared the effect of different ways of chang-
ing patients’ position on the vascular complications of after

Hour 6th Hour 8th Hour 24th Sig

0.61 � 1.78 0.31 � 0.97 0.08 � 0.43 0.006
0.33 � 1.64 0.1 � 0.40 0 0.149
1.83 � 0.37 1.76 � 0.43 1.8 � 0.4 0.023
1.8 � 0.4 1.7 � 0.46 1.9 � 0.25 0.02

1.03 � 3.18 0.8 � 2.54 0.12 � 0.45 0.081
0.16 � 0.73 0.026 � 0.14 0.026 � 0.14
2.3 � 12.77 0.16 � 0.54 4.38 � 7.56 0.001>

0.01 � 0.03 0.11 � 0.19 5.34 � 4.59
3.14 � 5.8 3.26 � 4.03 1.85 � 0.43 0.001>
3.14 � 2.3 2.75 � 1.56 0
4.86 � 3.08 3.7 � 2.74 2.36 � 2.20 0.001>
1.96 � 2.37 1.86 � 2.16 1.66 � 2.45
6.03 � 2.2 6.6 � 2.4 8.63 � 1.67 0.001>
8.5 � 2.2 7.9 � 2.39 8.9 � 2.15

0 0 0 0

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TABLE 5

MANN–WHITNEY TEST TO COMPARE THE
GROUPS TWO BY TWO IN TERMS OF STUDY
TIME

Variable Measurement time P value

Hematoma Entrance time 0.317

Third hour 0.579

Sixth hour 0.394

Eighth hour 0.222

24th hour 0.222

Urinary retention Entrance time 0.312

Third hour 0.563

Sixth hour 0.741

Eighth hour 0.977

24th hour 0.154

Vol. XXXIV No. 3 JOURNAL OF VASCULAR NURSING PAGE 113
www.jvascnurs.net

coronary angiography and reported that none of the patients
developed bleeding and arterial occlusive and no significant dif-
ference between intervention and control groups were observed
in changing body position.

Rezaei-Adaryani et al (2009) compared the effect of three
different body positions including the supine position, changing
the head angle and changing side by side in three separate groups
and found that changing body positions did not have an impact
on the amount of bleeding and hematoma of the two groups at
different times after angiography.19 This study was different
from Adaryani study because it was a comparative study con-
ducted on two groups, and different body positions were used,
but the findings were consistent with the Adaryani study. Acute
vascular complications after coronary angiography are hema-
toma, bleeding, and thrombosis.14–18

Farmanbar et al (2012) studied changes in body position and
duration of bed rest in two separate groups. Fisher’s exact test
showed no significant difference between the two groups. In
this study, patients had sandbags just for 2 hours and after 4 hours
changing position they got out of bed. Three patients in the con-
trol group and one patient in the experimental group had hema-
toma. One case of bleeding in the control group and one in the
intervention group were reported as well.

31
However, in this

study, the effect of changing position was studied not only on
the complications but also on back pain, groin pain, urinary
retention, and comfort, and the rate of incidence of complications
was lower. Nyshabouri and Ashke-e-torab (2007) studied the ef-
fect of changing the bed angles on the incidence of vascular com-
plications and reported no case of hematoma, bleeding, and
thrombosis among the groups.32 In this study after two hours
of rest in the supine position, the patient’s head angle was in
45� because in previous studies the lowest amount of complica-
tions was in this position. Therefore, changing body positions in
the bed based on the presented method had no effect on the

incidence of vascular complications such as hematoma, bleeding,
and thrombosis and did not make any complications in the pa-
tients. Based on several studies, movement limitations and com-
plete bed rest resulted in frequent complaint of low back pain.14

As a result patients request for analgesic and changing position
frequently to resolve the pain in the bed.19 Therefore, relieving
pain and providing patient comfort without increasing vascular
complications after coronary angiography is one of the nursing
goals.13

Yilmaz et al (2007) in Turkey studied the effect of sandbags
and changing the patient’s position on the incidence of vascular
complications, and they claimed that there was no difference be-
tween the groups of patients who had or had not sandbag on the
site of catheter insertion. However, the pain severity in the group
who had changing positions was by far less than the other group
which is consistent with the findings of our research. Moreover,
there was no significant difference between the two groups in the
second hour which was not in accordance with our findings

because in Yilmaz et al study the sandbag was on the site of cath-
eter insertion for two hours and a half, whereas in our study it was
6 hours.

To compare changes in bleeding, bruise, back pain, groin
pain, comfort, and thrombosis over time within groups repeated
measures test was used and if the difference was significant Bon-
ferroni test was used. To compare changes regarding hematoma
and urinary retention over time within groups Friedman test was
used, and for pairwise comparison of intervention and control
groups Mann–Whitney test was used based on distinct time of
study.

Back pain and urinary retention were observed as common
complication in looking after patients undergoing angiography.
Relying on noninvasive methods to empty the bladder is prefer-
able because bladder catheterization increases the risk of urinary
tract infection.22 Abdolahi et al (2015) in a study regarding
changing positions compared the control and experimental
groups with a different protocol from this study and found that
no significant differences exist between the two groups in terms
of complications of urinary retention14 which is consistent with
our study. Pairwise comparisons of sampling time showed that
there was significant difference in terms of the intended compli-
cation between intervention and control groups during the study
period except at zero and 24th hour which was probably due to
the reason that at the zero hour patients in both groups were in
supine position with head angle of zero degree and at 24th
hour both groups were out of bed and as a result due to the
equality of body position, it is expected that the difference did
not become significant.

Changing body position in the bed improves the patient’s
comfort.13 Many teams emphasizes on immobilitzation to avoid
bleeding, which can cause patient comfort Rezaei-Adaryani
et al

19
(2015) in a study regarding changing positions compared

the control and experimental groups with a different protocol
from this study and found that the intervention group had signif-
icantly more comfort at third, sixth, eighth hours, and the morn-
ing after angiography compared with the control group which
was consistent with our study.19 Change in body position based
on the proposed manner resulted in decrease in lower back
pain, groin pain, urinary retention, and increase in comfort.

http://dx.doi.org/10.1016/j.jvn.2016.05.001

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PAGE 114 JOURNAL OF VASCULAR NURSING SEPTEMBER 2016
www.jvascnurs.net

Limitations and suggestions for future research

It is recommended that in future studies analyze the impact of
early ambulation, the duration of keeping sandbag on the catheter
insertion and sandbags with different weights on the incidence of
acute and chronic complications at different time points from this
study, to improve care after coronary angiography.

CONCLUSIONS

The results of this study showed that changing position after
angiography based on the method provided, without change in
the incidence of vascular complications (hematoma, bleeding,
thrombosis, and bruise) reduced the severity of back pain, groin
pain, urinary retention, and improved patients’ comfort. By
changing position in bed after coronary angiography, nurses can
increase patients’ comfort. New nurses tend to be cautious and
the more seasoned nurses adhere to routine. Therefore, it is recom-
mended that cardiology and postangiography ward nurses, use the
position change based on the present study. Interventionalist and
nurse comfort play a role in patient comfort and reposition. Inter-
ventionalists will need to address any postprocedural complica-
tion for patients which may affect the level of their comfort. We
can reduce the complications including urinary retention, discom-
fortback and groin pains by positionchange. So by decreasing the-
ses complications, the interventionalists comfort will increase due
to lower discuses about postprocedural complications and their
high level of comfort affect patients comfort.

ACKNOWLEDGMENTS
Hereby, the authors want to appreciate the Deputy of
Research at Nursing and Midwifery faculty of Kurdistan Uni-
versity of Medical Sciences, angiography and cardiac ward’s
staff at Tohid Hospitals affiliated with Kurdistan University of
Medical Sciences and all those patients who have helped us in
this study. This study entitled the Comparative Study of the
Effects of Sand Bag Keeping Time and Changing Body Posi-
tion on Acute Complications of Coronary Angiography in
Referring Patients to the Sanandaj Tohid Hospital, 2015 is a
part of MS thesis of Parvin Mahmoodi which is approved in
Kurdistan University of Medical Sciences.

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Evaluation of feasibility and safety of changing body position after transfemoral angiography: A randomized clinical trial

Method
Sample size and sampling
Participants
Ethical considerations
Measuring tool
Intervention procedures
Statistics
Results
Discussion
Limitations and suggestions for future research
Conclusions
Acknowledgments
References

R E S E A R C H I N B R I E F

The effect of ambulation after cardiac catheterization on patient

outcomes

Sek Ying Chair MBA, PhD, RN

Assistant Professor, The Nethersole School of Nursing, The Chinese University of Hong Kong, Hong

Kong, China

David R Thompson PhD, MBA, RN, FRCN, FESC

Director and Professor of Clinical Nursing, The Nethersole School of Nursing, The Chinese University of Hong Kong, Hong

Kong, China

Shu Kin Li MBBS, FRCP

Chief of Service, Department of Medicine, Pamela Youde Nethersole Eastern Hospital, Hong Kong, China

Submitted for publication: 24 August 2005

Accepted for publication: 26 January 2006

Introduction

Cardiac catheterization remains the most definitive procedure

for diagnosis and evaluation of coronary artery disease

(Woods et al. 2005). Currently, cardiac catheterization has

become a routine diagnostic procedure performed in many

hospitals in Hong Kong. Although it can be performed

through brachial, radial, or femoral arteries (Woods et al.

2005), the transfemoral puncture is the most common

approach (Noto et al. 1991, Chair et al. 2003). However,

because vascular complications occur in 0Æ43–5Æ8% of

transfemoral cardiac catheterization patients (Noto et al.

1991, Lehmann et al. 1997, Chair et al. 2003), strict bed rest

and immobilization of the catheterized leg have been consid-

ered essential to reduce the risk of their development

(Grossman 1980, Woods et al. 2005). The recommended

bed rest duration after transfemoral cardiac catheterization

varies from two to 24 hours (Baum & Gantt 1996, Chair

et al. 2003). Many patients find it difficult to use the bedpan

or urinal in the recumbent position during bed rest, more-

over, studies reported that back pain severity increased with

longer duration of bed rest after cardiac catheterization

(Barkman & Lunse 1994, Baum & Gantt 1996, Chair et al.

2003). Therefore, to obtain optimal patient outcomes, the

length of bed rest duration after cardiac catheterization

should be minimized.

Aims

The aims of this study were to compare patient outcomes of

vascular complications, back pain, and urinary discomfort

between patients ambulated at four and 12–24 hours (usual

care) post-transfemoral cardiac catheterization.

Methods

Patients admitted for elective cardiac catheterization at a

general hospital in Hong Kong Island were recruited to the

study. Inclusion criteria were that patients should be ethnic

Chinese, aged over 18 years, had no bleeding disorders, were

not receiving anti-coagulant therapy within the previous

24 hours before the procedure, had no back pain, blood

pressure <180/110 mmHg before the procedure and no

complications developed during cardiac catheterization.

Patients were randomly assigned to either a control or

experimental group according to a computer-generated

random table of number. Patients in the experimental group

were ambulated after four hours bed rest postcardiac

catheterization, whereas patients in the control group were

ambulated the morning after the procedure, 12–24 hours

Correspondence: Sek Ying Chair, The Nethersole School of Nursing,

The Chinese University of Hong Kong, Shatin, New Territories,

Hong Kong, China. Tel: (852) 2609 6225, E-mail: sychair@cuhk.

edu.hk

� 2007 Blackwell Publishing Ltd
212 doi:10.1111/j.1365-2702.2006.01599.x

after bed rest depending on the time the patient had the

procedure completed during the day (usual care).

The puncture site was assessed for vascular complications

hourly for the first six hours then the next morning at

08:00 hours using the guidelines (Christenson et al. 1976).

Significant bleeding was defined as blood loss estimated at

>100 ml, haematoma >5 cm in width or bleeding that led to

further attempts to reestablish haemostasis by manual pres-

sure, sandbag, or reinforcement of pressure dressing. For all

patients, back pain was assessed at four hours, eight hours and

the next morning at 08:00 hours after cardiac catheterization

by using a visual analogue scale consisting of a 100-mm long

line with the left anchor representing ‘no pain’, and the right

anchor representing ‘the worst possible pain’. Urinary discom-

fort was assessed at six hours after the procedure by use of a

five-point Likert scale self-developed measurement consisting

of four questions, a higher value referring to more urinary

discomfort. The test–retest reliability of the urinary discomfort

measurement on 18 subjects was significantly correlated

(r ¼ 0Æ95, P < 0Æ001), and the Cronbach’s alpha was 0Æ876.

Findings

A total of 86 (male, n ¼ 41; female, n ¼ 45) subjects
completed the study, 43 in each group with a mean age of

63 years (SD ¼ 9Æ6, range 34–75). Fifty-six (65%) subjects
had either received no formal education or were educated at

elementary level, and eight (9Æ3%) had received a college

education. Most (65Æ1%) subjects had a monthly family

income

patients (82Æ6%) were either retired or housewives. Table 1

shows that the two groups were not significantly different in

age, gender, education level, and monthly household income.

Occupation status was significantly different between the two

groups (chi-square, P ¼ 0Æ009) with more retired subjects in
the control groups but more housewives in the experimental

group.

There was no difference between the two groups on vascular

complications. One subject in the control and none in the

experimental group developed bleeding at the puncture site

that required manual pressure to re-establish haemostasis

(Fisher’s exact test, P ¼ 1). Repeated measures analysis of
variance was used to evaluate the back pain experienced across

time and between groups. There was a significant difference

between the two groups at the three time intervals on back

pain intensity (F2,83 ¼ 9Æ80, P < 0Æ001) with the control group reporting more pain at each time interval. Moreover,

the two groups also differed significantly on urinary discom-

fort (t65Æ6 ¼ 3Æ24, P ¼ 0Æ006) with the control group experi-
encing higher levels of urinary discomfort (Table 1).

Table 1 Demographic and outcomes comparisons between groups

Control (n ¼ 43) Experimental (n ¼ 43) P-value Statistical test used

Age [years: mean (SD)] 63Æ2 (±9Æ7) 62Æ7 (±9Æ7) 0Æ816 t-Test
Gender, n (%)

Male 19 (44Æ2) 22 (51Æ2) 0Æ517 Chi-square
Female 24 (55Æ8) 21 (48Æ8)

Educational level, n (%)

No formal education 11 (25Æ6) 12 (17Æ9) 0Æ729 Mann–Whitney U-test
Primary school 16 (37Æ2) 17 (39Æ6)
Secondary school 13 (30Æ2) 9 (20Æ9)
University 3 (7) 5 (11Æ6)

Monthly household income, n (%)

£HK$8000 22 (51Æ2) 34 (79) 0Æ052 Mann–Whitney U-test
HK$8001–$18 000 14 (32Æ6) 6 (14)
>HK$18 001 7 (16Æ2) 3 (7)

Occupation, n (%)

Retired 30 (69Æ8) 21 (48Æ8) 0Æ009 Chi-square
Housewife 4 (9Æ3) 16 (37Æ2)
Presently working 9 (20Æ9) 6 (14)

Vascular complications, n (%) 1 (2Æ3) 0 (0) 1Æ00 Fisher’s exact test
Back pain

Four hours 1Æ55 0Æ97 <0Æ001 Repeated measure of ANOVAANOVA Eight hours 4Æ41 1Æ34 The next morning 4Æ01 1Æ77

Urinary discomfort 2Æ57 1Æ09 0Æ006 t-Test

Research in brief

� 2007 Blackwell Publishing Ltd, Journal of Clinical Nursing, 16, 212–214 213

Discussion

Prolonged bed rest in the supine position is difficult for many

patients who have undergone cardiac catheterization. Some

patients complain of back pain and have the desire to move

from side to side. Others complain of difficulty to urinate in a

supine position. In this study, patients allowed to ambulate at

four hours postcardiac catheterization experienced signifi-

cantly less back pain and less urinary discomfort, but did

not experience any increase in vascular complications at

puncture site.

The average age, high unemployment rate, low education

standard and low-income level of patients in this study was

reflective of the study site which is less affluent than the

general Hong Kong population

Implications for practice

The results suggests that early ambulation may play a

substantial role in reducing back pain and urinary discomfort

in post-transfemoral cardiac catheterization. Allowing pa-

tients to get out of bed after four hours of bed rest following

cardiac catheterization could be introduced into routine

practice in Hong Kong, as it was found to be safe and might

aid in promoting patient comfort without increasing the

incidence of vascular complications. In addition, the shorter

bed rest duration may reduce the nursing time needed for

administering analgesics or back rubs to relieve back pain.

Early ambulation after cardiac catheterization may also

reduce the nursing time needed for assisting patients to use

urinal and bedpan during bed rest period after the procedure.

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Research in brief

214 � 2007 Blackwell Publishing Ltd, Journal of Clinical Nursing, 16, 212–214

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