Comparison of effects of two changing position on severity of back pain, comfort, blood pressre, bleeding and hematoma after coronary angiography in Valiasre hospital of Qom, 2009
Background: Back pain and discomfort is frequently reported following coronary angiography (CC) due the prolonged bed rest after the procedure. Aim: The aim of this study was to compare the effect of 2 changing Positions on back pain, comfort, bleeding and hematoma after CC. Participants: A sample of 75 patients, who had undergone a non-emergency 6-French CC via the femoral artery from April to August, 2009. Exclusion criteria were: known bleeding disorders, experiencing back pain before the procedure, admission to the Coronary Care Unit after the procedure. Methods: In a single-blind randomized controlled trial, each patient was randomly divided into three equal groups. Patients in the first (control) group were managed as routine; they were restricted to a 6h bed rest in supine position with the affected leg straight and immobilized and a sand bag on the puncture site for at least 1h. The patients’ position in the second and third groups was intermittently changed during the first 6 h after angiography. The severity of back pain, level of comfort, amount of bleeding and hematoma were measured at regular intervals after the procedure.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138807182560N1
Registration date:2009-11-17, 1388/08/26
Registration timing:retrospective
Last update:
Update count:0
Registration date
2009-11-17, 1388/08/26
Registrant information
Name
Mohammad reza Yeganehkhah
Name of organization / entity
Qom University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 21 6630 4368
Email address
yeganehkhah@muq.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research of Qom University of Medical Sciences
Expected recruitment start date
2009-04-21, 1388/02/01
Expected recruitment end date
2009-08-22, 1388/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of effects of two changing position on severity of back pain, comfort, blood pressre, bleeding and hematoma after coronary angiography in Valiasre hospital of Qom, 2009
Public title
Comparison of effects of two positioning on back pain and comfort after coronary angiography
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: 1) Patients' ages between 18-80 years 2) Had undergone a non-emergency 6 French diagnostic angiography via the femoral artery 3) Had complete alert 4) Ability of patient to assess the pain & comfort with visual analogue scale 5) Had no active bleeding disorders 6) Had no chronic lower back pain
Exclusion criteria: 1) Had active bleeding at catheter insertion site after angiography 2) Development of artery disorders during angiography 3) Had systolic blood pressure greater than 190mmHg or diastolic blood pressure greater than110mmHg 4) Admission to the coronary care unit or intensive care unit 5) CPR during angiography 6) PT higher than 16 Sec 7) Had no pulse in feet 8) Inability of patient to help for changing 9) Had vomiting greater than 4 times during first 6 hours after angiography
Age
From 18 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
75
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Qom University of Medical Sciences and Health Services
Street address
Qom University of Medical Sciences and Health Services, Saheli st., Qom., Iran.
City
Qom
Postal code
37185
Approval date
2009-04-05, 1388/01/16
Ethics committee reference number
272/34/پ
Health conditions studied
1
Description of health condition studied
back pain and discomfort after coronary angiography
ICD-10 code
R29.0
ICD-10 code description
Acute pain
Primary outcomes
1
Description
reduced back pain and promote physical comfort without increasing vascular complications
Timepoint
every 2 hours(three time after coronary angiography) and next morning at 08:00h
Patients in the first (control) group were managed as routine
Category
N/A
2
Description
The patients in the second group were positioned as follows: in the supine position with the affected leg straight and immobilized and a sand bag on the puncture site for first hour, in the supine position with the affected leg straight and immobilized and head of bed [HOB]15° elevated during the second hour, in the supine position with the affected leg straight and immobilized and HOB 30° elevated during the third hour, in the supine position with the affected leg straight and immobilized and head of bed [HOB]45° elevated during the fourth hour, in the supine position with the affected leg straight and immobilized and head of bed [HOB]30° elevated during the fifth hour, in the supine position with the affected leg straight and immobilized and head of bed [HOB]15° elevated during the sixth hour. After that, the patients were allowed to come out of bed [OOB], to sit on the chair beside the bed for10min and then to walk around and undertake self care activities. In the second group, the sand bag was taken away 1h after the procedure.
Category
Treatment - Other
3
Description
The patients in the third group were positioned as follows: in the supine position with the affected leg straight and immobilized and a sand bag on the puncture site for first hour, in the semi right lateral position with the affected leg straight and immobilized during the second hour, in the supine position with the affected leg straight and immobilized during the third hour, in the semi left lateral position with the affected leg straight and immobilized during the second hour, in the supine position with the affected leg straight and immobilized during the fourth hour, in the semi right lateral position with the affected leg straight and immobilized during the fifth hour, in the supine position with the affected leg straight and immobilized during the sixth hour. While the patients in the third group were in semi lateral position, they were given a thin supportive pillow (10cm×40cm×70cm) under one side of their body, either left or right, from the shoulder to the gluteus area. We changed the place of the pillow every 1 hour in the right or the left side of the body. In seventh hour, the patients were allowed to come out of bed [OOB], to sit on the chair beside the bed for10min and then to walk around and undertake self care activities. In the third group, the sand bag was taken away 1h after the procedure.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
post ward angiography of Valiasre hospital of Qom
Full name of responsible person
Ali Honarman
Street address
City
Qom
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qom University of Medical Sciences and Health Services,
Full name of responsible person
Salimi, Ali
Street address
Qom University of Medical Sciences and Health Services, Saheli st., Qom., Iran
City
Qom
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qom University of Medical Sciences and Health Services,
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Qom University of Medical Sciences and Health Services