evaluate effect of changing position and early mobilization on back pain and vascular side effects in patients
Design
This experimental design are conduct on the 120 patients hospitalized for coronary angiography. Each Patient is assign randomly to either the control group(n= 60), which remain supine position 6 hours of bed rest after coronary angiography or experimental group(n= 60).
Settings and conduct
This clinical trial will be conducted in Tehran's Shahid Taleghani Hospital , in which the data analyzer will be blinded.
Participants/Inclusion and exclusion criteria
All subject of the research scheduled one day before for non emergency cardiac angiography via femoral artery. They are older than 18- years old with full conscious and ability for performing the project. The systolic blood pressure are not higher than 190 mmHg or diastolic higher than 110 mmHg. According to the patients data they should not have known bleeding disorders, peripheral vascular disease, experiencing back pain before the procedure, allergy to contrast materials
Intervention groups
control group will remain supine position 6 hours of bed rest after coronary angiography without changeling position.
The experimental group will remain 4 hours of bed rest after coronary , also is changed position hourly, varying between supine, elevated to 3o degrees and semi position (elevated to 45 degrees) during the first 4 hours after coronary angiography.
The vascular side effects were registered before and after angiography on immediate return to the ward, at first hour every 15 minutes and then hourly up to 6 hours and also in next morning after angiography. The back pain in both groups was assessed on immediate return to the ward and then after 2, 4 and 6 hours following cardiac angiography and the next morning.
Main outcome variables
intensity and extent back pain and vascular side effects
General information
Reason for update
Acronym
ندارد
IRCT registration information
IRCT registration number:IRCT20180723040562N1
Registration date:2019-05-21, 1398/02/31
Registration timing:retrospective
Last update:2019-05-21, 1398/02/31
Update count:0
Registration date
2019-05-21, 1398/02/31
Registrant information
Name
Neda Haghighi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5582 8977
Email address
neda.khoshkho@kiau.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2010-08-20, 1389/05/29
Expected recruitment end date
2012-10-21, 1391/07/30
Actual recruitment start date
2016-09-21, 1395/06/31
Actual recruitment end date
2018-06-09, 1397/03/19
Trial completion date
2018-06-09, 1397/03/19
Scientific title
Effect of changing position and early mobilization on back pain and vascular side effects in patients after coronary angiography
Public title
Effect of changing position and early mobilization on back pain and vascular side effects in patients after coronary angiography
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
scheduled one day before for non emergency cardiac angiography via femoral artery
older than 18- years old
The systolic blood pressure was not higher than 190 mmHg
The diastolic blood pressure was not higher than 110 mmHg
full conscious and ability for performing the project
The desire to participate in the study
not have known bleeding disorders, peripheral vascular disease, kideny disease ,experiencing back pain before the procedure, allergy to contrast materials
Having previous history of angiography
Exclusion criteria:
Having a back pain when you start a study
Desire to leave the study
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
120
Actual sample size reached:
120
Randomization (investigator's opinion)
Randomized
Randomization description
A randomized randomization was performed using a random number table.
Blinding (investigator's opinion)
Single blinded
Blinding description
The samples studied were blind about they are in the intervention or control group
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Faculty, Shaheed Beheshti University of Medical Sciences & Health Services
Street address
Faculty, Shaheed Beheshti University of Medical Sciences & Health Services, Velanjak
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2017-01-02, 1395/10/13
Ethics committee reference number
IR.SBMU.PHNM.1395.591
Health conditions studied
1
Description of health condition studied
back pain
ICD-10 code
M70
ICD-10 code description
Soft tissue disorders related to use, overuse and pressure
Primary outcomes
1
Description
score of NPS
Timepoint
Q 2 hours
Method of measurement
The back pain in both groups was assessed on immediate return to the ward and then after 2, 4 and 6 hours following cardiac angiography and the next morning.
Secondary outcomes
1
Description
vascular side effect
Timepoint
The vascular side effect were registered before and after angiography on immediate return to the ward, at first hour every 15 minutes and then hourly up to 6 hours and also in next morning after angiography
Method of measurement
Christenson's guidelines
Intervention groups
1
Description
Intervention group: remained 4 hours of bed rest after coronaryو also was changed position hourly, varying between supine, elevated to 3o degrees and semi position (elevated to 45 degrees) during the first 4 hours after coronary angiography.
Category
Prevention
2
Description
Control group: The control group received routine care after angiography, ie rest in the bed for 6 hours, resting in the back, and not changing the condition.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleghani hospital
Full name of responsible person
Masoumeh Neishabouri
Street address
Taleghani hospital, Erabi Ave, Velenjak, Tehran
City
Tehran
Province
Tehran
Postal code
230311 -021
Phone
+98 21 2303 1155
Email
taleghani@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Masoumeh Neishabouri
Street address
Shahid beheshti university of medical scienees. Erabi Ave, Velenjak. Tehran
City
Tehran
Province
Tehran
Postal code
+98 212388731
Phone
+98 21 2388 7311
Email
info@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Masoumeh Neishabouri
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Department of Nursing and Midwifery
City
Sari
Province
Mazandaran
Postal code
۳۳۹۷۱-۴۸۱۵۷
Phone
+98 33044000011
Email
mn.neishabouri@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Masoumeh Neishabouri
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nasibe Nursing and Midwifery Faculty
City
sari
Province
Mazandaran
Postal code
۳۳۹۷۱-۴۸۱۵۷
Phone
+98 33044000011
Email
mn.neishabouri@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Masoumeh Neishabouri
Position
associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nasibe Nursing and Midwifery Faculty
City
Sari
Province
Mazandaran
Postal code
۳۳۹۷۱-۴۸۱۵۷
Phone
+98 33044000011
Email
mn.neishabouri@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Some of the data, such as information on the main outcome or the like, can be shared.
When the data will become available and for how long
2019
To whom data/document is available
Researchers working in academic and academic institutions, students and medical science
Under which criteria data/document could be used
It is permissible to cite the results of research for scholars and researchers in the medical sciences department who are willing to continue working in the mentioned hospital.
From where data/document is obtainable
Masoumeh Neishabouri
mn.neishabouri@gmail.com
What processes are involved for a request to access data/document