Determining the effect of bed angle change on back pain and urinary retention after coronary angiography
Design
A randomized clinical trial with two groups of test and control , with 120 subjects as sample size, a purpose-based sampling method and dividing subjects into two groups of test and control
Settings and conduct
This clinical trial study was conducted on 120 patients after cardiac angiography .In this study, patients after angiography were placed in two back positions with angle of 0 degrees and 30 degrees. They were compared for the severity of back pain and urinary retention.The location of the study was the Shahid Sadoghi hospital in Yazd city.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Patient's candidate for angiography, aged over 18 years. Perform angiography via femoral artery .Insert the needle only once .Use the Sheath number 6 and 7. Non-Inclusion criteria:Patients with back pain history and prostate hypertrophy.
Intervention groups
Patients in intervention group were placed in bed at 30 degree angle at the time of arrival and up to 4 hours later. Patients in control group: were placed in bed at zero degree angles at the time of arrival and up to 4 hours later.
Main outcome variables
Back pain; urinary retention
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181212041938N1
Registration date:2019-08-11, 1398/05/20
Registration timing:retrospective
Last update:2019-08-11, 1398/05/20
Update count:0
Registration date
2019-08-11, 1398/05/20
Registrant information
Name
Maasoumeh Barkhordari-Sharifabad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3821 0540
Email address
barkhordari_m@iauyazd.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-05, 1397/02/15
Expected recruitment end date
2018-09-06, 1397/06/15
Actual recruitment start date
2018-05-10, 1397/02/20
Actual recruitment end date
2018-10-12, 1397/07/20
Trial completion date
2018-10-12, 1397/07/20
Scientific title
The Effect of Bed Angle Change on Back Pain and Urinary Retention after Coronary Angiography
Public title
Effect of Bed Angle on Back Pain and Urinary Retention after Angiography
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient's candidate for angiography, aged over 18 years
Perform angiography via femoral artery
Insert the needle only once
Use the Sheath number 6 and 7
Exclusion criteria:
Patients with back pain history
Patients with prostate hypertrophy
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Actual sample size reached:
120
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization of this study is simple randomization. Randomization unit was individual. The samples were determined and assigned to two groups by random number table. Researcher closes our eyes and randomly point to a spot on the chart .the path in the random numbers table was from left to right. Even numbers considered for the intervention group and odd numbers for the control group. The sample size was 120.On average, 150 patients were admitted to the ward per month. The expected duration of study was 4 months. Therefore, the research population was 400 Patients candidate for angiography. The numbers were below 400 in the random number table. .If the number was odd; they would be in the intervention group and if the number was even; they would be in the control group. This was done until 60 individuals were selected for intervention group and 60 for the control group. It should be noted that if we encountered a duplicate number, that number would be deleted.Also a random extra list of 10 people was prepared for both groups. If one of the selected individuals did not meet the inclusion or exclusion criteria or was not willing to participate in the study, another subject replaced. The daily sampling was performed .From the first day of the study; patients were enrolled based on the number one referral for angiography. If the number is selected who had inclusion criteria and agreed to participate in the study, they were studied in the intervention or control group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Islamic Azad University - Isfahan (Khorasgan) Branch
Street address
Islamic Azad University Isfahan (Khorasgan) Branch., University Blvd., Jey St., Isfahan town
City
Isfahan
Province
Isfehan
Postal code
815513998
Approval date
2018-04-18, 1397/01/29
Ethics committee reference number
IR.IAU.KHUISF.REC.1397.083
Health conditions studied
1
Description of health condition studied
Cardiac catheterization
ICD-10 code
Y84.0
ICD-10 code description
Cardiac catheterization
Primary outcomes
1
Description
Back pain
Timepoint
Measurement of pain intensity immediately and four hours after angiography
Method of measurement
Numerical Visual Scale of Pain
2
Description
Urinary Retention
Timepoint
Measurement of urinary retention immediately and tow hours after angiography
Method of measurement
According to the patient's statements
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients were placed in bed at 30 degree angle at the time of arrival and up to 4 hours later.
Category
Treatment - Other
2
Description
Control group: Patients were placed in bed at zero degree angle at the time of arrival and up to 4 hours later.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Sadoughi Hospital
Full name of responsible person
Farzane Sedighi
Street address
Shahid Sadoughi Hospital., Abn Sina Blvd., Safaie., Yazd
City
Yazd
Province
Yazd
Postal code
8916886938
Phone
+98 35 3822 9007
Email
sedighifarzane@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Navid Nasirizade
Street address
Deputy of research and technology., Islamic Azad University., Alam Sq., Yazd Town
City
Yazd
Province
Yazd
Postal code
8915813135
Phone
+98 35 3821 1391
Fax
+98 35 3821 4810
Email
research@iauyazd.ac.ir
Web page address
http://www.iauyazd.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Islamic Azad University
Full name of responsible person
Farzane Sedighi
Position
Graduated Master of Nursing Intensive Care
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Islamic Azad University., Alam Sq., Yazd Town
City
Yazd
Province
Yazd
Postal code
8915813135
Phone
+98 35 3821 1391
Fax
+98 35 3821 4810
Email
sedighifarzane@yahoo.com
Web page address
https://www.iauyazd.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Masoumeh Barkhordari
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Islamic Azad University., Alam Sq., Yazd Town
City
Yazd
Province
Yazd
Postal code
8915813135
Phone
+98 35 3821 1391
Fax
+98 35 3821 4810
Email
barkhordary_m@yahoo.com
Web page address
http://www.iauyazd.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Farzane Sedighi
Position
Graduated Master of Nursing Intensive Care
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Islamic Azad University., Alam Sq., Yazd Town
City
Yazd
Province
Yazd
Postal code
8915813135
Phone
+98 35 3821 1391
Fax
+98 35 3821 4810
Email
sedighifarzane@yahoo.com
Web page address
http://www.iauyazd.ac.ir/
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available