Protocol summary

Summary
To assess the effect of changing position and early ambulation on the urinary retention, back pain, bleeding and hematoma after cardiac catheterization. Methods: This is a quasi-experimental study, including four groups of 35 patients (140 samples with random sampling). group A received a common protocol, remaining supine and flat in bed for 6 hours. Patients in group B were positioned after Angiography as the first time sleeping in the back and the head of the bed was raised to an angle of 15 degree; in the second hour head of the bed was changed to 30 and in the third hour to 45; then position was changed to the right side for half an hour and to the left side for another half an hour, and in the sixth hour the patient was allowed to get out of the bed. In group C, patients had early ambulation in the fourth hour after angiography. In Group D, combination of changed position and early ambulation were used. Then the amount of bleeding, hematoma, back pain and urinary retention were measured in 0, 1, 2, 4, 6 and 24 hours after angiography. Data were collected by the use of personal information questionnaire and Numeric Pain Intensity Scale and Christenson check list for investigating the amount of bleeding and hematoma.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201108131860N2
Registration date: 2012-02-09, 1390/11/20
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2012-02-09, 1390/11/20
Registrant information
Name
Ali akbar Abdollahi
Name of organization / entity
Golestan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 17 1442 6900
Email address
abdollahi@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Gorgan university of Medical Sciences
Expected recruitment start date
2001-03-10, 1379/12/20
Expected recruitment end date
2012-03-10, 1390/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of changing position and out of bed early on some complications of cardiac catheterization
Public title
Effect of body position changes and exit prematurely on complications due to catheterization
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: age between 65-18 years; blood pressure less than 100/180 mmHg; the absence of active bleeding disorders, PT and PTT 16 seconds under 90 seconds; no history of diabetes, and sensory problems. Exclusion criteria: chest pain associated with the new change strip; the incidence of active bleeding during the procedure; serious rhythm disturbance immediately after cardiac catheterization; a history of peripheral vascular disease; previous history of back pain; history of urinary problems; use of drugs for pain, Rate translation.
Age
From 16 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 140
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
Gorgan university of Medical Sciences
Street address
Department of Research & Technology, University of medical Sciences
City
Gorgan
Postal code
568-49165
Approval date
2011-03-16, 1389/12/25
Ethics committee reference number
541/35/گ پ

Health conditions studied

1

Description of health condition studied
cardiac catheterization
ICD-10 code
I20
ICD-10 code description
Angina pectoris

Primary outcomes

1

Description
bleeding
Timepoint
0 and 1, 2, 4, 6 and 24 hours after angiography
Method of measurement
Christenson check list

2

Description
hematoma
Timepoint
0 and 1, 2, 4, 6 and 24 hours after angiography
Method of measurement
Christenson check list

3

Description
back pain
Timepoint
0 and 1, 2, 4, 6 and 24 hours after angiography
Method of measurement
Visual Analog Scale

4

Description
urinary retention
Timepoint
0 and 1, 2, 4, 6 and 24 hours after angiography
Method of measurement
Questionnaire

Secondary outcomes

1

Description
protromobin time (PT)
Timepoint
0 and 24 hours
Method of measurement
second

Intervention groups

1

Description
Group contorol : the patient would be complete bed rest during 6 hours after angiography
Category
Prevention

2

Description
Intervention group 1: the patient would be positioned after Angiography, then patient would get out of bed after 6 hours
Category
Prevention

3

Description
Intervention group 2: the patient would be complete bed rest during 4 hours after angiography and then get out of bed
Category
Prevention

4

Description
Intervention group 3: Both of position changing and early getting out of bed
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Dr Gnjvyan Hospital
Full name of responsible person
Shazad Mehranfard
Street address
City
Dezful

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Department of Research & Technology, Gorgan University of medical Sciences
Full name of responsible person
Dr Arabi
Street address
Department of Research & Technology, University of medical Sciences
City
Gorgan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Department of Research & Technology, Gorgan University of medical Sciences
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
Gorgan University of Medical Sciences
Full name of responsible person
Ali Akbar Abdollahi
Position
Faculty of Nursing and Midwifery School
Other areas of specialty/work
Street address
4th floor, Safa apartment, 2nd Dokaniat, Dokaniat complex
City
Gorgan
Postal code
4917953879
Phone
+98 17 1442 6900
Fax
Email
abdollahi@goums.ac.ir , abdollahy64@yahoo.com
Web page address
www.goums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Ali Akbar Abdollahi
Position
Faculty of Nursing and Midwifery School
Other areas of specialty/work
Street address
Faculty of nursing and Midwifery, Gorgan University of Medical Sciences, Gorgan Bouyeh
City
Gorgan
Postal code
917953879
Phone
+98 17 1442 6900
Fax
Email
abdollahi@goums.ac.ir , abdollahy64@yahoo.com
Web page address
www.goums.ac.ir

Person responsible for updating data

Contact

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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