1. Determination and comparison of QoL score mean in operating room personnel of hospitals affiliated to Shiraz University of Medical Sciences based on demographic characteristics before, 4 and 8 weeks after intervention in both groups (control and intervention)
2. Determination of difference in QoL score in operating room personnel of hospitals affiliated to Shiraz University of Medical Sciences based on demographic characteristics before, 4 and 8 weeks after intervention between both groups (control and intervention)
Design
A clinical trial is done with control and intervention groups, single blinding, simple randomization, on 180 operating room personnel.
Settings and conduct
Benson's relaxation intervention: In this study relaxation means a method introduced by Herbert Benson in 1970 and performed in four stages. The samples are asked to do it twice a day for 20 minutes each time, for 8 weeks. The intervention took place at Namazi, Rajaii, Chamran, Khalili and Faghihi Hospitals.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1- Having at least associate's, bachelor's or master's degree of operating room
2- Willing to participate in research
3- Gaining a QOL score less than 50, according to the SF-36 questionnaire
Exclusion criteria:
Have not completed the Benson's relaxation schedule form
Intervention groups
Intervention group: Benson's Relaxation is taught to the participants of this group. People should practice Benson's relaxation twice a day at 6-hour intervals. Control group: The participants of this group are not given relaxation.
Main outcome variables
QoL of operating room personnel according to SF-36 questionnaire that is measured before, 4 and 8 weeks after intervention.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211002052650N1
Registration date:2022-10-26, 1401/08/04
Registration timing:prospective
Last update:2022-10-26, 1401/08/04
Update count:0
Registration date
2022-10-26, 1401/08/04
Registrant information
Name
Maryam Ghanavati
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 5234 2947
Email address
technologist96@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-11-12, 1401/08/21
Expected recruitment end date
2023-02-09, 1401/11/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Benson's Relaxation on QoL in operating room personnel of hospitals affiliated to Shiraz University of Medical Sciences.
Public title
The effect of Benson's Relaxation on QoL
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Having at least َ Associate's, Bachelor's or Master's degree
Willing to participate in research
Gaining a QoL score less than 50, according to the SF-36 questionnaire
Exclusion criteria:
Not having completed the Benson's relaxation Schedule form
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
180
Randomization (investigator's opinion)
Randomized
Randomization description
Specify sample size: Sample size was simple randomly assigned using NCSS software with 80% power, 5% type I error, and using previous similar data, mean and standard deviation, in control and intervention groups, 90 persons were assigned to each group.
How to choose a sample: First, with a coin and the use of a toss, we specify that the numbers 1 to 90 (the first 90) fall into the intervention group and the numbers 91 to 180 (the second 90) into the control group. The number of cards will be numbered from 1 to 180 and will be distributed among those who meet the criteria for admission to the study. Based on the number of operating room staff in each hospital, we determine in advance how many numbers are to be assigned to each hospital and then enter the intervention and control groups as the numbers that emerge. in the same order as mentioned. To compensate for the drop, the number of intervention and control groups will be more than 90 each.
Blinding (investigator's opinion)
Single blinded
Blinding description
outcome assessor blinding
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shiraz University of Medical Sciences
Street address
Zand Street, Namazi Hospital, Nursing and Midwifery College.
City
Shiraz
Province
Fars
Postal code
71936-13119
Approval date
2020-02-16, 1398/11/27
Ethics committee reference number
IR.SUMS.REC.1398.1331
Health conditions studied
1
Description of health condition studied
Quality of life (QoL)
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
SF-36 QoL of Operating Room Personnel
Timepoint
Before, 4 and 8 weeks after intervention
Method of measurement
SF-36 QoL
Secondary outcomes
empty
Intervention groups
1
Description
Intervention Group: Benson's Relaxation is taught to Operating Room Personnel that carried out twice a day, each time for 20 minutes, at 6-hours intervals. Quality of life is measured before, 4 and 8 weeks after intervention.
Category
Lifestyle
2
Description
Control Group: The Operating Room Personnel of this group are not given teaching. Quality of life is measured before, 4 and 8 weeks after intervention.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
All of the Educational Hospitals of Shiraz.
Full name of responsible person
Zinat Mohebbi
Street address
Zand Street, Namazi Hospital, Nursing and Midwifery College.
City
Shiraz
Province
Fars
Postal code
71936-13119
Phone
+98 71 3647 4256
Fax
+98 71 3647 4252
Email
mohebbi04@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Roxana Ganghorban
Street address
Zand Street, Namazi Hospital, Nursing and Midwifery College.
City
Shiraz
Province
Fars
Postal code
71936-13119
Phone
+98 71 3647 4256
Fax
+98 71 3647 4252
Email
researchnu@sums.ac.ir
Grant name
98-01-42-20364
Grant code / Reference number
20364
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Zinat Mohebbi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Zand Street, Namazi Hospital, Nursing and Midwifery College.
City
Shiraz
Province
Fars
Postal code
71936-13119
Phone
+98 71 3647 4256
Fax
+98 71 3647 4252
Email
mohebbi04@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Zinat Mohebbi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Zand Street, Namazi Hospital, Nursing and Midwifery College.
City
Shiraz
Province
Fars
Postal code
71936-13119
Phone
+98 71 3647 4256
Fax
+98 71 3647 4252
Email
mohebbi04@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Zinat Mohebbi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Zand Street, Namazi Hospital, Nursing and Midwifery College.
City
Shiraz
Province
Fars
Postal code
71936-13119
Phone
+98 71 3647 4256
Fax
+98 71 3647 4252
Email
mohebbi04@yahoo.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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
We do not have data yet.
When the data will become available and for how long
One year after the results were published.
To whom data/document is available
Researcher, participants and hospitals.
Under which criteria data/document could be used
To the participants if they remain in the research until the last stage.
From where data/document is obtainable
Phone 00989177137573 or email Zinat Mohebbi: mohebbi04@yahoo.com.
What processes are involved for a request to access data/document
Email to Zinat Mohebbi and want the result of the research.