Protocol summary

Study aim
Specific Objectives: 1. Determination and comparison of mean sleep quality score and quality of work life in operating room staff of hospitals affiliated to Shiraz University of Medical Sciences based on demographic characteristics before and after intervention in both groups (control group and intervention group) 2. Determination of relationship between sleep quality score and quality of work life of operating room staff of Shiraz University of Medical Sciences hospitals before and after intervention 3. Determination of difference in sleep quality score of operating room staff of hospitals affiliated to Shiraz University of Medical Sciences based on demographic characteristics before and after intervention in both groups 4. Determination of the difference in quality of work life of operating room personnel of hospitals affiliated to Shiraz University of Medical Sciences based on demographic characteristics before and after intervention in both groups
Design
The clinical trial consisted of two control and intervention groups, simple randomized. 180 sample numbersاتاق
Settings and conduct
operating room in hospital
Participants/Inclusion and exclusion criteria
1- Having at least an associate's degree or bachelor's degree in operating room personnel 2- Having a desire to participate in research 3. They have not taken any pain medication in the past month (21, 26). 4. According to the standards of the questionnaires, a Pittsburgh score of less than or equal to 5 and a Walton score of moderate (56-88) and low (24-55) are required (6). Exclusion criteria: During the intervention, each person in both groups (control and intervention) had taken sedative and sedative medication. 2. The daily performance log table is empty
Intervention groups
Operating Room Personnel Associate Degree and Master of Operating Room
Main outcome variables
Quality of sleep, quality of working life

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20100919004775N12
Registration date: 2019-10-31, 1398/08/09
Registration timing: registered_while_recruiting

Last update: 2019-10-31, 1398/08/09
Update count: 0
Registration date
2019-10-31, 1398/08/09
Registrant information
Name
Zinat Mohebbi
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1647 4254
Email address
zmohebi@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-22, 1398/06/31
Expected recruitment end date
2019-11-21, 1398/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Benson relaxation on sleep quality and quality of work life of operating room staff
Public title
The effect of Benson relaxation on sleep quality and quality of working life
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Minimum of associate's degree or bachelor's degree in practice room Personnel Willing to participate in research Have not used hypnotic drugs in the past month
Exclusion criteria:
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 180
Randomization (investigator's opinion)
Randomized
Randomization description
Specify sample size: Sample size was randomly assigned using NCSS software with 80% power, 5% type I error, and using similar data (24), mean and standard deviation, in control group (32) and intervention group (95%). / 52) 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 one 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 group as the numbers that emerge. To compensate for the loss, the number of intervention and control groups will be greater than 90 each.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
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
Eram. khabgah Eram6
City
Shiraz
Province
Fars
Postal code
7194685791
Approval date
2019-08-28, 1398/06/06
Ethics committee reference number
1398.657

Health conditions studied

1

Description of health condition studied
Work life quality
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Sleep Quality: A state of sleep that can be defined as its effect on the amount of fatigue during waking up during the day or the feeling of being happy and well after waking up and the number of waking up at night. Sleep quality, sedentary sleep, feeling of well-being and well-being after waking up in operating room personnel during the intervention were measured before and after the intervention using the Pittsburgh Sleep Quality Assessment Tool. In this study, operating room personnel will be recruited based on the scale of the questionnaire if they score less than or equal to 5.
Timepoint
Before the intervention and 2 months after the intervention
Method of measurement
Pittsburgh Sleep Quality Questionnaire

2

Description
Quality of Work Life: How much one feels and understands the physical and psychological state of their workplace. In this study, quality of work life is a score obtained by operating room personnel. What improves it is to increase hospital productivity. Before and after the intervention, Walton measured the quality of work life. In this study, operating room staff will be recruited based on the scale of the questionnaire if they score moderate (56-88) and low (24-55) on the quality of working life.
Timepoint
before the intervention and 2 months after the invention
Method of measurement
Waltons questionnair

Secondary outcomes

1

Description
Benson Relaxation Intervention: Relaxation is a state in which one's stress is at a low level and emotional levels, especially anxiety, fear and anger, are reduced. The process used to create this condition is called relaxation or relaxation. In a specific sense, the return of a contracted muscle back to its original state of relaxation is the purpose of this study of relaxation, a method introduced by Herbert Benson in 1970 and performed in four stages: 1. Providing a relaxed environment. Being in a comfortable state of mind3- Creating a mental focus 4- Creating a passive state of sampling The subjects are asked to do it twice a day for 20 minutes each time for 4 weeks.
Timepoint
During the intervention for 2 months
Method of measurement
Pittsburgh Sleep Quality Questionnaire and Walton Quality of Work Life Questionnaire

Intervention groups

1

Description
Intervention group: Intervention group: Operating room personnel with bachelor's, associate's and master's degree, obtained a score of less than or equal to 5 by the Pittsburgh Questionnaire and a mean score (56-88) and a low score (24-55) by the Quality of Work Questionnaire. They practice Benson relaxation for 2 months. After that, they receive the questionnaires again and calculate their effects by calculating their scores.
Category
Lifestyle

2

Description
Control group: Operating room personnel with a bachelor's, associate's, and master's degree, earned a score of less than or equal to 5 using the Pittsburgh Questionnaire and a moderate (56-88) and a low (24-55) quality of work life questionnaire. They do not practice Benson relaxation for 2 months and during this time they do not take any traditional or traditional sedatives.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Namazi Hhospital, Rajaii, Chamran, Khalili, Shahid Faghihi
Full name of responsible person
Maryam Ghanavati
Street address
Eram. khabgah eram6.room26
City
Shiraz
Province
Fars
Postal code
7194685791
Phone
+98 71 3628 2700
Email
technologist96@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
janghorban zade
Street address
zand
City
Shiraz
Province
Fars
Postal code
7194685791
Phone
+98 71 3628 2700
Email
technologist96@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Shiraz University 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
Maryam Ghanavati
Position
msc student
Latest degree
Master
Other areas of specialty/work
surgery
Street address
Eram
City
Shiraz
Province
Fars
Postal code
7194685791
Phone
+98 71 3628 2700
Email
Technologist96@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
maryam ghanavati
Position
msc student
Latest degree
Master
Other areas of specialty/work
surgery
Street address
eram
City
Shiraz
Province
Fars
Postal code
7194685791
Phone
+98 71 3628 2700
Email
technologist96@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
maryam ghanavati
Position
msc student
Latest degree
Master
Other areas of specialty/work
surgery
Street address
eram
City
shiraz
Province
Fars
Postal code
7194685791
Phone
+98 71 3628 2700
Email
technologist96@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
Information on the impact of the secondary outcome on the primary outcome is published.
When the data will become available and for how long
One year after the results were published
To whom data/document is available
Research 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 09386688127 or email Maryam Ghavnati. technologist96@gmail.com
What processes are involved for a request to access data/document
Requesting the above email will request the results of the research.
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