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The Effect of Laughter Yoga on the Secondary Traumatic Stress Level and Psychological Well-Being of Midwives

Primary Purpose

Laughter Yoga

Status
Not yet recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
group-based laughter yoga
Sponsored by
Saglik Bilimleri Universitesi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Laughter Yoga focused on measuring laugh, yoga, secondary trauma, psychological well-being

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: Being a midwifery graduate and working actively in the field Volunteering to participate in the research Exclusion Criteria: Any psychiatric diagnosis

Sites / Locations

  • University of Health Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Group (Laughter yoga group) (n:40)

Control Group (n:40)

Arm Description

Laughter yoga will be practiced to midwives in the intervention group.

The control group will not be subjected to any application.

Outcomes

Primary Outcome Measures

Introductory Information Form
In this form, which was created by the researchers based on the literature, the participants' age, the high school they graduated from, their willingness to choose the profession, their feeling of belonging to the profession, the unit they work in, their working status in crisis situations, etc. questions are included.
Psychological Well-Being Scale
The scale was developed to measure current socio-psychological well-being. Scores that can be obtained from the scale range from 8 (if strongly disagree with all items) to 56 (if strongly agree with all items). It is concluded that individuals with high scores have high psychological resources.
Secondary Traumatic Stress Scale
The scale consists of 17 items and is scored with a 5-point Likert-type rating (1=Never, 5=Very often). The scale has three sub-dimensions: emotional violation, avoidance and arousal. Items numbered 2,3,6,10,13 evaluate emotional violation sub-dimension; items numbered 1,5,7,9,12,14,17 evaluate avoidance sub-dimension; items numbered 4,8,11,15,16 evaluate arousal sub-dimension. The score that can be obtained from the scale is between 17 and 85 and the increase in the score indicates a high level of affectivity.

Secondary Outcome Measures

Secondary Traumatic Stress Scale
The scale consists of 17 items and is scored with a 5-point Likert-type rating (1=Never, 5=Very often). The scale has three sub-dimensions: emotional violation, avoidance and arousal. Items numbered 2,3,6,10,13 evaluate emotional violation sub-dimension; items numbered 1,5,7,9,12,14,17 evaluate avoidance sub-dimension; items numbered 4,8,11,15,16 evaluate arousal sub-dimension. The score that can be obtained from the scale is between 17 and 85 and the increase in the score indicates a high level of affectivity.
Psychological Well-Being Scale
The scale was developed to measure current socio-psychological well-being. Scores that can be obtained from the scale range from 8 (if strongly disagree with all items) to 56 (if strongly agree with all items). It is concluded that individuals with high scores have high psychological resources.

Full Information

First Posted
June 24, 2023
Last Updated
July 3, 2023
Sponsor
Saglik Bilimleri Universitesi
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1. Study Identification

Unique Protocol Identification Number
NCT05933915
Brief Title
The Effect of Laughter Yoga on the Secondary Traumatic Stress Level and Psychological Well-Being of Midwives
Official Title
The Effect of Laughter Yoga on the Secondary Traumatic Stress Level and Psychological Well-Being of Midwives
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 1, 2023 (Anticipated)
Primary Completion Date
March 1, 2024 (Anticipated)
Study Completion Date
August 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Saglik Bilimleri Universitesi

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Aim: The aim of this study is to determine the effect of laughter yoga, which includes various relaxing practices, on secondary trauma levels and psychological well-being of midwives. The study was planned as a randomized controlled experimental study. This RCT will be administered following the CONSORT 2010 guidelines. Material and Methods: Considering the case losses in the study, it was planned to create a total of 80 midwives, 40 in the intervention group and 40 in the control group. Laughter yoga will be practiced in the intervention group. No intervention will be made on the control group. Data were collected by using the Personal Information Form, Secondary Traumatic Stress Scale, Psychological Well-Being Scale.
Detailed Description
Physiologically, laughter increases blood oxygen saturation, beta endorphin levels increase; It is stated that it has psychological effects such as reducing anxiety, stress, depression and facilitating social communication. Laughter yoga is a non-pharmacological therapy. Laughter yoga is also used to improve general health, reduce mental symptoms, and improve quality of life. Midwives will be randomly assigned to the intervention and control groups, and computer-assisted randomization, one of the fixed probability randomization methods, will be used (https://www.randomizer.org/#randomize). The study will be conducted single-blind. The researcher who will do the laughter yoga and the researcher who will apply the evaluation questionnaires will be different. The researcher who will make the analysis and evaluation will be blind to the groups of midwives. Midwives in the intervention group of the research will apply 8 sessions of laughter yoga, 2 sessions a week. Laughter yoga will be practiced by researchers with leadership certification. Each session will take an average of 45 minutes. Laughter Yoga sessions will be held on the web through the "Zoom" program. Each session will consist of groups of 8 people. Before starting the laughter yoga, 5 separate WhatsApp groups consisting of 8 people will be established to provide faster and easier communication with the midwives in the intervention group, and communication will be provided by informing and communicating about the sessions. Before starting the application, the "Zoom" program will be downloaded to the phones or computers of the midwives in the intervention group. "Secondary Traumatic Stress Scale" and "Psychological Well-Being Scale" will be applied to midwives before and 4-6 weeks after the application. Control Group: No intervention will be applied to the control group midwives, and the Secondary Traumatic Stress Scale" and "Psychological Well-Being Scale" will be applied again when they are included in the study and 4-6 weeks later.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Laughter Yoga
Keywords
laugh, yoga, secondary trauma, psychological well-being

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Single blind randomized controlled trial
Masking
Participant
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group (Laughter yoga group) (n:40)
Arm Type
Experimental
Arm Description
Laughter yoga will be practiced to midwives in the intervention group.
Arm Title
Control Group (n:40)
Arm Type
No Intervention
Arm Description
The control group will not be subjected to any application.
Intervention Type
Other
Intervention Name(s)
group-based laughter yoga
Intervention Description
Midwives in the intervention group of the research will apply 8 sessions of laughter yoga, 2 sessions a week. Laughter yoga will be practiced by researchers with leadership certification. Each session will take an average of 45 minutes. Laughter Yoga sessions will be held on the web through the "Zoom" program. Each session will consist of groups of 8 people.
Primary Outcome Measure Information:
Title
Introductory Information Form
Description
In this form, which was created by the researchers based on the literature, the participants' age, the high school they graduated from, their willingness to choose the profession, their feeling of belonging to the profession, the unit they work in, their working status in crisis situations, etc. questions are included.
Time Frame
Before application
Title
Psychological Well-Being Scale
Description
The scale was developed to measure current socio-psychological well-being. Scores that can be obtained from the scale range from 8 (if strongly disagree with all items) to 56 (if strongly agree with all items). It is concluded that individuals with high scores have high psychological resources.
Time Frame
Before application
Title
Secondary Traumatic Stress Scale
Description
The scale consists of 17 items and is scored with a 5-point Likert-type rating (1=Never, 5=Very often). The scale has three sub-dimensions: emotional violation, avoidance and arousal. Items numbered 2,3,6,10,13 evaluate emotional violation sub-dimension; items numbered 1,5,7,9,12,14,17 evaluate avoidance sub-dimension; items numbered 4,8,11,15,16 evaluate arousal sub-dimension. The score that can be obtained from the scale is between 17 and 85 and the increase in the score indicates a high level of affectivity.
Time Frame
Before application
Secondary Outcome Measure Information:
Title
Secondary Traumatic Stress Scale
Description
The scale consists of 17 items and is scored with a 5-point Likert-type rating (1=Never, 5=Very often). The scale has three sub-dimensions: emotional violation, avoidance and arousal. Items numbered 2,3,6,10,13 evaluate emotional violation sub-dimension; items numbered 1,5,7,9,12,14,17 evaluate avoidance sub-dimension; items numbered 4,8,11,15,16 evaluate arousal sub-dimension. The score that can be obtained from the scale is between 17 and 85 and the increase in the score indicates a high level of affectivity.
Time Frame
4-6 weeks after application
Title
Psychological Well-Being Scale
Description
The scale was developed to measure current socio-psychological well-being. Scores that can be obtained from the scale range from 8 (if strongly disagree with all items) to 56 (if strongly agree with all items). It is concluded that individuals with high scores have high psychological resources.
Time Frame
4-6 weeks after application

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Being a midwifery graduate and working actively in the field Volunteering to participate in the research Exclusion Criteria: Any psychiatric diagnosis
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yasemin Aydın Kartal Assoc. Prof. Dr.
Phone
+90 543 287 00 29
Email
yasemin.aydin@sbu.edu.tr
First Name & Middle Initial & Last Name or Official Title & Degree
Aleyna Bulut Research Assistant
Phone
+90 536 562 61 84
Email
aleyna.bulut@sbu.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yasemin Aydın Kartal Assoc. Prof. Dr.
Organizational Affiliation
Saglik Bilimleri Universitesi
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Aleyna Bulut Research Assistant
Organizational Affiliation
Saglik Bilimleri Universitesi
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Sema Aker Research Assistant
Organizational Affiliation
Saglik Bilimleri Universitesi
Official's Role
Study Chair
Facility Information:
Facility Name
University of Health Sciences
City
Istanbul
Country
Turkey
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yasemin Aydın Kartal Assoc. Prof. Dr.
Phone
+90 543 287 00 29
Email
yasemin.aydin@sbu.edu.tr
First Name & Middle Initial & Last Name & Degree
Aleyna Bulut Research Assistant
Phone
+90 562 61 84
Email
aleyna.bulut@sbu.edu.tr
First Name & Middle Initial & Last Name & Degree
Yasemin Aydın Kartal Assoc. Prof. Dr.
First Name & Middle Initial & Last Name & Degree
Aleyna Bulut Research Assistant
First Name & Middle Initial & Last Name & Degree
Sema Aker Research Assistant

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effect of Laughter Yoga on the Secondary Traumatic Stress Level and Psychological Well-Being of Midwives

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