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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Laughter Yoga
• Intervention / Treatment: Other: group-based laughter yoga

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.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yasemin Aydın Kartal Assoc. Prof. Dr.; Phone Number: +90 543 287 00 29; Email: yasemin.aydin@sbu.edu.tr
• Study Contact Backup: Name: Aleyna Bulut Research Assistant; Phone Number: +90 536 562 61 84; Email: aleyna.bulut@sbu.edu.tr

Study Locations

• Turkey
  • Istanbul, Turkey
    • University of Health Sciences
    • Contact: Yasemin Aydın Kartal Assoc. Prof. Dr.; Phone Number: +90 543 287 00 29; Email: yasemin.aydin@sbu.edu.tr
    • Contact: Aleyna Bulut Research Assistant; Phone Number: +90 562 61 84; Email: aleyna.bulut@sbu.edu.tr
    • Principal Investigator: Yasemin Aydın Kartal Assoc. Prof. Dr.
    • Sub-Investigator: Aleyna Bulut Research Assistant
    • Sub-Investigator: Sema Aker Research Assistant

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Being a midwifery graduate and working actively in the field
• Volunteering to participate in the research

Exclusion Criteria:

• Any psychiatric diagnosis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group (Laughter yoga group) (n:40); Laughter yoga will be practiced to midwives in the intervention group.	Other: group-based laughter yoga; 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.
No Intervention: Control Group (n:40); The control group will not be subjected to any application.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Before application
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.	Before application
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.	Before application

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	4-6 weeks after application
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.	4-6 weeks after application

Collaborators and Investigators

• Sponsor: Saglik Bilimleri Universitesi
• Investigators: Principal Investigator: Yasemin Aydın Kartal Assoc. Prof. Dr., Saglik Bilimleri Universitesi; Study Chair: Aleyna Bulut Research Assistant, Saglik Bilimleri Universitesi; Study Chair: Sema Aker Research Assistant, Saglik Bilimleri Universitesi

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2023
• Primary Completion (Estimated): March 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: June 24, 2023
• First Submitted That Met QC Criteria: July 3, 2023
• First Posted (Actual): July 6, 2023

Study Record Updates

• Last Update Posted (Actual): July 6, 2023
• Last Update Submitted That Met QC Criteria: July 3, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: yoga; psychological well-being; laugh; secondary trauma
• Additional Relevant MeSH Terms: Behavioral Symptoms; Stress, Psychological; Occupational Stress; Mental Fatigue; Fatigue; Compassion Fatigue
• Other Study ID Numbers: SBU-AYDINKARTAL002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No