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

Laughter Yoga Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05933915
• Other study ID #: SBU-AYDINKARTAL002
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: August 1, 2024

Study information

• Verified date: July 2023
• Source: Saglik Bilimleri Universitesi
• Contact: Yasemin Aydin Kartal Assoc. Prof. Dr.
• Phone: +90 543 287 00 29
• Email: yasemin.aydin[@]sbu.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: August 1, 2024
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Being a midwifery graduate and working actively in the field

• Volunteering to participate in the research

Exclusion Criteria:

• Any psychiatric diagnosis

Related Conditions & MeSH terms

• Compassion Fatigue
• Laughter Yoga

Intervention

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.

Locations

Country	Name	City	State
Turkey	University of Health Sciences	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Saglik Bilimleri Universitesi

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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