Clinical trial NCT05933915: 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
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Laughter Yoga
Keywords: laugh
yoga
secondary trauma
psychological well-being
Lead sponsor: Saglik Bilimleri Universitesi
Sponsor class: OTHER
First posted: 2023-07-06
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single blind randomized controlled trial
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Introductory Information Form
timeFrame: Before application
measure: Psychological Well-Being Scale
timeFrame: Before application
measure: Secondary Traumatic Stress Scale
timeFrame: Before application
Secondary outcomes:
measure: Secondary Traumatic Stress Scale
timeFrame: 4-6 weeks after application
measure: Psychological Well-Being Scale
timeFrame: 4-6 weeks after application
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: University of Health Sciences
Study officials:
affiliation: Saglik Bilimleri Universitesi
name: Yasemin Aydın Kartal Assoc. Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Saglik Bilimleri Universitesi
name: Aleyna Bulut Research Assistant
role: STUDY_CHAIR
affiliation: Saglik Bilimleri Universitesi
name: Sema Aker Research Assistant
role: STUDY_CHAIR
References: