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

Sponsor
Saglik Bilimleri Universitesi (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05933915
Collaborator
(none)
80
1
2
11
7.3

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: group-based laughter yoga
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Single blind randomized controlled trialSingle blind randomized controlled trial
Masking:
Single (Participant)
Primary Purpose:
Other
Official Title:
The Effect of Laughter Yoga on the Secondary Traumatic Stress Level and Psychological Well-Being of Midwives
Anticipated Study Start Date :
Sep 1, 2023
Anticipated Primary Completion Date :
Mar 1, 2024
Anticipated Study Completion Date :
Aug 1, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Introductory Information Form [Before application]

    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.

  2. Psychological Well-Being Scale [Before application]

    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.

  3. Secondary Traumatic Stress Scale [Before application]

    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

  1. Secondary Traumatic Stress Scale [4-6 weeks after application]

    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.

  2. Psychological Well-Being Scale [4-6 weeks after application]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Being a midwifery graduate and working actively in the field

  • Volunteering to participate in the research

Exclusion Criteria:
  • Any psychiatric diagnosis

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Health Sciences Istanbul Turkey

Sponsors and Collaborators

  • 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
YASEMİN AYDIN KARTAL, Assoc. Prof. Dr., Saglik Bilimleri Universitesi
ClinicalTrials.gov Identifier:
NCT05933915
Other Study ID Numbers:
  • SBU-AYDINKARTAL002
First Posted:
Jul 6, 2023
Last Update Posted:
Jul 6, 2023
Last Verified:
Jul 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by YASEMİN AYDIN KARTAL, Assoc. Prof. Dr., Saglik Bilimleri Universitesi
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 6, 2023