The Effect of Laughter Yoga on the Stress Levels of Infertility Women

July 19, 2023 updated by: Aslı SİS ÇELİK, Ataturk University

The Effect of Laughter Yoga on the Stress Levels of Infertility Women: A Randomized Controlled Trial

This research is a randomized controlled study to evaluate the effect of Laughter yoga on the stress levels of infertility women. Randomization was provided in the sample included in the study, and it was divided into experimental and control groups. At the beginning of the study, the Infertility Stress Scale was applied to women in both groups to determine their stress levels. Afterwards, 8 sessions of laughter yoga were applied to the experimental group for 4 weeks. No application was made to the control group. After 4 weeks, the Infertility Stress Scale was administered to the women in both groups to re-determine their stress levels.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This research is a randomized controlled study to evaluate the effect of Laughter yoga on the stress levels of infertility women. At the beginning of the study, necessary ethics committee permission and institutional permissions were obtained. Both of the researchers have a certificate of leadership in laughter yoga. As a result of the power analysis, it was determined that 80 women should be included in the study. Considering that there may be losses, it was decided to include 90 women in the study. By providing randomization, 90 women who met the sampling criteria and volunteered to participate in the study were divided into two groups as 45 experimental and 45 control. At the beginning of the study, the Infertility stress scale was applied to women in both groups to determine their stress levels. Afterwards, 8 sessions of laughter yoga were applied to the experimental group for 4 weeks, two sessions a week. No application was made to the control group. After 4 weeks, the Infertility stress scale was administered to the women in both groups to re-determine their stress levels.

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Yakutiye
      • Erzurum, Yakutiye, Turkey, 25240
        • Ataturk University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • be between the ages of 19-45
  • have been diagnosed with infertility
  • At least primary school graduate
  • Not having a diagnosed psychiatric disease
  • Will not have an ovulation pick up process, Intrauterine insemination and Embryo transfer procedure in the next 1 month

Exclusion Criteria:

  • Have ovulation pick up process in the last 1 month
  • undergoing Intrauterine insemination in the last 1 month
  • undergoing an Embryo transfer in the last 1 month
  • Not regularly attending laughter yoga sessions (for the experimental group)
  • Applying another alternative method to reduce stress during the research process

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimantal Group
In the study, 8 sessions of laughter yoga will be applied to the women in the experimental group twice a week for 4 weeks.
Behavioral: Laughter Yoga
  • Warm-up exercises (5 minutes),
  • Deep breathing exercises (5 minutes),
  • Childlike playfulness (5 minutes),
  • Laughter exercises (15 minutes).
No Intervention: Control Group
no intervention will be applied to the control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stress levels of women
Time Frame: 1 month
The difference between the infertility stress scale pretest and posttest mean scores of women in both groups. Higher scores indicate increased stress.
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ataturk University

Investigators

  • Study Director: Aslı SİS ÇELİK, Ataturk University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 10, 2022

Primary Completion (Actual)

February 10, 2023

Study Completion (Estimated)

June 30, 2024

Study Registration Dates

First Submitted

April 14, 2023

First Submitted That Met QC Criteria

April 14, 2023

First Posted (Actual)

April 26, 2023

Study Record Updates

Last Update Posted (Actual)

July 20, 2023

Last Update Submitted That Met QC Criteria

July 19, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • aslı14

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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