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

Primary Purpose

Laughter Yoga

Status
Active
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Laughter Yoga
Sponsored by
Ataturk University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Laughter Yoga focused on measuring Laughter Yoga, Infertility, Stress, Nurse

Eligibility Criteria

19 Years - 49 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Atatürk University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimantal Group

Control Group

Arm Description

In the study, 8 sessions of laughter yoga will be applied to the women in the experimental group twice a week for 4 weeks.

no intervention will be applied to the control group

Outcomes

Primary Outcome Measures

Stress levels of women
The difference between the infertility stress scale pretest and posttest mean scores of women in both groups. Higher scores indicate increased stress.

Secondary Outcome Measures

Full Information

First Posted
April 14, 2023
Last Updated
July 19, 2023
Sponsor
Ataturk University
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1. Study Identification

Unique Protocol Identification Number
NCT05831280
Brief Title
The Effect of Laughter Yoga on the Stress Levels of Infertility Women
Official Title
The Effect of Laughter Yoga on the Stress Levels of Infertility Women: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 10, 2022 (Actual)
Primary Completion Date
February 10, 2023 (Actual)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ataturk University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Laughter Yoga
Keywords
Laughter Yoga, Infertility, Stress, Nurse

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial
Masking
ParticipantOutcomes Assessor
Masking Description
The women in the experimental and control groups did not know which group they were in. Data were collected online due to the pandemic. Therefore, the researchers and the people who would conduct the analyzes did not know the women in the experimental and control groups. The women used a nickname to fill in the questions on the measurement tools.
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimantal Group
Arm Type
Experimental
Arm Description
In the study, 8 sessions of laughter yoga will be applied to the women in the experimental group twice a week for 4 weeks.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
no intervention will be applied to the control group
Intervention Type
Behavioral
Intervention Name(s)
Laughter Yoga
Intervention Description
Warm-up exercises (5 minutes), Deep breathing exercises (5 minutes), Childlike playfulness (5 minutes), Laughter exercises (15 minutes).
Primary Outcome Measure Information:
Title
Stress levels of women
Description
The difference between the infertility stress scale pretest and posttest mean scores of women in both groups. Higher scores indicate increased stress.
Time Frame
1 month

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aslı SİS ÇELİK
Organizational Affiliation
Ataturk University
Official's Role
Study Director
Facility Information:
Facility Name
Atatürk University
City
Erzurum
State/Province
Yakutiye
ZIP/Postal Code
25240
Country
Turkey

12. IPD Sharing Statement

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

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