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

Laughter Yoga Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05831280
• Other study ID #: asli14
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 10, 2022
• Est. completion date: June 30, 2024

Study information

• Verified date: July 2023
• Source: Ataturk University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 90
• Est. completion date: June 30, 2024
• Est. primary completion date: February 10, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 19 Years to 49 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility
• Laughter Yoga

Intervention

Behavioral:
• Laughter Yoga
Warm-up exercises (5 minutes), Deep breathing exercises (5 minutes), Childlike playfulness (5 minutes), Laughter exercises (15 minutes).

Locations

Country	Name	City	State
Turkey	Atatürk University	Erzurum	Yakutiye

Sponsors (1)

Lead Sponsor	Collaborator
Ataturk University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 month