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

NCT ID: NCT05831280

Last Updated: 2023-07-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-10

Study Completion Date

2024-06-30

Brief Summary

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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

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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.

Conditions

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Laughter Yoga

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled trial
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors
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.

Study Groups

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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.

Group Type EXPERIMENTAL

Laughter Yoga

Intervention Type BEHAVIORAL

* Warm-up exercises (5 minutes),
* Deep breathing exercises (5 minutes),
* Childlike playfulness (5 minutes),
* Laughter exercises (15 minutes).

Control Group

no intervention will be applied to the control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Laughter Yoga

* Warm-up exercises (5 minutes),
* Deep breathing exercises (5 minutes),
* Childlike playfulness (5 minutes),
* Laughter exercises (15 minutes).

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Ataturk University

OTHER

Sponsor Role lead

Responsible Party

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Aslı SİS ÇELİK

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Aslı SİS ÇELİK

Role: STUDY_DIRECTOR

Ataturk University

Locations

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Atatürk University

Erzurum, Yakutiye, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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aslı14

Identifier Type: -

Identifier Source: org_study_id

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