Clinical trial NCT06579118: The Impact of Laughter Yoga on Symptom Management and Quality of Life in Postmenopausal Women
Official title: The Impact of Laughter Yoga on Symptom Management and Quality of Life in Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Menopause
Keywords: laughter yoga
menopause
symptom
quality of life
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2024-08-30
Enrollment: 120
Sex: FEMALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study aimed to assess the impact of laughter yoga intervention on symptomatology and quality of life among postmenopausal women.The research was conducted in a randomized controlled experimental design.The sample comprised 128 postmenopausal women (64 in the experimental group and 64 in the control group) who attended the Gynecology Polyclinic at Atatürk University Health Research and Application Center.

Detailed description: The population of the research consisted of menopausal women who applied to the Gynecology Polyclinic of Atatürk University Health Research and Application Center between 25.08.2023 and 15.12.2023. To determine the sample size of the study, a priori power analysis was performed in the G\* Power 3.1.9.7 program. Based on the medium effect size (0.5), the alpha value was determined as 5% and the theoretical power was determined as 95%, and the minimum sample size was determined as 64. The sample of the study consisted of 128 women, 64 experimental and 64 control, who met the research criteria and agreed to participate in the research. However, since 8 people in the experimental group could not continue laughter yoga, the study was completed with 120 women.

Criteria for inclusion in the study

* Entering natural menopause,
* Being over 45 years old,
* Being at least a primary school graduate (in order to be able to fill out the forms),
* Agreeing to participate in the research voluntarily,
* Not having any hearing or vision problems (in order to be able to perform the sessions),
* No diagnosed psychiatric disease,
* Knowing Turkish,
* Having a smart mobile phone
* Being open to communication and cooperation.

Exclusion criteria from the study

• Not continuing with laughter yoga sessions.

Data were collected using the "Personal Information Form," "Menopause Rating Scale," and "Menopause-Specific Quality of Life Scale." Laughter yoga was used as an intervention tool in the research.Participants in the experimental group underwent laughter yoga sessions twice weekly for four weeks, totaling eight sessions.

The data were collected by the researcher through a face-to-face interview in a suitable empty room at Atatürk University Health Research and Application Center Gynecology Polyclinic. In order to enable women to answer the questions comfortably, each woman was interviewed alone in a separate room in the relevant outpatient clinic. Application of the questionnaire and scales took an average of 10-15 minutes for each woman. Before starting the research, women were informed about the purpose, method, rights and responsibilities of the research.

Process steps experimental group

* Written consent was obtained from menopausal women who agreed to participate in the study.
* 10 minutes before starting the laughter yoga, women in menopause were asked to fill out the "Personal Information Form", "Menopause Rating Scale" and "Menopause-Specific Quality of Life Scale" in order to determine their descriptive characteristics.
* A total of 8 sessions of laughter yoga were applied for 4 weeks, 2 sessions per week. The first session lasted 45 minutes, all other sessions lasted an average of 30 minutes. In the first session, laughter yoga, its history, benefits, breathing techniques, laughter yoga exercises were mentioned before the exercises, and in the following sessions, reminders were made and the session ended with laughter yoga exercises and breathing exercises.
* After 4 weeks, the process was completed by having women in menopause fill out the "Menopause Rating Scale" and the "Menopause-Specific Quality of Life Scale".

control group

* Written consent was obtained from pregnant women who agreed to participate in the study.
* In order to determine the descriptive characteristics of menopausal women, they were asked to fill out the "Personal Information Form", "Menopause Symptoms Evaluation Scale" and "Menopause-Specific Quality of Life Scale".
* After 4 weeks, the process was completed by having women in menopause fill out the "Menopause Rating Scale" and "Menopause-Specific Quality of Life Scale".

Data analysis included Skewness and Kurtosis values, frequency and percentage distributions, Chi-square tests, Independent Samples t-test, Paired Samples t-test, Mann-Whitney U test, Wilcoxon signed-rank test, and regression analysis. All ethical principles were adhered to throughout the study.

Eligibility criteria: Inclusion Criteria:

* Entering natural menopause,
* Being over 45 years old,
* Being at least a primary school graduate (in order to be able to fill out the forms),
* Agreeing to participate in the research voluntarily,
* Not having any hearing or vision problems (in order to be able to perform the sessions),
* No diagnosed psychiatric disease,
* Knowing Turkish,
* Having a smart mobile phone
* Being open to communication and cooperation.

Exclusion Criteria:

* Not continuing with laughter yoga sessions.

Primary outcomes:
measure: Personal Information Form
timeFrame: 5 months
measure: Menopause Rating Scale
timeFrame: 5 months
measure: Menopause-Specific Quality of Life Scale
timeFrame: 5 months
Secondary outcomes:
Other outcomes:
Locations:
city: Yakutiye
country: Turkey
facility: Ayşe Aydın
state: Erzurum
Study officials:
affiliation: Ataturk University
name: Ayşe Aydın
role: PRINCIPAL_INVESTIGATOR
References: