NCT05831280

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 10, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 14, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 26, 2023

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

July 20, 2023

Status Verified

July 1, 2023

Enrollment Period

5 months

First QC Date

April 14, 2023

Last Update Submit

July 19, 2023

Conditions

Keywords

Laughter YogaInfertilityStressNurse

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Experimantal Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

no intervention will be applied to the control group

Interventions

Laughter YogaBEHAVIORAL

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

Experimantal Group

Eligibility Criteria

Age19 Years - 49 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Atatürk University

Erzurum, Yakutiye, 25240, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Infertility

Interventions

Laughter Therapy

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeutics

Study Officials

  • Aslı SİS ÇELİK

    Ataturk University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 14, 2023

First Posted

April 26, 2023

Study Start

September 10, 2022

Primary Completion

February 10, 2023

Study Completion

June 30, 2024

Last Updated

July 20, 2023

Record last verified: 2023-07

Locations