NCT06382090

Brief Summary

In addition to physical and emotional effects, premenstrual syndrome can negatively affect the participation in classes, school success, social activities and family relationships of young adolescents in high school. Many non-pharmacological treatments have been found to improve premenstrual syndromes in adolescents. Laughter yoga, one of these methods, is a practice consisting of deep breathing exercises and laughter exercises. Laughter yoga has been studied in different sample groups (elderly people, nurses, dialysis patients, etc.) and positive results have been obtained. In this study, the effect of laughter yoga on premenstrual symptoms in adolescents will be examined.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2024

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

April 20, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 24, 2024

Completed
2 days until next milestone

Study Start

First participant enrolled

April 26, 2024

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 24, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 24, 2025

Completed
Last Updated

April 24, 2024

Status Verified

April 1, 2024

Enrollment Period

28 days

First QC Date

April 20, 2024

Last Update Submit

April 20, 2024

Conditions

Keywords

Laughter YogaPremenstrual SyndromeAdolescent

Outcome Measures

Primary Outcomes (1)

  • Premenstrual Symptom Scale

    Premenstrual Syndrome Scale is a five-point Likert type scale with 44 items. In the application of PMSS, as stated in the instruction at the beginning, after reading the item, marking is made according to whether this situation is "one week before menstruation", taking into account the degrees to the right of the relevant item. In scoring the scale, the "Never" option is evaluated as 1 point, the "Very little" option is evaluated as 2 points, the "Sometimes" option is evaluated as 3 points, the "Often" option is evaluated as 4 points and the "Always" option is evaluated as 5 points. The scale has a total of nine subscales: Depressive Affect, Anxiety, Fatigue, Irritability, Depressive Thoughts, Pain, Appetite Changes, Sleep Changes and Bloating. The higher the score, the more intense the premenstrual syndrome symptoms are considered.

    5 weeks

Study Arms (2)

Laughter yoga

EXPERIMENTAL

Premenstrual syndrome scale will be applied to adolescents as a pre-test. 34 randomly selected students who pass the cutoff score on this scale will form the experimental group. A total of 10 sessions of laughter yoga will be performed for this group, twice a week for 5 weeks. At the end of the tenth session, the premenstrual syndrome scale will be re-applied to the experimental group as a post-test.

Other: Laughter yoga

Control

NO INTERVENTION

Premenstrual syndrome scale will be applied to adolescents as a pre-test. 34 randomly selected students who pass the cutoff score on this scale will form the control group. No intervention will be applied to this group. At the end of five weeks, the premenstrual syndrome scale will be applied again to the control group as a post-test.

Interventions

This practice, which includes deep breathing exercises and laughter exercises, takes approximately 45 minutes. The sessions will be conducted by the principal investigator.

Laughter yoga

Eligibility Criteria

Age12 Years - 17 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Agreeing to participate in the research
  • Having a regular menstrual cycle (menstruation every 21-35 days and without complaints of intermittent bleeding) for the last 6 months
  • Not receiving medical treatment for PMS

You may not qualify if:

  • Not agreeing to participate in the research
  • Having had any surgical operation in the last 3 months
  • Presence of a chronic disease (asthma, DM, etc.)
  • Presence of gynecological disease
  • Using hormonal contraception (such as oral contraceptives and injections).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Premenstrual SyndromeLaughter

Interventions

Laughter Therapy

Condition Hierarchy (Ancestors)

Menstruation DisturbancesPathologic ProcessesPathological Conditions, Signs and SymptomsNonverbal CommunicationCommunicationBehavior

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Two groups: comparative experiment and control
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

April 20, 2024

First Posted

April 24, 2024

Study Start

April 26, 2024

Primary Completion

May 24, 2024

Study Completion

May 24, 2025

Last Updated

April 24, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share