NCT05859399

Brief Summary

The research was planned as a prospective, randomized controlled experimental study to determine the effect of laughter yoga applied to midwifery students on premenstrual symptoms (PMS) and quality of life. Research Hypotheses H0: Online laughter yoga has no effect on premenstrual symptoms. H1: Online laughter yoga has an effect on premenstrual symptoms. H0: Online laughter yoga has no effect on quality of life. H1: Online laughter yoga has an impact on quality of life.

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
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2023

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

May 5, 2023

Completed
10 days until next milestone

Study Start

First participant enrolled

May 15, 2023

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 16, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

May 16, 2023

Status Verified

May 1, 2023

Enrollment Period

5 months

First QC Date

May 5, 2023

Last Update Submit

May 15, 2023

Conditions

Premenstrual SyndromeQuality of Life

Keywords

Premenstrual SyndromeQuality of lifeLaughter yogaLaughter therapyStudent

Outcome Measures

Primary Outcomes (1)

  • Premenstrual Syndrome Scale (PMSS)

    The Premenstrual Syndrome Scale is a five-point Likert type scale consisting of 44 questions that measures the severity of premenstrual symptoms, based on DSM-III and DSM-IV-R, in order to measure the severity of premenstrual symptoms

    change from baseline, at the end of 12th week of intervention.

Secondary Outcomes (1)

  • World Health Organization Quality of Life Instrument, Short Form (WHOQOL-BREF)

    change from baseline, at the end of 12th week of intervention.

Study Arms (2)

Experimental (laughter yoga) group

EXPERIMENTAL

The intervention group will receive 12 online laughter yoga sessions, only one session per week for 12 weeks. In this study, the number of laughter yoga sessions was determined in line with the studies in the literature. Each laughter yoga session is planned to last approximately 40-45 minutes. Each session of laughter yoga consists of clapping and warm-up exercises, deep breathing exercises, childlike play and laughter.

Other: Laughter yoga

Control group

NO INTERVENTION

The control group will receive no intervention for 12 weeks.

Interventions

Laughter yogaOTHER

Although the history of laughter yoga dates back to ancient times, its use in medicine has become widespread in the 21st century, while it is used to reduce pain, anxiety, stress, depression and fatigue, it is also a method that can be used to accelerate immunity, quality of life, happiness, sleep quality and recovery.

Also known as: Laughter therapy
Experimental (laughter yoga) group

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • To agree to participate in the research,
  • To be over 18 years old,
  • Not having taken vocational courses
  • Not having a chronic disease,
  • Having a regular menstrual period,
  • Having at least 110 points on the PMS scale
  • Not receiving medical treatment for PMS.

You may not qualify if:

  • Refusing to participate in the research,
  • To have taken vocational courses,
  • Having a chronic illness
  • Getting a score lower than 110 on the PMS scale,
  • Having any condition where laughter yoga should be avoided (having had abdominal surgery in the last three months, taking regular medications, epilepsy, uncontrollable hypertension, glaucoma, hernia, etc.)
  • Receiving medical treatment for PMS.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Premenstrual Syndrome

Interventions

Laughter Therapy

Condition Hierarchy (Ancestors)

Menstruation DisturbancesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeutics

Central Study Contacts

Ahu AKSOY CAN, PhD

CONTACT

05444825892aksoyahu91@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Statistical analysis of the data will be done by an expert independent of the research.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Prospective, parallel, two arm, randomized controlled clinical trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant, PhD

Study Record Dates

First Submitted

May 5, 2023

First Posted

May 16, 2023

Study Start

May 15, 2023

Primary Completion

September 30, 2023

Study Completion

December 31, 2023

Last Updated

May 16, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share