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Clinical Trials/NCT06947434
NCT06947434CompletedNot Applicable

Effects of Laughter Yoga on Sexual Functioning, Anxiety, Depression, Fatigue, and Quality of Life in Patients With Multiple Sclerosis: A Quasi-Experimental Study

Istanbul University1 site in 1 country26 target enrollmentStarted: March 1, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
26
Locations
1
Primary Endpoint
Change in Sexual Functioning (MSISQ-19 Total Score)

Study Overview

Brief Summary

The goal of this clinical trial is to evaluate whether laughter yoga can improve sexual functioning and reduce psychological symptoms in adults diagnosed with multiple sclerosis (MS). The main questions it aims to answer are:

Does laughter yoga improve sexual functioning in individuals with MS?

Does laughter yoga reduce anxiety, depression, and fatigue, and improve quality of life in this population?

Participants will:

Attend 10 online laughter yoga sessions over 5 weeks (2 sessions per week, 40 minutes each)

Complete online questionnaires before, during, and after the intervention to assess sexual functioning, anxiety, depression, fatigue, and quality of life

Detailed Description

This quasi-experimental study investigates the effectiveness of laughter yoga in improving sexual functioning and psychosocial outcomes in adults with multiple sclerosis (MS). Laughter yoga is a behavioral intervention combining voluntary laughter with yogic breathing techniques, aiming to enhance emotional well-being and reduce stress-related symptoms.

The study includes three assessment points: baseline (pretest), five weeks after the baseline (pre-intervention), and post-intervention. The intervention consists of 10 structured laughter yoga sessions conducted via Zoom over a 5-week period. Each session lasts approximately 40 minutes and includes rhythmic clapping, deep breathing exercises, playful activities, and simulated laughter practices guided by a certified laughter yoga facilitator.

Validated self-report instruments are used to assess sexual functioning, anxiety, depression, fatigue, and quality of life. The study specifically targets individuals with MS who report sexual problems and experience mild to moderate psychological symptoms.

The primary aim is to determine the effect of laughter yoga on sexual functioning (measured by MSISQ-19). Secondary outcomes include changes in anxiety, depression, fatigue, and health-related quality of life. This study seeks to explore laughter yoga as a feasible, non-pharmacological, and low-cost approach to improving multidimensional well-being in MS patients.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Age 18 years or older
  • •Diagnosed with multiple sclerosis (MS)
  • •Literate and able to complete self-report questionnaires
  • •Expanded Disability Status Scale (EDSS) score < 4
  • •HADS-Anxiety score > 10
  • •HADS-Depression score > 7
  • •Reporting sexual problems based on MSISQ-19
  • •Having an active sexual life
  • •Access to internet and a device capable of video conferencing
  • •Willing to participate and able to attend all 10 laughter yoga sessions

Exclusion Criteria

  • •MS relapse or acute exacerbation within the last 3 months
  • •Severe cognitive impairment or communication difficulties
  • •Current participation in any laughter therapy, yoga, or similar psychosocial intervention
  • •Diagnosis of a major psychiatric disorder (e.g., schizophrenia, bipolar disorder)
  • •Unwillingness or inability to provide informed consent

Arms & Interventions

Single Arm

Experimental

Participants in this single-arm study will undergo a structured laughter yoga intervention after a 5-week observation period without any intervention. The intervention consists of 10 sessions delivered over the subsequent 5 weeks (2 sessions per week). Each session lasts approximately 40 minutes and is conducted online via Zoom. Sessions include four core components: rhythmic clapping, deep breathing exercises (pranayama), playful activities, and guided laughter exercises.

This design allows within-subject comparison of outcomes before and after the intervention. The goal is to assess the effects of laughter yoga on sexual functioning and psychological well-being in individuals with multiple sclerosis.

Intervention: Laughter Yoga (Other)

Outcomes

Primary Outcomes

Change in Sexual Functioning (MSISQ-19 Total Score)

Time Frame: Baseline (Week 0), Pre-Intervention (Week 5), and Post-Intervention (Week 11)

Sexual functioning will be assessed using the Multiple Sclerosis Intimacy and Sexuality Questionnaire-19 (MSISQ-19). This scale includes 19 items measuring primary, secondary, and tertiary sexual dysfunctions in individuals with MS. Scores range from 19 to 95, with higher scores indicating greater dysfunction. A reduction in score reflects improvement in sexual functioning.

Secondary Outcomes

  • Change in Anxiety Level (HADS-A Score)(Baseline (Week 0), Pre-Intervention (Week 5), and Post-Intervention (Week 11))
  • Change in Fatigue Level (Fatigue Severity Scale Score)(Baseline (Week 0), Pre-Intervention (Week 5), and Post-Intervention (Week 11))

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Cansu POLAT DÜNYA

PhD, Assistant Professor

Istanbul University

Study Sites (1)

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