Clinical trial NCT06947434: Laughter Yoga for Improving Sexual Function and Psychosocial Outcomes in Multiple Sclerosis
Official title: Effects of Laughter Yoga on Sexual Functioning, Anxiety, Depression, Fatigue, and Quality of Life in Patients With Multiple Sclerosis: A Quasi-Experimental Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Sexual Dysfunction
Keywords: multiple sclerosis
sexual life
anxiety
depression
quality of life
laughter yoga
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2025-04-27
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This study utilizes a single-group pretest-posttest quasi-experimental design to evaluate the effects of a structured laughter yoga intervention on psychological symptoms (anxiety and depression), fatigue, sexual life, and quality of life in individuals with multiple sclerosis (MS). The model includes three data collection points: baseline (Week 0), five weeks after the pretest (Week 5, without intervention), and post-intervention (Week 11, after 10 laughter yoga sessions). This within-subject design allows for the comparison of participant outcomes over time, enabling the assessment of changes attributable to the intervention. No control group is included in this design.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Sexual Functioning (MSISQ-19 Total Score)
timeFrame: Baseline (Week 0), Pre-Intervention (Week 5), and Post-Intervention (Week 11)
Secondary outcomes:
measure: Change in Anxiety Level (HADS-A Score)
timeFrame: Baseline (Week 0), Pre-Intervention (Week 5), and Post-Intervention (Week 11)
measure: Change in Fatigue Level (Fatigue Severity Scale Score)
timeFrame: Baseline (Week 0), Pre-Intervention (Week 5), and Post-Intervention (Week 11)
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University School Of Nursing
Study officials:
References: