Multiple SclerosisNCT06947434
Laughter Yoga for Improving Sexual Function and Psychosocial Outcomes in Multiple Sclerosis
A study testing Laughter Yoga in people with Multiple Sclerosis and Sexual Dysfunction, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis, Sexual Dysfunction
- What is being tested?
- Laughter Yoga
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2022to 1 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University School Of Nursing
Istanbul, 34116
About this study
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
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
Read the 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.
- Conditions
- Multiple Sclerosis, Sexual Dysfunction
- Being tested
- Laughter Yoga
- Keywords
- multiple sclerosis, sexual life, anxiety, depression, quality of life, laughter yoga
- Medical subject headings
- Multiple Sclerosis, Sexual Dysfunction, Physiological, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laughter YogaOther
Laughter yoga is a behavioral intervention that combines intentional laughter exercises with yogic breathing techniques. In this study, the intervention consisted of 10 sessions delivered over five weeks (two sessions per week), each lasting approximately 40 minutes. Sessions were conducted live via Zoom and included components such as rhythmic clapping, deep breathing (pranayama), playful movements, and guided laughter exercises. The aim was to promote relaxation, reduce stress, and enhance psychological well-being in individuals with multiple sclerosis.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Laughter Yoga |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Sexual Functioning (MSISQ-19 Total Score)
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.
Measured: Baseline (Week 0), Pre-Intervention (Week 5), and Post-Intervention (Week 11)
Secondary outcomes (2)
Change in Anxiety Level (HADS-A Score)
Anxiety levels will be measured using the Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A). Scores range from 0 to 21, with higher scores indicating greater anxiety. A decrease in the score reflects improvement.
Measured: Baseline (Week 0), Pre-Intervention (Week 5), and Post-Intervention (Week 11)
Change in Fatigue Level (Fatigue Severity Scale Score)
Fatigue will be assessed using the Fatigue Severity Scale (FSS), consisting of 9 items rated on a scale from 1 (strongly disagree) to 7 (strongly agree). Higher scores indicate greater fatigue. A mean score ≥4 indicates clinically significant fatigue.
Measured: Baseline (Week 0), Pre-Intervention (Week 5), and Post-Intervention (Week 11)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2025
- Study start1 Mar 2022
- Primary completion1 Mar 2023
- Study completion1 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cansu POLAT DÜNYA, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06947434
- Sponsor's protocol ID
- 2022/352
- Status last verified
- Apr 2025
- First submitted
- 20 Apr 2025
- Last updated
- 30 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06947434
- Acronym / sponsor ID
- 2022/352
- Conditions
- Multiple Sclerosis, Sexual Dysfunction
- Keywords
- multiple sclerosis, sexual life, anxiety, depression, quality of life, laughter yoga
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 27 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Other: Laughter YogaParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laughter YogaLaughter yoga is a behavioral intervention that combines intentional laughter exercises with yogic breathing techniques. In this study, the intervention consisted of 10 sessions delivered over five weeks (two sessions per week), each lasting approximately 40 minutes. Sessions were conducted live via Zoom and included components such as rhythmic clapping, deep breathing (pranayama), playful movements, and guided laughter exercises. The aim was to promote relaxation, reduce stress, and enhance psychological well-being in individuals with multiple sclerosis. | Other | Single Arm |
Primary outcome
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.
2 secondary outcomes
Change in Anxiety Level (HADS-A Score)
Time frame: Baseline (Week 0), Pre-Intervention (Week 5), and Post-Intervention (Week 11)
Change in Fatigue Level (Fatigue Severity Scale Score)
Time frame: Baseline (Week 0), Pre-Intervention (Week 5), and Post-Intervention (Week 11)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2025.
- Individual participant dataSharing planned: No
Related trials for Multiple Sclerosis
RecruitingPhase 2
Metformin as an add-on or Monotherapy in Treatment of Aging People With Multiple Sclerosis (MS)
Multiple Sclerosis
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
RecruitingPhase 3
Dalfampridine Combined With Physical Therapy for Mobility Impairment in Multiple Sclerosis
Multiple Sclerosis
RecruitingPhase 2
Targeting Agonists of Glucagon-like Peptide-1 Receptor for Multiple Sclerosis
Multiple Sclerosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laughter Yoga in people with Multiple Sclerosis and Sexual Dysfunction, run by Istanbul University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Sexual Functioning (MSISQ-19 Total Score) (time frame: Baseline (Week 0), Pre-Intervention (Week 5), and Post-Intervention (Week 11)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2025.