- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07524231
Evaluation of the Effects of Laughter Yoga
Evaluation of the Effects of Laughter Yoga on Pain Intensity, Stress, and Beta-endorphin Levels in Patients With Multiple Sclerosis
Study Overview
Detailed Description
Multiple Sclerosis (MS) is a chronic, autoimmune, and demyelinating disease that generally affects the central nervous system in young adults. Multiple Sclerosis is a highly heterogeneous disease, with a wide range of clinical signs and symptoms depending on the area of the central nervous system affected, including motor, sensory, autonomic, and cognitive impairments. Multiple Sclerosis is associated with a broad spectrum of bodily dysfunctions, including motor problems such as muscle weakness, changes in muscle tone, ataxia, abnormal balance, and sensory disturbances. In addition, fatigue, pain, bladder and bowel dysfunction, cognitive and emotional problems, vision problems, speech and swallowing disorders, and sexual dysfunction also affect individuals with MS. Currently, there are 2.5 million MS patients worldwide, and the cost of treatment and care for these patients is quite high.
In addition to medical treatment, traditional and complementary medicine (TCM) methods are used in the treatment of pain and fatigue. Laughter Yoga, a type of yoga that has begun to be applied as a TCM method, was developed by Indian physician Dr. Developed by Madan Kataria in 1995, each laughter yoga session consists of breathing exercises, stretching and relaxation techniques, and laughter exercises. Physiologically, laughter yoga has been reported to increase breathing, relax muscles, stimulate circulation and the immune system, increase endorphin release, thereby increasing pain threshold and tolerance, reduce fatigue, decrease stress hormone levels, strengthen mental function, reduce depression and anxiety, improve sleep quality, and enhance interpersonal relationships and social interaction, thus improving psychological well-being. This research was planned as a randomized controlled experimental study to evaluate the effects of laughter yoga applied to Multiple Sclerosis patients on pain intensity, fatigue, and Beta Endorphin levels.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Gül DURAL, pHD
- Phone Number: 04242370000
- Email: gulkaya@firat.edu.tr
Study Locations
-
-
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Elâzığ, Turkey (Türkiye)
- Recruiting
- Gül DURAL
-
Contact:
- Gül DURAL, pHD
- Phone Number: 04242370000
- Email: gulkaya@firat.edu.tr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
• Being over 18 years old
- Being able to communicate adequately
- Volunteering to participate in the research
Exclusion Criteria:
- Unwillingness to participate in the study
Having severe cognitive impairment that prevents understanding or participation in the intervention
Having a psychiatric disorder that may affect participation in the study
Experiencing an acute MS relapse during the study period
Having another serious neurological or chronic disease that may affect the study outcomes
Regular participation in another complementary therapy program similar to laughter yoga
Communication problems that prevent participation in the intervention sessions
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental Group
Patients with Multiple Sclerosis who will receive laughter yoga in addition to routine care.
|
A complementary intervention including breathing exercises, stretching, relaxation techniques, and laughter exercises applied to patients with Multiple Sclerosis.
|
|
No Intervention: Control Group
Patients with Multiple Sclerosis who will receive routine care without laughter yoga.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in pain intensity measured by Visual Analog Scale (VAS) at [time point]
Time Frame: Baseline and week 4
|
Pain intensity will be assessed using the Visual Analog Scale (VAS), a 10 cm scale ranging from 0 (no pain) to 10 (worst imaginable pain).
Participants will indicate their pain level by marking on the scale, and the score will be determined by measuring the distance in centimeters or millimeters.
|
Baseline and week 4
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fatigue Level
Time Frame: 1 month
|
Fatigue severity will be assessed using the Fatigue Severity Scale (FSS), a 9-item questionnaire evaluating fatigue over the past month.
Each item is scored on a scale of 0 to 7, with higher scores indicating greater fatigue severity.
The Turkish validity and reliability study was conducted by Armutlu et al. in 2007.
A change of 0.45 points is considered clinically meaningful.
|
1 month
|
|
Change in plasma beta-endorphin levels measured by ELISA at baseline and week 4
Time Frame: Baseline and week 4
|
Plasma beta-endorphin levels will be measured using an ELISA method.
Blood samples will be collected from participants in the intervention group before and after laughter yoga sessions at week 1 and week 4, and from the control group at week 1 and week 4. Samples will be centrifuged, and serum will be stored at -80°C until analysis.
Beta-endorphin concentrations will be determined using a commercially available ELISA kit.
|
Baseline and week 4
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Nervous System Diseases
- Autoimmune Diseases
- Immune System Diseases
- Demyelinating Autoimmune Diseases, CNS
- Autoimmune Diseases of the Nervous System
- Demyelinating Diseases
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Pain
- Multiple Sclerosis
- Fatigue
- Therapeutics
- Mind-Body Therapies
- Complementary Therapies
- Laughter Therapy
Other Study ID Numbers
- 2024/15-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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