Clinical Trials Directory

Trials / Not Yet Recruiting

Not Yet RecruitingNCT07128264

The Effect of Laughter Yoga on Patients With Ankylosing Spondylitis

The Effect of Laughter Yoga on Patients With Ankylosing Spondylitis: A Randomized Controlled Trial

Status
Not Yet Recruiting
Phase
N/A
Study type
Interventional
Enrollment
60 (estimated)
Sponsor
Ataturk University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

This study will be conducted to evaluate the effects of laughter yoga on disease activity, pain, functional status, depression/anxiety/stress, and quality of life in ankylosing spondylitis patients.

Detailed description

Ankylosing spondylitis is a common inflammatory rheumatic disease that primarily affects the axial skeleton, causes characteristic inflammatory back pain, and can lead to progressive structural and functional impairments and a decrease in quality of life. The main symptoms of the disease include severe back pain and spinal stiffness, as well as inflammation of the peripheral joints, hips, and fingers/toes. In advanced cases, inflammation of the spinal joints may lead to fusion of the spine and associated functional limitations. Research has shown that physical symptoms in AS patients are accompanied by psychological symptoms such as fatigue, stress, depression, and anxiety. All of these factors can lead to a deterioration in quality of life. Material and Method: This randomized controlled trial will be conducted with a total of 60 patients (30 intervention and 30 control) who agreed to participate in the study and visited the Rheumatology Outpatient Clinic at Erzurum City Hospital. Patients in the intervention group will undergo laughter yoga sessions twice a week for 45 minutes over a period of 6 weeks. Patient information forms will be used to collect research data, and the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) will be used as the primary measurement tool. Secondary measurement tools will include the Visual Analogue Scale (VAS) Pain Scale, Bath Ankylosing Spondylitis Functional Index (BASFI), Depression/Anxiety/Stress Scale (DASS-42), and Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL). Application of the research: Patients visiting the outpatient clinic will be informed about the study, and written consent will be obtained from patients who agree to participate in the study. Inclusion criteria for the study will be evaluated. Patients will be administered the patient information form, Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Visual Analogue Scale (VAS), Bath Ankylosing Spondylitis Functional Index (BASFI), DASS-42, and Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL) scales. Patients will be assigned to the intervention and control groups according to the randomization list. Intervention group: The researcher will provide general information about laughter yoga to each patient in the intervention group, and the Microsoft Teams application will be installed on the patients' smartphones for the laughter yoga sessions. Patients' phone numbers will be collected for communication, and WhatsApp groups will be created to facilitate communication. The days of the laughter yoga program will be decided in consultation with the patients participating in the study, taking into account the patients' schedules. Prior to laughter yoga, each patient in the intervention group will receive an informational message about the meeting, and patients' attendance at the sessions will be monitored using a tracking chart. Patients in the intervention group will be divided into two groups of 15. The intervention group will undergo a total of 12 laughter yoga sessions over 6 weeks, with two 45-minute sessions per week via Microsoft Teams. Laughter yoga sessions will be held every week on ………. and ………. days. Laughter yoga will not be applied to patients in the control group. At the end of the 6th week, patients in both groups will come to the rheumatology outpatient clinic and final test measurements will be taken. At the outpatient clinic, patients will be administered the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Vas Pain Scale, Bath Ankylosing Spondylitis Functional Index (BASFI), Depression/Anxiety/Stress Scale (DASS-42), and Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL) will be administered to patients at the outpatient clinic. For patients in the intervention group, final test measurements will be conducted at least two days after the session to exclude the acute effects of laughter yoga. Patients in both the intervention and control groups will continue their routine treatments for six weeks.

Conditions

Interventions

TypeNameDescription
BEHAVIORALLaughter YogaLaughter eliminates feelings such as hopelessness, anger, and anxiety, thereby alleviating stress, depression, and anxiety, raising the pain threshold, reducing stress, accelerating blood circulation, strengthening immunity, improving quality of life, strengthening memory, reducing tension, and relaxing muscles. Based on these positive effects, laughter yoga is a complementary treatment method that combines humor and laughter. Laughter yoga sessions will be conducted online via Microsoft Teams in a quiet and peaceful environment at home. The first 10-minute section consists of warm-up exercises (warming up and clapping). The second 10-minute section consists of deep breathing exercises that prepare the lungs for laughter. The third 10-minute section consists of childlike games that induce laughter without humor. The fourth and final 15-minute section consists of laughter exercises that enable laughter without any jokes, comedy, or humor.

Timeline

Start date
2025-08-29
Primary completion
2026-04-01
Completion
2026-04-01
First posted
2025-08-17
Last updated
2025-08-17

Source: ClinicalTrials.gov record NCT07128264. Inclusion in this directory is not an endorsement.