The Effect of Laughter Yoga on Patients With Ankylosing Spondylitis

NCT ID: NCT07128264

Last Updated: 2025-08-17

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-29
• Study Completion Date: 2026-04-30

Brief 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

Ankylosing Spondylitis (AS)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention

Patients in the intervention group will be divided into 2 groups of 15 people. A total of 12 sessions of laughter yoga will be applied to the intervention group in the form of meetings via the Microsoft teams application, in 45-minute sessions 2 times a week for 6 weeks. Laughter yoga sessions will be held every week on ………. and ………. days. The days of the laughter yoga program will be decided in accordance with the patients, together with the participating patients, on the basis of research. Before the laughter yoga, an informative message will be sent to each patient in the intervention group about the meeting and the patients' participation in the sessions will be checked with a follow-up chart.

Group Type: EXPERIMENTAL

Laughter Yoga

Intervention Type: BEHAVIORAL

Laughter 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.

Control

Laughter yoga will not be applied to patients in the control group.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Laughter Yoga

Laughter 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Those diagnosed with ankylosing spondylitis,
• Those who scored 10 or above on the depression scale, 8 or above on the anxiety scale, and 15 or above on the stress scale of the Depression-Anxiety-Stress Scale
• Are over 18 years of age,
• Have no hearing or communication problems,
• Possess a smartphone,
• Have no physical problems that would prevent them from performing yoga exercises (bleeding hemorrhoids, any type of hernia, persistent cough, incontinence, hypertension, major psychiatric disorders, pregnancy, flu, epilepsy, or surgery within the last 3 months, etc.)
• Ankylosing spondylitis patients who volunteer to participate in the study will be included in the study sample.

Exclusion Criteria

• Patients who do not participate in laughter yoga
• Patients who wish to withdraw from the study

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ataturk University

OTHER

Sponsor Role: lead

Responsible Party

SELANAY ÜNAL

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Emine KIYAK, Prof.Dr.

Role: STUDY_DIRECTOR

Ataturk University

Central Contacts

Selanay UNAL, Graduate student

Role: CONTACT

selenayunal65@gmail.com

+905315011736

Other Identifiers

AU-SBE-SU-01

Identifier Type: -

Identifier Source: org_study_id