NCT07128264

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2025

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 12, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 17, 2025

Completed
12 days until next milestone

Study Start

First participant enrolled

August 29, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

August 17, 2025

Status Verified

August 1, 2025

Enrollment Period

7 months

First QC Date

August 12, 2025

Last Update Submit

August 13, 2025

Conditions

Keywords

Ankylosing spondylitis(AS),Nursing,Pain,Depression/anxiety/stress,Laughter yoga

Outcome Measures

Primary Outcomes (1)

  • Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)

    BASDAI, which assesses disease activity in ankylosing spondylitis, was developed by Garret and colleagues in 1994 . The scale includes six questions to assess disease activity over the past week, consisting of fatigue, spinal pain, joint swelling, tenderness, and morning stiffness. The patient's symptoms are scored on a scale of 0 to 10 (0 = none, 10 = very severe). When calculating the total score, the average of questions 5 and 6 is added to the scores of questions 1, 2, 3, and 4, and the total is divided by 5 to determine the total score. The total score of the scale ranges from 0 to 10. Higher scores indicate greater disease activity.

    6 weeks

Secondary Outcomes (4)

  • Pain Scale (Visual Analog Scale)

    6 weeks

  • Bath Ankylosing Spondylitis Functional Index (BASFI)

    6 weeks

  • DASS-42 Scale (Depression-Anxiety-Stress Scale)

    6 weeks

  • Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL)

    6 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

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.

Behavioral: Laughter Yoga

Control

NO INTERVENTION

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

Interventions

Laughter YogaBEHAVIORAL

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Spondylitis, Ankylosing

Interventions

Laughter Therapy

Condition Hierarchy (Ancestors)

Axial SpondyloarthritisSpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesAnkylosisJoint DiseasesArthritis

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeutics

Study Officials

  • Emine KIYAK, Prof.Dr.

    Ataturk University

    STUDY DIRECTOR

Central Study Contacts

Selanay UNAL, Graduate student

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Two groups with a laughter yoga control group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 12, 2025

First Posted

August 17, 2025

Study Start

August 29, 2025

Primary Completion

April 1, 2026

Study Completion

April 1, 2026

Last Updated

August 17, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share