The Effect of Laughter Yoga on Patients With Ankylosing Spondylitis: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Patients who do not participate in laughter yoga
- •Patients who wish to withdraw from the study
研究组 & 干预措施
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.
干预措施: Laughter Yoga (Behavioral)
Control
Laughter yoga will not be applied to patients in the control group.
结局指标
主要结局
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
时间窗: 6 weeks
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.
次要结局
- DASS-42 Scale (Depression-Anxiety-Stress Scale)(6 weeks)
- Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL)(6 weeks)
- Pain Scale (Visual Analog Scale)(6 weeks)
- Bath Ankylosing Spondylitis Functional Index (BASFI)(6 weeks)
研究者
SELANAY ÜNAL
Principal Investigator
Ataturk University