The Effect of Laughter Yoga in Beta Thalassaemia Major Patients: a Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- The Chronic Disease Therapy-Functional Assessment of Fatigue (FACIT-Fatigue) Scale
研究概览
简要总结
The aim of this study was to evaluate the effects of laughter yoga on Fatigue, Depression-Anxiety-Stress, Sleep quality, Haematological values and Blood transfusion number in Beta Thalassemia Major patients.
详细描述
Beta Thalassaemia Major patients require regular transfusions at an early age due to severe anaemia. These frequent blood transfusions, which are necessary to manage anaemia in Beta Thalassaemia Major patients, cause iron overload, a major complication associated with the management of Beta Thalassaemia Major. Proximal symptoms in patients with Beta Thalassaemia Major include fatigue followed by pain, shortness of breath, palpitations, dizziness and weakness. Distal symptoms include mobility problems, sleep problems and difficulty concentrating. Mental problems such as depression and stress are also common in Beta Thalassaemia Major patients.
Material and Method: This randomised controlled study will be conducted in a total of 60 patients (30 intervention and 30 control) with the diagnosis of Beta Thalassemia Major in the Thalassemia Unit of Batman Training and Research Hospital. Patients in the intervention group will practice laughter yoga for 45 minutes 2 days a week for 6 weeks. Patient information form, Facit-Fatigue scale as primary measurement tool, Depression-Anxiety-Stress scale as secondary measurement tool, Pittsburgh sleep quality scale, haematological values of the patient and number of blood transfusions will be used to collect research data.
Implementation of the Research: Patients will be met in the thalassaemia unit and informed about the study and written consent will be obtained from patients who agree to participate in the study. The status of potential patients meeting the inclusion criteria will be determined. Depression-Anxiety-Stress Scale (DASS-42) will be applied.
Patients who fulfil the inclusion criteria will be numbered according to the order of the interview. FACIT-fatigue, Pittsburgh sleep quality scale and patient information form will be applied to the patients. Haematological values (haemoglobin, haematocrit, serum iron, serum ferritin, MCV and MCH values) and the number of erythrocyte transfusions of each patient will be obtained from the information system.
Patients will be assigned to intervention and control groups according to the randomisation list.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with Beta Thalassaemia major,
- •Over 18 years of age,
- •No hearing and communication problems,
- •The one with the smartphone
- •Routine treatment with iron chelators, folic acid and magnesium
- •Do not have a physical problem that will prevent yoga exercises (bleeding haemorrhoids, all kinds of hernia, persistent cough, incontinence, severe back pain, hypertension, major psychiatric diseases, pregnancy, flu, epilepsy, surgery in the last 3 months, etc.)
- •Depression-Anxiety-Stress scale scores of 10 and above for depression (depressed), 8 and above for anxiety (anxious), 15 and above for stress (stressed)
- •Beta thalassaemia major patients who volunteered to participate in the study will be included in the study sample
排除标准
- •Who doesn't practice laughter yoga
- •Changing the treatment regime
- •Patients who wish to withdraw from the study
结局指标
主要结局
The Chronic Disease Therapy-Functional Assessment of Fatigue (FACIT-Fatigue) Scale
时间窗: 6 week
The FACIT-Fatigue Scale will be used as the primary outcome measure. The Chronic Disease Therapy-Functional Assessment of Fatigue (FACIT-Fatigue) Scale is an old measure of fatigue based on classical test theory. The FACIT-Fatigue Scale consists of 13 statements measuring the fatigue experienced by patients in the last seven days. The statements in the scale consist of a Likert-type questionnaire scored between 0 and 4 and consist of 'Not at all', 'A little', 'A little', 'Quite a bit', 'Quite a lot' and 'Very much' options. The total score range of your scale is 0-52. The higher the scale score, the lower the patient's level of fatigue and vice versa. Items 1, 2, 3, 4, 4, 5, 6, 6, 9, 10, 11, 12, 13 in the scale are reverse scored, while items 7 and 8 are scored normally. It is reported that perceived fatigue is clinically severe if the score obtained from the scale is 30 and below. FACIT-F will be evaluated 2 times in total, at the beginning and at the end of the 6th week.
次要结局
- Depression-Anxiety-Stress Scale (DASS-42)(6 week)
- Pittsburgh Sleep Quality Scale (PSQS)(6 week)