The Effect of Laughter Yoga in Beta Thalassaemia Major Patients: a Randomised Controlled Trial

Not Applicable

Not yet recruiting

• Conditions: Beta Thalassemia Major; Thalassemia Majors (Beta-Thalassemia Major)

• Registration Number: NCT06980662
• Lead Sponsor: Ataturk University

Brief Summary

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.

Detailed Description

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.

The primary researcher will give general information about laughter yoga to each patient in the intervention group and Skype application will be installed on the patients' smartphones for the meeting where laughter yoga sessions will be held. The phone numbers of the patients will be taken for communication, the researcher will give the number to the patients and WhatsAap groups will be created to facilitate communication. Before the laughter yoga, an information message will be sent to each patient in the intervention group and the attendance of the patients to the sessions will be checked with a follow-up chart.

Patients in the intervention group will be divided into 2 groups of 15 people each. A total of 12 sessions of laughter yoga will be applied to the intervention group for 6 weeks in the form of meetings via Skype application in the form of 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 programme will be decided together with the patients participating in the study, as appropriate for the patients.

At the end of the 6th week, patients in both groups will come to the thalassaemia unit. In the unit, FACIT-fatigue, Depression-Anxiety-Stress and Pittsburg sleep quality scale will be applied to the patients and haematological values and number of erythrocyte transfusions will be taken from the information system of the hospital (post-test measurements). Patients in the intervention group will be performed at least 2 days after the session to exclude the acute effect of laughter yoga.

Patients in both groups will continue to use routine treatments for 6 weeks

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-12
• Study First Submitted QC: 2025-05-12
• Last Update Submitted: 2025-05-12
• Study First Posted: 2025-05-20
• Last Update Posted: 2025-05-20
• Study Start: 2025-06-01
• Primary Completion: 2025-08-31
• Study Completion: 2025-08-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• 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

Exclusion Criteria

• Who doesn't practice laughter yoga
• Changing the treatment regime
• Patients who wish to withdraw from the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The Chronic Disease Therapy-Functional Assessment of Fatigue (FACIT-Fatigue) Scale	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.

Secondary Outcome Measures

Name	Time	Method
Depression-Anxiety-Stress Scale (DASS-42)	6 week	The scale is 4-point Likert type and consists of 3 sub-dimensions (depression, anxiety, stress). Each sub-dimension has 14 items and there are 42 items in total in the scale. Depression items (3, 5, 10, 13, 16, 17, 21, 21, 24, 26, 31, 34, 37, 38, 42) evaluate helplessness, worthlessness, discontent, loss of interest and low energy level. Anxiety items (2, 4, 7, 9, 15, 15, 19, 20, 23, 25, 28, 30, 36, 40, 41) measure the level of muscle response, autonomic arousal, subjective and situational anxiety. Stress items (1, 6, 8, 11, 12, 14, 18, 22, 27, 29, 32, 33, 35, 39) assess the level of discomfort, difficulty relaxing, overreacting, nervous arousal, intolerance, easy upset and boredom. Depression is divided into 5 categories as remission (0-9), mild (10-13), moderate (14-20), advanced (21-27) and very advanced (28-42); anxiety remission (0-7), mild (8-9), moderate (10-14), advanced (15-19) and very advanced (20-42) and stress remission (0-14), mild (15-18), moderate (19-25), advanced (26
Pittsburgh Sleep Quality Scale (PSQS)	6 week	The scale includes 24 questions. Nineteen of these questions are self-assessment questions. Five questions are answered by the spouse or a friend of the individual. These five questions are used for clinical information and are not included in the scoring. Self-assessment questions include different factors related to sleep quality.; The 18 scored items were grouped into 7 component scores. Some of the components consist of a single item, while others are obtained by grouping several items. Each item is evaluated with a score between 0 and 3.

Trial Locations

Locations (1)

Batman Training and Research Hospital; 🇹🇷 Batman, Turkey