Clinical trial NCT06980662: The Effect of Laughter Yoga in Beta Thalassaemia Major Patients: a Randomised Controlled Trial
Official title: The Effect of Laughter Yoga in Beta Thalassaemia Major Patients: a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Beta Thalassemia Major
Thalassemia Majors (Beta-Thalassemia Major)
Keywords: Nursing, Fatigue, Depression-Anxiety-Stress and Sleep quality
fatigue
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2025-05-20
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups with a laughter yoga therapy control group.
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: The Chronic Disease Therapy-Functional Assessment of Fatigue (FACIT-Fatigue) Scale
timeFrame: 6 week
Secondary outcomes:
measure: Depression-Anxiety-Stress Scale (DASS-42)
timeFrame: 6 week
measure: Pittsburgh Sleep Quality Scale (PSQS)
timeFrame: 6 week
Other outcomes:
Locations:
city: Batman
country: Turkey
facility: Batman Training and Research Hospital
Study officials:
affiliation: Ataturk University
name: Emine Kıyak, Professor
role: STUDY_DIRECTOR
References: