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

NCT ID: NCT06980662

Last Updated: 2025-05-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-01
• Study Completion Date: 2025-08-31

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

Conditions

Beta Thalassemia Major; Thalassemia Majors (Beta-Thalassemia Major)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention Group

This group of patients will receive laughter yoga. Laughter yoga is a type of complementary therapy that also includes some other components, including light physical exercises. This type of therapy combines unconditional laughter with yoga breathing exercises and yoga stretches, enabling patients to laugh in a different way from jokes or humour programmes. Patients in the intervention group will be divided into 2 groups of 15 patients 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. Together with the patients participating in the study, the days of the laughter yoga programme will be decided to be suitable for the patients.

Group Type: EXPERIMENTAL

laughter yoga

Intervention Type: OTHER

Laughter yoga is a type of complementary therapy that also includes some other components, including light physical exercises. This type of therapy combines unconditional laughter with yoga breathing exercises and yoga stretching positions, enabling patients to laugh in a different way from jokes or humour programmes. Laughter yoga steps; Warm-up exercises (5-10 minutes), Deep breathing exercises (10 minutes), Childish games (10 minutes), Laughter exercises (15 minutes). During laughter yoga, laughter is achieved without any jokes, comedy or humour and supports the realisation of a sincere laughter that does not involve cognitive thinking in individuals. Laughter yoga sessions should be done at home in a quiet and calm environment by making eye contact. Laughter yoga is applied in sessions that include warm-up, breathing and laughing exercises accompanied by applause and songs. The sessions take place in groups and last 45 minutes.

Control Group

Laughter yoga will not be applied to patients in this group. Pre- and post-tests will be taken and observed for 6 weeks. During this period, all patients will continue to receive their routine treatment.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

laughter yoga

Laughter yoga is a type of complementary therapy that also includes some other components, including light physical exercises. This type of therapy combines unconditional laughter with yoga breathing exercises and yoga stretching positions, enabling patients to laugh in a different way from jokes or humour programmes. Laughter yoga steps; Warm-up exercises (5-10 minutes), Deep breathing exercises (10 minutes), Childish games (10 minutes), Laughter exercises (15 minutes). During laughter yoga, laughter is achieved without any jokes, comedy or humour and supports the realisation of a sincere laughter that does not involve cognitive thinking in individuals. Laughter yoga sessions should be done at home in a quiet and calm environment by making eye contact. Laughter yoga is applied in sessions that include warm-up, breathing and laughing exercises accompanied by applause and songs. The sessions take place in groups and last 45 minutes.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ataturk University

OTHER

Sponsor Role: lead

Responsible Party

Zeynep Bozan

STUDENT

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Emine Kıyak, Professor

Role: STUDY_DIRECTOR

Ataturk University

Locations

Batman Training and Research Hospital

Batman, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Central Contacts

Zeynep Bozan

Role: CONTACT

Zynbbzn72@gmail.com

+905076899114

Emine Kıyak, Professor

Role: CONTACT

frtemine@hotmail.com

+905065567540

Study Documents

Document Type: Clinical Study Report

The Effect of Happiness Training on Psychological Well-Being in Patients with Thalassaemia Major: A quasi-experimental study

View Document

Related Links

https://pubmed.ncbi.nlm.nih.gov/37383528/

Thalassemia is an inherited blood disorder affecting hemoglobin synthesis which leads to chronic hemolysis

https://pubmed.ncbi.nlm.nih.gov/36072082/

Thalassaemia is a common inherited haematological disease. Thalassaemia major (TM) is characterised by either the lack of or reduced production of globin chains.

Other Identifiers

AU-SBE-ZB-01

Identifier Type: -

Identifier Source: org_study_id