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

NCT06980662 | Not Yet Recruiting DMC

• 1 other identifier: AU-SBE-ZB-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Nursing, Fatigue, Depression-Anxiety-Stress and Sleep quality; fatigue

Outcome Measures

Primary Outcomes (1)

• The Chronic Disease Therapy-Functional Assessment of Fatigue (FACIT-Fatigue) Scale

  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.

  6 week

Secondary Outcomes (2)

• Depression-Anxiety-Stress Scale (DASS-42)

  6 week

• Pittsburgh Sleep Quality Scale (PSQS)

  6 week

Study Arms (2)

Intervention Group

EXPERIMENTAL

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.

Other: laughter yoga

Control Group

NO INTERVENTION

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.

Interventions

laughter yoga 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.

Intervention Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Ataturk University: lead

Study Sites (1)

Batman Training and Research Hospital

Batman, 72000, Turkey (Türkiye)

Location

Related Links

• Thalassemia is an inherited blood disorder affecting hemoglobin synthesis which leads to chronic hemolysis
• Thalassaemia is a common inherited haematological disease. Thalassaemia major (TM) is characterised by either the lack of or reduced production of globin chains.

MeSH Terms

Conditions

beta-Thalassemia; Fatigue; Sleep Initiation and Maintenance Disorders

Interventions

Laughter Therapy

Condition Hierarchy (Ancestors)

Thalassemia; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics

Study Officials

• Emine Kıyak, Professor

  Ataturk University

  STUDY DIRECTOR

Central Study Contacts

Zeynep Bozan

CONTACT

+905076899114; Zynbbzn72@gmail.com

Emine Kıyak, Professor

CONTACT

+905065567540; frtemine@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: STUDENT

Model Details: Two groups with a laughter yoga therapy control group.

Study Record Dates

• First Submitted: May 12, 2025
• First Posted: May 20, 2025
• Study Start: June 1, 2025
• Primary Completion: August 31, 2025
• Study Completion: August 31, 2025
• Last Updated: May 20, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)