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Starting soon Not applicable

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

NCT06980662 · tracked via the Priya Life Science Turkey tracker
Phase
Not applicable
Started
2025-06-01
Last updated
2025-05-20

Condition(s) studied

Beta Thalassemia MajorThalassemia Majors (Beta-Thalassemia Major)

Investigational drug(s) / intervention(s)

laughter yoga

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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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 outcome measure(s)

  • 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.

Trial sites (1)

FacilityCityRegionStatus
Batman Training and Research Hospital Batman Turkey (Türkiye)
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06980662 on ClinicalTrials.gov ↗ ← All trials in Turkey