About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Diagnosed with Beta Thalassaemia major,
Over 18 years of age,
No hearing and communication problems,
The one with the smartphone
Disqualifiers
Who doesn't practice laughter yoga
Changing the treatment regime
Patients who wish to withdraw from the study
Trial design
Parallel
Treatments tested in this trial
laughter yoga
Other interventionLaughter 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Depression-Anxiety-Stress Scale (DASS-42)
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)
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.
Sponsors and contacts
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