Beta Thalassemia MajorNCT06980662
The Effect of Laughter Yoga in Beta Thalassaemia Major Patients: a Randomised Controlled Trial
A study testing laughter yoga in people with Beta Thalassemia Major and Thalassemia Majors (Beta-Thalassemia Major), run by Ataturk University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Beta Thalassemia Major, Thalassemia Majors (Beta-Thalassemia Major)
- What is being tested?
- laughter yoga
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2025to 31 Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Who doesn't practice laughter yoga
- Changing the treatment regime
- Patients who wish to withdraw from the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Batman Training and Research Hospital
Batman, 72000
About this study
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.
Read the 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
- Being tested
- laughter yoga
- Keywords
- Nursing, Fatigue, Depression-Anxiety-Stress and Sleep quality, fatigue
- Medical subject headings
- beta-Thalassemia, Fatigue, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laughter yogaOther
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 week
Secondary outcomes (2)
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
Measured: 6 week
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.
Measured: 6 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2025
- Study start1 Jun 2025 (estimated)
- Primary completion31 Aug 2025 (estimated)
- Study completion31 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Beta Thalassemia MajorStudies of the same condition, open and under way.
- More trials run by Ataturk UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two groups with a laughter yoga therapy control group.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeynep Bozan, Ataturk University
- Investigators
- Emine Kıyak, Professor, Study director, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06980662
- Sponsor's protocol ID
- AU-SBE-ZB-01
- Status last verified
- May 2025
- First submitted
- 12 May 2025
- Last updated
- 20 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: I want my work data to remain private
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Laughter Yoga in Beta Thalassaemia Major Patients: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06980662
- Acronym / sponsor ID
- AU-SBE-ZB-01
- Keywords
- Nursing, Fatigue, Depression-Anxiety-Stress and Sleep quality, fatigue
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 20 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two groups with a laughter yoga therapy control group.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: laughter yogaThis 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. |
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (3 listed)
- Who doesn't practice laughter yoga
- Changing the treatment regime
- Patients who wish to withdraw from the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| laughter yogaLaughter 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. | Other | Intervention Group |
Primary outcome
The Chronic Disease Therapy-Functional Assessment of Fatigue (FACIT-Fatigue) Scale
Time frame: 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.
2 secondary outcomes
Depression-Anxiety-Stress Scale (DASS-42)
Time frame: 6 week
Pittsburgh Sleep Quality Scale (PSQS)
Time frame: 6 week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2025.
- Thalassemia is an inherited blood disorder affecting hemoglobin synthesis which leads to chronic hemolysisLink provided by the sponsor.
- Thalassaemia is a common inherited haematological disease. Thalassaemia major (TM) is characterised by either the lack of or reduced production of globin chains.Link provided by the sponsor.
- Individual participant dataSharing planned: No. I want my work data to remain private
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Emine Kıyak, Professor study director
Ataturk University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing laughter yoga in people with Beta Thalassemia Major and Thalassemia Majors (Beta-Thalassemia Major), run by Ataturk University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zeynep Bozan (+905076899114, Zynbbzn72@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Chronic Disease Therapy-Functional Assessment of Fatigue (FACIT-Fatigue) Scale (time frame: 6 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2025.