Irritable Bowel SyndromeNCT06705153
The Effect of Laughter Yoga on Symptom Severity, Depression-anxiety-stress, Sleep Quality and Quality of Life in Patients with Irritable Bowel Syndrome
A study testing laughter yoga in people with Irritable Bowel Syndrome, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
The study will be conducted to evaluate the effect of laughter yoga on symptom severity, depression, anxiety, stress, sleep and quality of life in patients with Irritable Bowel Syndrome (IBS). The following hypotheses will be tested in this study: H1: Laughter yoga reduces symptom severity in patients with IBS. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- laughter yoga
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Dec 2024to 28 Feb 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with IBS according to Rome IV criteria,
- Scoring 75 and above on the IBS-SSS score,
- DASS-42 scores of 10 and above for depression, 8 and above for anxiety, 15 and above for stress,
- Over 18 years of age,
- Bleeding hemorrhoids, all types of hernia, persistent cough, severe back pain, heart diseases, high blood pressure, urinary incontinence, major psychiatric diseases, pregnancy, cold/flu, no epilepsy, no surgery in the last three months, etc.
- Patients with a smartphone/computer where it is possible to participate in a video call for laughter yoga,
- Patients without communication problems and
- Patients who agree to participate in the study will be included in the study.
Who cannot join
- who do not practice laughter yoga,
- who do not attend regularly,
- Patients whose treatment regimen has changed and
- Patients who wish to leave the study will be excluded 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, 1 recruiting
- Recruiting
Erzurum City Hospital
Erzurum, Yakutiye, 25070
Ebru BALA, Hemşire, +905313854141, ebrubala23@gmail.com
About this study
Official title: The Effect of Laughter Yoga in Patients with Irritable Bowel Syndrome: a Randomized Controlled Trial
The study will be conducted to evaluate the effect of laughter yoga on symptom severity, depression, anxiety, stress, sleep and quality of life in patients with Irritable Bowel Syndrome (IBS).
The following hypotheses will be tested in this study:
H1: Laughter yoga reduces symptom severity in patients with IBS. H2: Laughter yoga reduces depression, anxiety and stress in patients with IBS. H3: Laughter yoga improves sleep quality in patients with IBS. H4: Laughter yoga improves quality of life in patients with IBS.
Read the detailed description
- Materials and Methods
1.1. Study design and participants This randomized controlled study will be conducted to evaluate the effect of laughter yoga in patients with IBS who come to Erzurum City Hospital gastroenterology outpatient clinic. Patient information form, IBS symptom severity score (IBS-SSS), Depression, Anxiety and Stress Scale (DASS-42), Pittsburg Sleep Quality Index (PSQI) and IBS quality of life scale (IBS-QOL) will be applied to the patients. The patients in the intervention group will have laughter yoga for 2 sessions per week (total 8 sessions) for 4 weeks and the patients in the control group will not have laughter yoga. Patients in both groups will be evaluated for IBS-SSS at baseline and at the end of weeks 1, 2, 3 and 4. Patients in both groups will be administered DASS-42, PSQI and IBS-QOL at baseline and at the end of the 4th week. This work will be conducted in accordance with CONSORT guidelines.
1.2. Sample size and randomization A priori power analysis was calculated in the G. Power 3.1. program to determine the estimated sample size. IBS symptom severity score, the primary measurement tool, was used in power analysis. The sample size was calculated as 50 between two different groups (control group and intervention group) and five measurements (baseline, weeks 1, 2, 3, and 4) with an effect size of Cohen's f = 0.25 (medium effect), power of the test (1-β)=0.95 and α=0.05. Considering the possible losses, 10% drop out was added to the calculated sample and the sample size was calculated as 28 in the intervention group and 28 in the control group, totaling 56.
Patients coming to the outpatient clinic between November-2024 and January-2025 will be determined whether they meet the inclusion criteria. A total of 56 patients will form a sample pool. Potential patients will be numbered in order of arrival at the outpatient clinic. Following the creation of the sample pool, the Random Allocation Software 1.0 program will be used to ensure homogeneous distribution of participants to the groups. In this program, a randomization list will be created with a simple randomization method. In this randomization list, there is a numbered random distribution of 56 participants, 28 in the intervention group and 28 in the control group. Potential participants in the sample pool will be allocated to groups according to the numbers given. 56 patients will be distributed as 28 in the intervention group and 28 in the control group.
1.3. Intervention Patients who come to the outpatient clinic will be met, informed about the study and written informed consent will be obtained from patients who agree to participate in the study. Patient information form will be applied, baseline measurements will be made (IBS-SSS, DAS-42, PSQI and IBS-QOL) and IBS type will be determined according to Bristol stool scale. Type 1-2 constipation, Type 6-7 diarrhea, Type 1 or Type 2 at the same time with Type 6 or Type 7 will be considered as mixed type IBS and those who do not fit any of the scales will be considered as unclassifiable IBS. A total of 8 sessions will be held with the patients in the intervention group in the form of meetings via zoom with the help of a smart cell phone/computer (2 weekly sessions). The meetings will be in 3 groups.
Laughter yoga is a four-part program that lasts about 40 minutes and is led by a leader. These are deep breathing exercises (5-10 minutes), clapping and warm-up exercises (10 minutes), childlike games (10 minutes) and laughter exercises (15 minutes). The philosophy of laughter yoga, a non-invasive and non-pharmacological therapy method that includes breathing techniques that combine unconditional laughter with relaxation and breathing exercises, is based on the statement "movement creates emotion".
Patients in the control group will not receive laughter yoga and will use their routine treatment. At the end of the 1st, 2nd, 3rd and 4th week, IBS-SSS of the patients in the intervention and control groups will be evaluated and at the end of the 4th week, DASS-42, PSQI and IBS-QOL scale will be applied to the patients in both groups.
1.4. Measurement Tools Patient information form, IBS-SSS as the primary measurement tool, DASS-42, PSQI and IBS-QOL scale as secondary measurement tools will be used to collect the data of the study.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- laughter yoga
- Keywords
- Irritable Bowel Syndrome, Laughter Yoga, stress, depression, Anxiety, quality of life, symptom severity, sleep quality
- Medical subject headings
- Irritable Bowel Syndrome, Depression, Anxiety Disorders, 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
Patients who come to the outpatient clinic will be met, informed about the study and written informed consent will be obtained from patients who agree to participate in the study. Patient information form will be applied, baseline measurements will be made (IBS-SSS, DAS-42, PSQI and IBS-QOL) and IBS type will be determined according to Bristol stool scale. Type 1-2 constipation, Type 6-7 diarrhea, Type 1 or Type 2 at the same time with Type 6 or Type 7 will be considered as mixed type IBS and those who do not fit any of the scales will be considered as unclassifiable IBS. A total of 8 sessions will be held with the patients in the intervention group in the form of meetings via zoom with the help of a smart cell phone/computer (2 weekly sessions). The meetings will be in 3 groups.
| Study group | Role | What they receive |
|---|---|---|
| laughter yoga group | Experimental | The patients in the intervention group will have laughter yoga for 2 sessions per week (total 8 sessions) for 4 weeks in the form of meetings via zoom with the help of a smart cell phone/computer and the patients in the control group will not have laughter yoga. Patients in both groups will be evaluated for IBS-SSS at baseline and at the end of weeks 1, 2, 3 and 4. Patients in both groups will be administered DASS-42, PSQI and IBS-QOL at baseline and at the end of the 4th week. Laughter yoga is a four-part program that lasts about 40 minutes and is led by a leader. These are deep breathing exercises (5-10 minutes), clapping and warm-up exercises (10 minutes), childlike games (10 minutes) and laughter exercises (15 minutes). The philosophy of laughter yoga, a non-invasive and non-pharmacological therapy method that includes breathing techniques that combine unconditional laughter with relaxation and breathing exercises, is based on the statement "movement creates emotion". Receives: Other: laughter yoga |
| control group | No intervention | Patients in the control group will not receive laughter yoga and will use their routine treatment. Patients in both groups will be evaluated for IBS-SSS at baseline and at the end of weeks 1, 2, 3 and 4. Patients in both groups will be administered DASS-42, PSQI and IBS-QOL at baseline and at the end of the 4th week. |
What is being measured
The primary outcome is the main question the study is designed to answer.
IBS Symptom Severity Score - (IBS-SSS)
The IBS-SSS will be used as the primary measurement tool. The scale is used to assess the course of the disease and the treatment process. The IBS-SSS assesses the severity and duration of abdominal pain, complaints of abdominal bloating, distension, fullness and gas, satisfaction with bowel habits and how bowel symptoms affect a person's life. Each of the scale items consists of a total of 5 questions ranging from 0 to 100 points. The scale score ranges from 0 to 500, with higher scores indicating increased symptom severity. In the scale, 0-74 points are classified as remission, 75-174 as mild, 175-299 as moderate, and 300 points and above as severe severe IBS. The assessment states that a 50-point reduction is sufficient for clinical improvement. The IBS-SSS was chosen as the primary measurement tool because it is effective in evaluating the course of IBS and the effectiveness of treatment and is widely used.
Measured: IBS-SSS will be assessed 5 times in total, at baseline and weeks 1, 2, 3 and 4.
Secondary outcomes (3)
Depression-Anxiety-Stress Scale (DASS-42)
Secondary measuring instrument: DASS-42 will be used. The scale is 4-point Likert-type and consists of 3 sub-dimensions (depression, anxiety, stress). Each sub-dimension has 14 items and the scale has 42 items in total. Each of the depression, anxiety and stress scores ranged from 0 to 42, with depression, anxiety and stress increasing as the score increased. Depression was 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 (26-33) and very advanced (34-42).
Measured: DASS-42 will be evaluated 2 times in total, at baseline and week 4.
Pittsburg Sleep Quality Index (PSQI)
Secondary measurement tool: PSQI will be used. The scale consists of 24 questions. 19 of the questions were self-assessment questions. Five questions are answered by the individual's spouse or a friend. These five questions are used for clinical information and are not included in the scoring. Self-assessment questions include various factors related to sleep quality. The 18 scored items were grouped into 7 component scores. Some of the components consist of a single substance, while others are obtained by grouping several substances. Each item is evaluated with a score between 0-3.The scores of the 7 components of the scale are calculated and summed to obtain a total scale score. A high total scale score indicates poor sleep quality. The scale indicates the presence or absence of sleep disorders or the prevalence of sleep disorders. A PSQI total scale score of 5 and above indicates poor sleep quality.
Measured: PSQI will be evaluated 2 times in total, at baseline and week 4.
Irritable Bowel Syndrome Quality of Life Scale (IBSQOL)
The IBS-QOL scale will be used as the other secondary measurement tool. The scale prepared for IBS patients is 5-point Likert-type and consists of a total of 34 items and 8 sub-dimensions. Scale sub-dimensions are dysphoria, activity, body image, health anxiety, food avoidance, social reaction, sexual and social relationship. The total score of the scale is obtained by summing the scores obtained from 34 items, and the sub-dimension scores are obtained by summing each of the sub-dimensions separately. The sub-dimension and total scores of the IBS-QOL scale range between 0-100. Higher scale scores indicate a decreased quality of life.
Measured: The IBS-QOL scale will be evaluated 2 times in total, at baseline and week 4.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2024
- Study start4 Dec 2024
- Primary completion28 Jan 2025 (estimated)
- Study completion28 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel SyndromeStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This randomized controlled study will be conducted to evaluate the effect of laughter yoga in patients with IBS who come to Erzurum City Hospital gastroenterology outpatient clinic. Patient information form, IBS symptom severity score (IBS-SSS), Depression, Anxiety and Stress Scale (DASS-42), Pittsburg Sleep Quality Index (PSQI) and IBS quality of life scale (IBS-QOL) will be applied to the patients. The patients in the intervention group will have laughter yoga for 2 sessions per week (total 8 sessions) for 4 weeks and the patients in the control group will not have laughter yoga. Patients in both groups will be evaluated for IBS-SSS at baseline and at the end of weeks 1, 2, 3 and 4. Patients in both groups will be administered DASS-42, PSQI and IBS-QOL at baseline and at the end of the 4th week.
- Masking
- None (open label)
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ebru BALA, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06705153
- Sponsor's protocol ID
- AtaturkU-EBALA-01
- Status last verified
- Nov 2024
- First submitted
- 22 Nov 2024
- Last updated
- 3 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Laughter Yoga in Patients with Irritable Bowel Syndrome: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06705153
- Acronym / sponsor ID
- AtaturkU-EBALA-01
- Conditions
- Irritable Bowel Syndrome
- Keywords
- Irritable Bowel Syndrome, Laughter Yoga, stress, depression, Anxiety, quality of life, symptom severity, sleep quality
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 4 Dec 2024 (actual)
- Primary completion
- 28 Jan 2025 (estimated)
- Study completion
- 28 Feb 2025 (estimated)
- First posted
- 26 Nov 2024 (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 study will be conducted to evaluate the effect of laughter yoga on symptom severity, depression, anxiety, stress, sleep and quality of life in patients with Irritable Bowel Syndrome (IBS).
The following hypotheses will be tested in this study:
H1: Laughter yoga reduces symptom severity in patients with IBS. H2: Laughter yoga reduces depression, anxiety and stress in patients with IBS. H3: Laughter yoga improves sleep quality in patients with IBS. H4: Laughter yoga improves quality of life in patients with IBS.
Detailed description
- Materials and Methods
1.1. Study design and participants This randomized controlled study will be conducted to evaluate the effect of laughter yoga in patients with IBS who come to Erzurum City Hospital gastroenterology outpatient clinic. Patient information form, IBS symptom severity score (IBS-SSS), Depression, Anxiety and Stress Scale (DASS-42), Pittsburg Sleep Quality Index (PSQI) and IBS quality of life scale (IBS-QOL) will be applied to the patients. The patients in the intervention group will have laughter yoga for 2 sessions per week (total 8 sessions) for 4 weeks and the patients in the control group will not have laughter yoga. Patients in both groups will be evaluated for IBS-SSS at baseline and at the end of weeks 1, 2, 3 and 4. Patients in both groups will be administered DASS-42, PSQI and IBS-QOL at baseline and at the end of the 4th week. This work will be conducted in accordance with CONSORT guidelines.
1.2. Sample size and randomization A priori power analysis was calculated in the G. Power 3.1. program to determine the estimated sample size. IBS symptom severity score, the primary measurement tool, was used in power analysis. The sample size was calculated as 50 between two different groups (control group and intervention group) and five measurements (baseline, weeks 1, 2, 3, and 4) with an effect size of Cohen's f = 0.25 (medium effect), power of the test (1-β)=0.95 and α=0.05. Considering the possible losses, 10% drop out was added to the calculated sample and the sample size was calculated as 28 in the intervention group and 28 in the control group, totaling 56.
Patients coming to the outpatient clinic between November-2024 and January-2025 will be determined whether they meet the inclusion criteria. A total of 56 patients will form a sample pool. Potential patients will be numbered in order of arrival at the outpatient clinic. Following the creation of the sample pool, the Random Allocation Software 1.0 program will be used to ensure homogeneous distribution of participants to the groups. In this program, a randomization list will be created with a simple randomization method. In this randomization list, there is a numbered random distribution of 56 participants, 28 in the intervention group and 28 in the control group. Potential participants in the sample pool will be allocated to groups according to the numbers given. 56 patients will be distributed as 28 in the intervention group and 28 in the control group.
1.3. Intervention Patients who come to the outpatient clinic will be met, informed about the study and written informed consent will be obtained from patients who agree to participate in the study. Patient information form will be applied, baseline measurements will be made (IBS-SSS, DAS-42, PSQI and IBS-QOL) and IBS type will be determined according to Bristol stool scale. Type 1-2 constipation, Type 6-7 diarrhea, Type 1 or Type 2 at the same time with Type 6 or Type 7 will be considered as mixed type IBS and those who do not fit any of the scales will be considered as unclassifiable IBS. A total of 8 sessions will be held with the patients in the intervention group in the form of meetings via zoom with the help of a smart cell phone/computer (2 weekly sessions). The meetings will be in 3 groups.
Laughter yoga is a four-part program that lasts about 40 minutes and is led by a leader. These are deep breathing exercises (5-10 minutes), clapping and warm-up exercises (10 minutes), childlike games (10 minutes) and laughter exercises (15 minutes). The philosophy of laughter yoga, a non-invasive and non-pharmacological therapy method that includes breathing techniques that combine unconditional laughter with relaxation and breathing exercises, is based on the statement "movement creates emotion".
Patients in the control group will not receive laughter yoga and will use their routine treatment. At the end of the 1st, 2nd, 3rd and 4th week, IBS-SSS of the patients in the intervention and control groups will be evaluated and at the end of the 4th week, DASS-42, PSQI and IBS-QOL scale will be applied to the patients in both groups.
1.4. Measurement Tools Patient information form, IBS-SSS as the primary measurement tool, DASS-42, PSQI and IBS-QOL scale as secondary measurement tools will be used to collect the data of the study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This randomized controlled study will be conducted to evaluate the effect of laughter yoga in patients with IBS who come to Erzurum City Hospital gastroenterology outpatient clinic. Patient information form, IBS symptom severity score (IBS-SSS), Depression, Anxiety and Stress Scale (DASS-42), Pittsburg Sleep Quality Index (PSQI) and IBS quality of life scale (IBS-QOL) will be applied to the patients. The patients in the intervention group will have laughter yoga for 2 sessions per week (total 8 sessions) for 4 weeks and the patients in the control group will not have laughter yoga. Patients in both groups will be evaluated for IBS-SSS at baseline and at the end of weeks 1, 2, 3 and 4. Patients in both groups will be administered DASS-42, PSQI and IBS-QOL at baseline and at the end of the 4th week.
| Arm | Type | Receives |
|---|---|---|
| laughter yoga group | Experimental | Other: laughter yogaThe patients in the intervention group will have laughter yoga for 2 sessions per week (total 8 sessions) for 4 weeks in the form of meetings via zoom with the help of a smart cell phone/computer and the patients in the control group will not have laughter yoga. Patients in both groups will be evaluated for IBS-SSS at baseline and at the end of weeks 1, 2, 3 and 4. Patients in both groups will be administered DASS-42, PSQI and IBS-QOL at baseline and at the end of the 4th week. Laughter yoga is a four-part program that lasts about 40 minutes and is led by a leader. These are deep breathing exercises (5-10 minutes), clapping and warm-up exercises (10 minutes), childlike games (10 minutes) and laughter exercises (15 minutes). The philosophy of laughter yoga, a non-invasive and non-pharmacological therapy method that includes breathing techniques that combine unconditional laughter with relaxation and breathing exercises, is based on the statement "movement creates emotion". |
| control group | No intervention | –Patients in the control group will not receive laughter yoga and will use their routine treatment. Patients in both groups will be evaluated for IBS-SSS at baseline and at the end of weeks 1, 2, 3 and 4. Patients in both groups will be administered DASS-42, PSQI and IBS-QOL at baseline and at the end of the 4th week. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Diagnosed with IBS according to Rome IV criteria,
- Scoring 75 and above on the IBS-SSS score,
- DASS-42 scores of 10 and above for depression, 8 and above for anxiety, 15 and above for stress,
- Over 18 years of age,
- Bleeding hemorrhoids, all types of hernia, persistent cough, severe back pain, heart diseases, high blood pressure, urinary incontinence, major psychiatric diseases, pregnancy, cold/flu, no epilepsy, no surgery in the last three months, etc.
Key exclusion criteria (4 listed)
- who do not practice laughter yoga,
- who do not attend regularly,
- Patients whose treatment regimen has changed and
- Patients who wish to leave the study will be excluded 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 yogaPatients who come to the outpatient clinic will be met, informed about the study and written informed consent will be obtained from patients who agree to participate in the study. Patient information form will be applied, baseline measurements will be made (IBS-SSS, DAS-42, PSQI and IBS-QOL) and IBS type will be determined according to Bristol stool scale. Type 1-2 constipation, Type 6-7 diarrhea, Type 1 or Type 2 at the same time with Type 6 or Type 7 will be considered as mixed type IBS and those who do not fit any of the scales will be considered as unclassifiable IBS. A total of 8 sessions will be held with the patients in the intervention group in the form of meetings via zoom with the help of a smart cell phone/computer (2 weekly sessions). The meetings will be in 3 groups. | Other | laughter yoga group |
Primary outcome
IBS Symptom Severity Score - (IBS-SSS)
Time frame: IBS-SSS will be assessed 5 times in total, at baseline and weeks 1, 2, 3 and 4.
The IBS-SSS will be used as the primary measurement tool. The scale is used to assess the course of the disease and the treatment process. The IBS-SSS assesses the severity and duration of abdominal pain, complaints of abdominal bloating, distension, fullness and gas, satisfaction with bowel habits and how bowel symptoms affect a person's life. Each of the scale items consists of a total of 5 questions ranging from 0 to 100 points. The scale score ranges from 0 to 500, with higher scores indicating increased symptom severity. In the scale, 0-74 points are classified as remission, 75-174 as mild, 175-299 as moderate, and 300 points and above as severe severe IBS. The assessment states that a 50-point reduction is sufficient for clinical improvement. The IBS-SSS was chosen as the primary measurement tool because it is effective in evaluating the course of IBS and the effectiveness of treatment and is widely used.
3 secondary outcomes
Depression-Anxiety-Stress Scale (DASS-42)
Time frame: DASS-42 will be evaluated 2 times in total, at baseline and week 4.
Pittsburg Sleep Quality Index (PSQI)
Time frame: PSQI will be evaluated 2 times in total, at baseline and week 4.
Irritable Bowel Syndrome Quality of Life Scale (IBSQOL)
Time frame: The IBS-QOL scale will be evaluated 2 times in total, at baseline and week 4.
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 3 Jan 2025.
- Individual participant dataSharing planned: Yes
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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.
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 Irritable Bowel Syndrome, 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 4 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: looking for participants now, as of the sponsor's last update on 3 Jan 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 Ebru BALA (+905313854141, ebrubala23@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IBS Symptom Severity Score - (IBS-SSS) (time frame: IBS-SSS will be assessed 5 times in total, at baseline and weeks 1, 2, 3 and 4.). 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 3 Jan 2025.