Clinical trial NCT06705153: The Effect of Laughter Yoga on Symptom Severity, Depression-anxiety-stress, Sleep Quality and Quality of Life in Patients with Irritable Bowel Syndrome
Official title: The Effect of Laughter Yoga in Patients with Irritable Bowel Syndrome: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Irritable Bowel Syndrome
Keywords: Irritable Bowel Syndrome
Laughter Yoga
stress
depression
Anxiety
quality of life
symptom severity
sleep quality
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2024-11-26
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

Brief 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. 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: 1. 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: IBS Symptom Severity Score - (IBS-SSS)
timeFrame: IBS-SSS will be assessed 5 times in total, at baseline and weeks 1, 2, 3 and 4.
Secondary outcomes:
measure: Depression-Anxiety-Stress Scale (DASS-42)
timeFrame: DASS-42 will be evaluated 2 times in total, at baseline and week 4.
measure: Pittsburg Sleep Quality Index (PSQI)
timeFrame: PSQI will be evaluated 2 times in total, at baseline and week 4.
measure: Irritable Bowel Syndrome Quality of Life Scale (IBSQOL)
timeFrame: The IBS-QOL scale will be evaluated 2 times in total, at baseline and week 4.
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: Erzurum City Hospital
state: Yakutiye
Study officials:
References: