The Effect of Laughter Yoga on Symptom Severity, Depression-anxiety-stress, Sleep Quality and Quality of Life in Patients with Irritable Bowel Syndrome

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.

• Depression-Anxiety-Stress Scale (DASS-42) [Срок оценки: DASS-42 will be evaluated 2 times in total, at baseline and week 4.]
• Pittsburg Sleep Quality Index (PSQI) [Срок оценки: PSQI will be evaluated 2 times in total, at baseline and week 4.]
• Irritable Bowel Syndrome Quality of Life Scale (IBSQOL) [Срок оценки: The IBS-QOL scale will be evaluated 2 times in total, at baseline and week 4.]