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Clinical Trials in Turkey / NCT06705153
Recruiting Not applicable

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

NCT06705153 · tracked via the Priya Life Science Turkey tracker
Sponsor
Ataturk University
Phase
Not applicable
Started
2024-12-04
Last updated
2025-01-03

Condition(s) studied

Irritable Bowel Syndrome

Investigational drug(s) / intervention(s)

laughter yoga

laughter yoga: 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 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
90 Years
Healthy volunteers
No
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 outcome measure(s)

  • IBS Symptom Severity Score - (IBS-SSS) — 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.

Trial sites (1)

FacilityCityRegionStatus
Erzurum City Hospital Erzurum Yakutiye Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06705153 on ClinicalTrials.gov ↗ ← All trials in Turkey