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

NCT06705153 | Recruiting

• 1 other identifier: AtaturkU-EBALA-01
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Irritable Bowel Syndrome

Keywords

Irritable Bowel Syndrome; Laughter Yoga; stress; depression; Anxiety; quality of life; symptom severity; sleep quality

Outcome Measures

Primary Outcomes (1)

• 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.

  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)

  DASS-42 will be evaluated 2 times in total, at baseline and week 4.

• Pittsburg Sleep Quality Index (PSQI)

  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 evaluated 2 times in total, at baseline and week 4.

Study Arms (2)

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".

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.

Interventions

laughter yoga OTHER

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 group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Gender Eligibility Details: female and male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ataturk University: lead

Study Sites (1)

Erzurum City Hospital

Erzurum, Yakutiye, 25070, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Irritable Bowel Syndrome; Depression; Anxiety Disorders; Sleep Initiation and Maintenance Disorders

Interventions

Laughter Therapy

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Behavioral Symptoms; Behavior; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics

Central Study Contacts

Ebru BALA

CONTACT

+905313854141; ebrubala23@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: November 22, 2024
• First Posted: November 26, 2024
• Study Start: December 4, 2024
• Primary Completion: January 28, 2025
• Study Completion: February 28, 2025
• Last Updated: January 3, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share

Locations

TU (1)