Relaxation Exercise and Education in Patients With Irritable Bowel Syndrome

NCT06690762 | Not Yet Recruiting

• 1 other identifier: MAUN-HEM-MC-01
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

Irritable bowel syndrome (IBS) is a common functional gastrointestinal disorder characterized by chronic recurrent abdominal pain, bloating, changes in bowel habits or bowel movements (1-3). Pharmacological and nonpharmacological methods are used in the treatment of IBS. In addition to lifestyle changes such as dietary changes, physical activity, and stress reduction, relaxation techniques, herbal medicines, and nutritional supplements are important nonpharmacological methods used by IBS patients. Progressive muscle relaxation exercises (PGE) have been reported to positively affect IBS symptoms, patients' quality of life, anxiety, and depression. PGE training in patients with IBS has been found to improve general health perception, reduce symptom severity, and healthcare costs. (7-9). PGE is a complementary treatment and is among advanced nursing practices (10, 11). In this study, a mobile application will be developed to educate patients about IBS and PGE. It is thought that this application will reduce the severity of patients' symptoms and increase their quality of life. This study is planned to determine the effects of mobile technology-based training combined with relaxation exercises on stress, symptom severity and quality of life in patients with irritable bowel syndrome.

Conditions

Irritable Bowel Disease

Keywords

Irritable Bowel Syndrome, Stress, Symptom Severity, Quality of Life, Relaxation

Outcome Measures

Primary Outcomes (3)

• Perceived Stress Scale

  The Perceived Stress Scale (PSS) consists of a total of 14 items. PSS is designed to measure how stressful a person perceives certain situations in their life. Each item is evaluated on a 5-point Likert-type scale ranging from "Never (0)" to "Very often (4)". The 7 items with positive expressions are scored reversely (items 4, 5, 6, 7, 9, 10, and 13). PSS-14 scores range from 0 to 56. A high score indicates a high perception of stress.

  three months

• IBS symptom severity score

  The IBS symptom severity score (IBS-SSS) was developed to assess the severity of symptoms in IBS. The scale is widely used to monitor the progression and treatment of the disease. The IBS-SSS assesses the severity and duration of abdominal pain (abdominal pain, painful days), abdominal bloating (bloating), satisfaction with bowel habits (bowel habits), and quality of life. The scale consists of a total of 5 questions, each with a score ranging from 0 to 100. The total score of the scale ranges from 0 to 500, with higher scores indicating increased severity of the disease. Scores between 0-74 on the scale are classified as remission, 75-174 as mild, 175-299 as moderate, and 300 and above as severe IBS.

  three months

• Irritable Bowel Syndrome Quality of Life

  Irritable Bowel Syndrome Quality of Life (IBS QOL) Scale The Irritable Bowel Syndrome Quality of Life (IBS-QOL) Scale was developed to assess the quality of life in patients with Irritable Bowel Syndrome. The 5-point Likert-type scale prepared for IBS patients consists of 34 items and 8 sub-dimensions; The sub-dimensions are mood, activity, body image, health, food avoidance, social response, sexuality and social relationship. The raw scores obtained are evaluated by converting them out of 100 using the formula \[Transformed score = (Scale raw score - number of items / maximum possible score - minimum possible score) x 100\]. The sub-dimension and total scores of the IBS-QOL scale vary between 0-100. Increasing scale scores indicate that the health-related quality of life of individuals increases.

  three months

Study Arms (2)

Education

EXPERIMENTAL

It consists of nutrition, physical activity, stress management, relaxation exercises and defecation training.

Other: Education

Kontrol

NO INTERVENTION

no intervention

Interventions

Education OTHER

It consists of nutrition, physical activity, stress management, relaxation exercises and defecation training.

Education

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age and older, applied to the polyclinic where the study was conducted,
• Have been diagnosed with IBS according to Rome IV criteria,
• Have a smart phone or computer,
• Have no illness that would prevent them from doing progressive muscle relaxation exercises (heart failure, chronic obstructive pulmonary disease, asthma, pregnant, etc.),

You may not qualify if:

• Having communication problems

Sponsors & Collaborators

• Muş Alparslan University: lead

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Central Study Contacts

Ömer faruk altunç, professor

CONTACT

+904362494949; o.altunc@alparslan.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2024
• First Posted: November 15, 2024
• Study Start: December 2, 2024
• Primary Completion: December 6, 2024
• Study Completion: July 22, 2025
• Last Updated: November 15, 2024

Record last verified: 2024-11