Effect of Stress Ball on Irritable Bowel Syndrome

NCT05931107 | Completed

• 1 other identifier: Cansutez
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

Objective: This study will be conducted to evaluate the effect of stress ball on symptom severity, quality of life, depression, anxiety and stress in patients with irritable bowel syndrome (IBS). Material and Method: The data of the randomized controlled experimental study will be collected at the gastroenterology outpatient clinic of Erzurum City Hospital. A simple randomization list was created with the Random Allocation Software program and it will be carried out with a total of 56 patients diagnosed with IBS, including 28 experimental and 28 control groups. Patients in the experimental group were asked to squeeze the stress ball for at least 10 minutes every day for 4 weeks. No treatment will be applied to those in the control group. Patient information form, IBS symptom severity score, IBS quality of life scale, Depression-Anxiety-Stress scale will be used to collect research data. Keywords: Irritable Bowel Syndrome, patient, stress ball, Depression, Anxiety, Stress, Quality of Life

Conditions

Irritable Bowel Syndrome; Quality of Life; Depression; Anxiety; Stress

Keywords

Irritable Bowel Syndrome; patient; stress ball; Depression; Anxiety; Stress; Quality of Life

Outcome Measures

Primary Outcomes (1)

• Irritable Bowel Syndrome Symptom Severity Score,

  The IBS symptom severity score 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 habit), and quality of life. The scale consists of a total of 5 questions, each ranging from 0 to 100 points. The total score of the scale ranges from 0 to 500, and high scores indicate an increase in disease severity. In the scale, 0-74 points are classified as remission, 75-174 as mild, 175-299 as moderate, 300 points and above as severe severe IBS.

  Four weeks

Secondary Outcomes (2)

• Irritable Bowel Syndrome Quality of Life Scale

  Four weeks

• Depression-Anxiety-Stress Scale

  Four weeks

Study Arms (2)

Stress ball practice group (Stress ball squeezing)

EXPERIMENTAL

Patient information form, IBS symptom severity score, IBS quality of life scale and Depression-Anxiety-Stress scale will be administered by the researcher using face-to-face interview technique (pre-test) to the patients in both groups.The patients in the experimental group will be told how to use the stress ball in the room in the outpatient clinic and each patient will be given a stress ball. The first sessions of the patients will be held together with the patient in the outpatient clinic. Patients will apply a stress ball (squeezing the stress ball) once a day at home. In order to ensure the continuity of the stress ball application, the phone numbers of the patients will be taken and a reminder message will be sent every day. The patients' IBS symptom severity score will be evaluated every week.The experimental group has to squeeze the stress ball for 10-15 minutes every day for 4 weeks.

Other: Stress ball practice group (Stress ball squeezing)

Control group

NO INTERVENTION

Patients who come to the outpatient clinic will be met, information will be given about the research, and consent will be obtained from the patients who agree to participate in the research. The groups of the patients who meet the inclusion criteria will be determined according to the randomization list. Patient information form, IBS symptom severity score, IBS quality of life scale and Depression-Anxiety-Stress scale will be administered by the researcher using face-to-face interview technique (pre-test) to the patients in both groups. Stress ball attempts will not be made to the patients in the control group. Phone numbers of patients in this group will be taken. Patients' IBS symptom severity score will be evaluated every week. Patients in both groups will continue to use routine treatments for 4 weeks. After the research is completed, the patients in the control group will be given a stress ball according to their wishes and will be informed about its application.

Interventions

Stress ball practice group (Stress ball squeezing) OTHER

The stress ball is made of round, colorful, high-quality silicone. A stress ball of medium hardness and 6 cm in diameter (suitable for adult use) will be used in the research. When it is loosened, it returns to its original state. In the experimental group, the patients are required to squeeze the ball once after counting to three, inhale each time they squeeze the ball, exhale when they loosen their grip, and focus only on the ball. The experimental group has to squeeze the stress ball for 10-15 minutes every day for 4 weeks.

Stress ball practice group (Stress ball squeezing)

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with IBS according to Rome IV criteria,
• A score of 75 or higher (not in remission) on the IBS symptom severity score,
• Scoring 9 and below for depression (without depression), 7 and below for anxiety (without anxiety), and 14 and below for stress (without stress) on the Depression-Anxiety-Stress scale.
• are ≥18 years of age,
• Having no physical problems (any fracture, open wound and lack of muscle strength in the hand, wrist and arm) for squeezing the stress ball,
• No problem in communicating,
• IBS patients who accepted to participate in the study will be included in the study.

You may not qualify if:

• A score of 74 or less (in remission) on the IBS symptom severity score.
• A score of 9 and below for depression (without depression), 7 and below for anxiety (without anxiety), and 14 and below for stress (without stress) on the Depression-Anxiety-Stress scale.
• Having any physical disability (any fracture, open wound and lack of muscle strength in the hand, wrist and arm) to squeeze the stress ball,
• Patients who have problems communicating,
• Patients who wish to withdraw from the study will be excluded from the study.

Sponsors & Collaborators

• Bedriye Cansu DEMİRKIRAN: lead

Study Sites (1)

Erzurum City Hospital

Erzurum, 25070, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Ataturk University

  Ataturk University Faculty of Nursing / Erzurum

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: June 27, 2023
• First Posted: July 5, 2023
• Study Start: July 19, 2023
• Primary Completion: September 12, 2023
• Study Completion: October 9, 2023
• Last Updated: July 31, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)