Effect of Stress Ball on Irritable Bowel Syndrome

Study Overview
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Brief Summary
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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 research will be carried out with 60 IBS patients diagnosed according to the Rome IV criteria, coming to the gastroenterology outpatient clinic of Erzurum City Hospital. Patients will be distributed to the experimental and control groups according to the randomization list prepared with the Random Allocation Software program. The patients in the experimental group will squeeze the stress ball for 10-15 minutes every day for 1 month. Stress ball application will not be applied to the patients in the control group. Patient information form, Irritable Bowel Syndrome Symptom Severity Score, Irritable Bowel Syndrome Quality of Life Scale and Depression-Anxiety-Stress Scale will be used to collect data. Chi-square test will be used in comparison of patient characteristics according to groups, t test will be used in independent groups for those with normal distribution, and Mann Whitney U test will be used for those without normal distribution. In the comparison of normally distributed data between groups, t-test will be used in independent groups and Mann-Whitney U test will be used in those that do not show normal distribution. In the comparison of normally distributed data within groups, the t-test will be used in dependent groups, and the Wilcoxon test will be used in data that do not show normal distribution. Keywords: Irritable Bowel Syndrome, patient, stress ball, Depression, Anxiety, Stress, Quality of Life

Detailed Description
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Irritable bowel syndrome (IBS) is a chronic biopsychosocial disorder characterized by recurrent abdominal pain, constipation and/or diarrhea, bloating, flatulence, and urgent defecation.The diagnosis of IBS is made using the Rome IV criteria. With the emergence of IBS symptoms, individuals' daily lives, work, sleep patterns, leisure time, eating habits, travels, sexual and social relationships are adversely affected. It is stated that anxiety and depression exacerbate IBS symptoms, impair quality of life, increase health service seeking behaviors, and increase health care use and costs. 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). 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. The patients in the experimental group will be given information on how to use the stress ball in the room in the outpatient clinic and a stress ball will be given to each patient. 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. 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. 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. A 4-week program will be created and patients will be asked to mark the program they apply every day and the program will be checked by calling the patients every week and their general status will be asked. Stress ball attempts will not be made to the patients in the control group. The patients in this group will be called once a week to get their phone numbers and ask about their status. Patients in both groups will be called to the outpatient clinic at the end of the 4th week. IBS symptom severity score, IBS quality of life scale and Depression-Anxiety-Stress scale will be applied to the patients in the outpatient clinic (post test). 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.

Official Title
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Evaluation of the Effect of Stress Ball in Patients With Irritable Bowel Syndrome

Conditions
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Irritable Bowel Syndrome, Quality of Life, Depression, Anxiety, Stress

Intervention / Treatment
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* Other: Stress ball practice group (Stress ball squeezing)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stress ball practice group (Stress ball squeezing)<br>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 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)<br>* 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.<br>|
| No Intervention: Control group<br>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. The patients in this group will be called once a week to get their phone numbers and ask about their status. 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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Irritable Bowel Syndrome Quality of Life Scale | Patrick et al. It was created by IBS to evaluate the quality of life in patients with IBS. In this scale, which was prepared for patients with irritable bowel syndrome, there are 5 Likert-type response options (1: Never, 2: Some, 3: Moderate, 4: A lot, 5: A lot). The scale consists of 8 sub-dimensions and 34 items; Sub-dimensions; dysphoria, activity , body image , health concern, food avoidance, social reaction , sexual and social relationship. Scores from each sub-dimension are calculated in itself. The overall score of the scale is determined by the total scores obtained from 34 items. The raw scores obtained from the scale sub-dimension and its total range between 34-170. Higher scale scores indicate that individuals' quality of life increases. The validity and reliability study in our country was carried out by Özgürsoy Uran et al. | Four weeks | 
| Depression-Anxiety-Stress Scale | The Turkish validity and reliability study of the scale developed by Lovibond and Lovibond was carried out by Bilgel and Bayram. The scale was a 4-point Likert scale type. The scale consists of 3 sub-dimensions (depression, anxiety, stress). Each sub-dimension consists of 14 items and there are 42 items in total. Depression items measure dissatisfaction, helplessness, worthlessness, loss of interest and low energy level. Anxiety items assess the individual's level of autonomic arousal, situational anxiety, subjective anxiety, and muscle response. Stress items are difficulty to relax, nervous stimulation, upset and boredom, discomfort, overreaction and intolerance. measures the level of symptoms. The total scores of the scale vary between 0 and 42 for each sub-dimension, and as the score increases, depression, anxiety and stress increase. In the scale, depression, anxiety and stress are divided into five categories as normal, mild, moderate, severe and very severe. | Four weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Irritable Bowel Syndrome, patient, stress ball, Depression, Anxiety, Stress, Quality of Life