Clinical trial NCT05931107: Effect of Stress Ball on Irritable Bowel Syndrome
Official title: Evaluation of the Effect of Stress Ball in Patients With Irritable Bowel Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Irritable Bowel Syndrome
Quality of Life
Depression
Anxiety
Stress
Keywords: Irritable Bowel Syndrome
patient
stress ball
Depression
Anxiety
Stress
Quality of Life
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2023-07-05
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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

Detailed description: 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 record will be created and they will be asked to mark the data showing the amount of application each day to be allocated. The IBS symptom score will be evaluated by searching the prices of each week.

There will be no intervention in the control units. Phone numbers of patients in this group will be taken, and IBS symptom severity scores will be evaluated every week.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Irritable Bowel Syndrome Symptom Severity Score,
timeFrame: Four weeks
Secondary outcomes:
measure: Irritable Bowel Syndrome Quality of Life Scale
timeFrame: Four weeks
measure: Depression-Anxiety-Stress Scale
timeFrame: Four weeks
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: Erzurum City Hospital
Study officials:
affiliation: Ataturk University Faculty of Nursing / Erzurum
name: Ataturk University
role: STUDY_DIRECTOR
References: