Irritable Bowel SyndromeNCT05931107
Effect of Stress Ball on Irritable Bowel Syndrome
A study testing Stress ball practice group (Stress ball squeezing) in people with Irritable Bowel Syndrome and Quality of Life, run by Bedriye Cansu DEMİRKIRAN at 1 site in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Irritable Bowel Syndrome, Quality of Life, Depression
- What is being tested?
- Stress ball practice group (Stress ball squeezing)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Jul 2023to 9 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effect of Stress Ball in Patients With Irritable Bowel Syndrome
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
Read the 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.
- Conditions
- Irritable Bowel Syndrome, Quality of Life, Depression, Anxiety, Stress
- Being tested
- Stress ball practice group (Stress ball squeezing)
- Keywords
- Irritable Bowel Syndrome, patient, stress ball, Depression, Anxiety, Stress, Quality of Life
- Medical subject headings
- Irritable Bowel Syndrome, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Four weeks
Secondary outcomes (2)
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.
Measured: 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.
Measured: Four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2023
- Study start19 Jul 2023
- Primary completion12 Sep 2023
- Study completion9 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bedriye Cansu DEMİRKIRAN
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Bedriye Cansu DEMİRKIRAN, Ataturk University
- Investigators
- Ataturk University, Study director, Ataturk University Faculty of Nursing / Erzurum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05931107
- Sponsor's protocol ID
- Cansutez
- Status last verified
- Jul 2024
- First submitted
- 27 Jun 2023
- Last updated
- 31 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Stress Ball in Patients With Irritable Bowel Syndrome
- ClinicalTrials.gov ID
- NCT05931107
- Acronym / sponsor ID
- Cansutez
- Conditions
- Irritable Bowel Syndrome, Quality of Life, Depression, Anxiety, Stress
- Keywords
- Irritable Bowel Syndrome, patient, stress ball, Depression, Anxiety, Stress, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Bedriye Cansu DEMİRKIRANUniversity, hospital or other
- Study start
- 19 Jul 2023 (actual)
- Primary completion
- 12 Sep 2023 (actual)
- Study completion
- 9 Oct 2023 (actual)
- First posted
- 5 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stress ball practice group (Stress ball squeezing) | Experimental | Other: Stress ball practice group (Stress ball squeezing)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. |
| 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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,
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stress ball practice group (Stress ball squeezing)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. | Other | Stress ball practice group (Stress ball squeezing) |
Primary outcome
Irritable Bowel Syndrome Symptom Severity Score,
Time frame: Four weeks
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.
2 secondary outcomes
Irritable Bowel Syndrome Quality of Life Scale
Time frame: Four weeks
Depression-Anxiety-Stress Scale
Time frame: Four weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ataturk University study director
Ataturk University Faculty of Nursing / Erzurum
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stress ball practice group (Stress ball squeezing) in people with Irritable Bowel Syndrome and Quality of Life, run by Bedriye Cansu DEMİRKIRAN at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Irritable Bowel Syndrome Symptom Severity Score, (time frame: Four weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2024.