Irritable Bowel SyndromeNCT05719246
Standardized Yoga & Meditation Program for Stress Reduction for Adolescents With Irritable Bowel Syndrome
A study testing Yoga in people with Irritable Bowel Syndrome and Anxiety, run by Cooper Norcross Health at 1 site in United States.
Trial summary
Irritable Bowel Syndrome (IBS) is the most common cause of recurrent abdominal pain in children. IBS is a functional gastrointestinal disorder that is linked to motor and sensory physiology, as well as the central nervous system, that presents as abdominal pain with abnormal defecation patterns. Read more about this study
- Who is it for?
- Ages 12 to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Irritable Bowel Syndrome, Anxiety, Quality of Life
- What is being tested?
- Yoga
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Dec 2020to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 12 to 21 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Patients of Cooper Pediatric Gastroenterology practice in Camden, NJ or Voorhees, NJ
- Patients of Cooper Pediatric Gastroenterology practice in Voorhees, NJ
- Participants 12 to 21 years old with any type of IBS diagnosis
- Subjects must be able to access the internet to be able to watch the yoga videos on Youtube
- Patients must complete 4 out of 6 modules to stay in the study
Who cannot join
- Participants under the age of 12
- Participants over the age of 21
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Cooper University Hospital
Camden, New Jersey, 08103
Alla Kushnir, MD, 856-342-2265, kushnir-alla@cooperhealth.edu
Sydney Topfer, BS
About this study
Irritable Bowel Syndrome (IBS) is the most common cause of recurrent abdominal pain in children. IBS is a functional gastrointestinal disorder that is linked to motor and sensory physiology, as well as the central nervous system, that presents as abdominal pain with abnormal defecation patterns. This discomfort leads to emotional stress, decreased quality of life, and anxiety. The study proposes that yoga and mindfulness will decrease anxiety and increase quality of life for patients with IBS. The aim of this study is to measure the impact of a brief, at-home, 6-week twice per week Standardized Yoga \& Meditation Program for Stress Reduction program on anxiety, IBS symptoms, and quality of life in children ages 12-21 diagnosed with IBS.
Read the detailed description
Background: Irritable Bowel Syndrome (IBS), is the most common cause of general recurrent abdominal pain (RAP) in children. IBS is a functional gastrointestinal disorder that is linked to motor and sensory physiology, as well as the central nervous system, that presents as abdominal pain with abnormal defecation patterns. This discomfort often significantly impacts the patient's life, leading to emotional stress, decreased quality of life due to necessary changes in daily living to accommodate bathroom patterns, as well as anxiety and depression. Since IBS is often accompanied by anxiety, along with other psychological and quality of life issues, it will be evaluated whether practicing yoga and mindfulness will decrease anxiety and increase quality of life for patients with IBS
Objective: To measure the impact of a brief, at-home, 6-week twice per week Standardized Yoga \& Meditation Program for Stress Reduction (SYMPro-SR) program on anxiety, IBS symptoms, and quality of life in children ages 12-21 years old diagnosed with Irritable Bowel Syndrome.
Methods: This is a pilot, IRB approved, prospective study. Children ages 12-21 who suffer from any of the four types of Irritable Bowel Syndromes will be identified. Each subject will be asked to fill out the Screen for Child Anxiety Related Disorders, Children Somatic Symptoms Inventory and Pediatric Quality of Life Inventory questionnaires before and after an online, 6- week yoga course. Anxiety will be measured using the Screen for Child Anxiety Related Disorders and quality of life will be measured using Pediatric Quality of Life Inventory and Children Somatic Symptoms Inventory tests. Results of the questionnaires total scores and sub-scales will be analyzed as continuous variables using paired t-tests or the Wilcoxon signed rank tests for the pre-post results and ANCOVA for repeated measures incorporating age, sex, baseline scores, etc. as covariates. Comparisons within the group will be done using Student paired t-test for continuous data. The difference will be considered significant at p<0.05.
- Conditions
- Irritable Bowel Syndrome, Anxiety, Quality of Life
- Being tested
- Yoga
- Medical subject headings
- Irritable Bowel Syndrome, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YogaBehavioural
The yoga video set that the participants will follow is a brief, at-home, 6-week twice per week Standardized Yoga \& Meditation Program for Stress Reduction (SYMPro-SR) program. The videos feature Sydney Topfer guiding the participants through different yoga poses.
| Study group | Role | What they receive |
|---|---|---|
| IBS Patients Doing Yoga | Experimental | All patients will fall under the arm of "IBS Patients Doing Yoga" and will follow the yoga videos that are assigned to them during the study. The participants are their own controls and their symptom changes will be recorded pre- and post-video watching and participation. Receives: Behavioral: Yoga |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pediatric Quality of Life
Pediatric Quality of Life Inventory questionnaire will be used
Measured: Change from Pre intervention to 6 weeks after intervention (at completion of intervention which lasts 6 weeks)
Children Somatic Symptoms Inventory
Children Somatic Symptoms Inventory questionnaire will be used
Measured: Change from Pre intervention to 6 weeks after intervention (at completion of intervention which lasts 6 weeks)
Anxiety
Screen for Child Anxiety Related Disorders questionnaire will be used
Measured: Change from Pre intervention to 6 weeks after intervention (at completion of intervention which lasts 6 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start30 Dec 2020
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cooper Norcross Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alla Kushnir, MD, Principal investigator, Cooper Norcross Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05719246
- Sponsor's protocol ID
- 19-126
- Status last verified
- Oct 2024
- First submitted
- 7 Mar 2022
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chumpitazi BP, Self MM, Czyzewski DI, Cejka S, Swank PR, Shulman RJ. Bristol Stool Form Scale reliability and agreement decreases when determining Rome III stool form designations. Neurogastroenterol Motil. 2016 Mar;28(3):443-8. doi: 10.1111/nmo.12738. Epub 2015 Dec 21.
PubMed 26690980Lacy BE, Patel NK. Rome Criteria and a Diagnostic Approach to Irritable Bowel Syndrome. J Clin Med. 2017 Oct 26;6(11):99. doi: 10.3390/jcm6110099.
PubMed 29072609Locke GR 3rd, Pemberton JH, Phillips SF. AGA technical review on constipation. American Gastroenterological Association. Gastroenterology. 2000 Dec;119(6):1766-78. doi: 10.1053/gast.2000.20392.
PubMed 11113099Khalsa SB, Hickey-Schultz L, Cohen D, Steiner N, Cope S. Evaluation of the mental health benefits of yoga in a secondary school: a preliminary randomized controlled trial. J Behav Health Serv Res. 2012 Jan;39(1):80-90. doi: 10.1007/s11414-011-9249-8.
PubMed 21647811Huguet A, Izaguirre Eguren J, Miguel-Ruiz D, Vall Valles X, Alda JA. Deficient Emotional Self-Regulation in Children with Attention Deficit Hyperactivity Disorder: Mindfulness as a Useful Treatment Modality. J Dev Behav Pediatr. 2019 Jul/Aug;40(6):425-431. doi: 10.1097/DBP.0000000000000682.
PubMed 31135603Evans S, Seidman LC, Lung K, Sternlieb B, Zeltzer LK. Yoga for Teens With Irritable Bowel Syndrome: Results From a Mixed-Methods Pilot Study. Holist Nurs Pract. 2018 Sep/Oct;32(5):253-260. doi: 10.1097/HNP.0000000000000288.
PubMed 30113959Devanarayana NM, Rajindrajith S. Irritable bowel syndrome in children: Current knowledge, challenges and opportunities. World J Gastroenterol. 2018 Jun 7;24(21):2211-2235. doi: 10.3748/wjg.v24.i21.2211.
PubMed 29881232Reigada LC, Hoogendoorn CJ, Walsh LC, Lai J, Szigethy E, Cohen BH, Bao R, Isola K, Benkov KJ. Anxiety symptoms and disease severity in children and adolescents with Crohn disease. J Pediatr Gastroenterol Nutr. 2015 Jan;60(1):30-5. doi: 10.1097/MPG.0000000000000552.
PubMed 25187105Drossman DA, Camilleri M, Mayer EA, Whitehead WE. AGA technical review on irritable bowel syndrome. Gastroenterology. 2002 Dec;123(6):2108-31. doi: 10.1053/gast.2002.37095. No abstract available.
PubMed 12454866
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Standardized Yoga & Meditation Program for Stress Reduction for Adolescents With Irritable Bowel Syndrome
- ClinicalTrials.gov ID
- NCT05719246
- Acronym / sponsor ID
- 19-126
- Conditions
- Irritable Bowel Syndrome, Anxiety, Quality of Life
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Cooper Norcross HealthUniversity, hospital or other
- Study start
- 30 Dec 2020 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 8 Feb 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.
Irritable Bowel Syndrome (IBS) is the most common cause of recurrent abdominal pain in children. IBS is a functional gastrointestinal disorder that is linked to motor and sensory physiology, as well as the central nervous system, that presents as abdominal pain with abnormal defecation patterns. This discomfort leads to emotional stress, decreased quality of life, and anxiety. The study proposes that yoga and mindfulness will decrease anxiety and increase quality of life for patients with IBS. The aim of this study is to measure the impact of a brief, at-home, 6-week twice per week Standardized Yoga \& Meditation Program for Stress Reduction program on anxiety, IBS symptoms, and quality of life in children ages 12-21 diagnosed with IBS.
Detailed description
Background: Irritable Bowel Syndrome (IBS), is the most common cause of general recurrent abdominal pain (RAP) in children. IBS is a functional gastrointestinal disorder that is linked to motor and sensory physiology, as well as the central nervous system, that presents as abdominal pain with abnormal defecation patterns. This discomfort often significantly impacts the patient's life, leading to emotional stress, decreased quality of life due to necessary changes in daily living to accommodate bathroom patterns, as well as anxiety and depression. Since IBS is often accompanied by anxiety, along with other psychological and quality of life issues, it will be evaluated whether practicing yoga and mindfulness will decrease anxiety and increase quality of life for patients with IBS
Objective: To measure the impact of a brief, at-home, 6-week twice per week Standardized Yoga \& Meditation Program for Stress Reduction (SYMPro-SR) program on anxiety, IBS symptoms, and quality of life in children ages 12-21 years old diagnosed with Irritable Bowel Syndrome.
Methods: This is a pilot, IRB approved, prospective study. Children ages 12-21 who suffer from any of the four types of Irritable Bowel Syndromes will be identified. Each subject will be asked to fill out the Screen for Child Anxiety Related Disorders, Children Somatic Symptoms Inventory and Pediatric Quality of Life Inventory questionnaires before and after an online, 6- week yoga course. Anxiety will be measured using the Screen for Child Anxiety Related Disorders and quality of life will be measured using Pediatric Quality of Life Inventory and Children Somatic Symptoms Inventory tests. Results of the questionnaires total scores and sub-scales will be analyzed as continuous variables using paired t-tests or the Wilcoxon signed rank tests for the pre-post results and ANCOVA for repeated measures incorporating age, sex, baseline scores, etc. as covariates. Comparisons within the group will be done using Student paired t-test for continuous data. The difference will be considered significant at p<0.05.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IBS Patients Doing Yoga | Experimental | Behavioral: YogaAll patients will fall under the arm of "IBS Patients Doing Yoga" and will follow the yoga videos that are assigned to them during the study. The participants are their own controls and their symptom changes will be recorded pre- and post-video watching and participation. |
Who may qualify
- Ages
- 12 to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Patients of Cooper Pediatric Gastroenterology practice in Camden, NJ or Voorhees, NJ
- Patients of Cooper Pediatric Gastroenterology practice in Voorhees, NJ
- Participants 12 to 21 years old with any type of IBS diagnosis
- Subjects must be able to access the internet to be able to watch the yoga videos on Youtube
- Patients must complete 4 out of 6 modules to stay in the study
Key exclusion criteria (2 listed)
- Participants under the age of 12
- Participants over the age of 21
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 |
|---|---|---|
| YogaThe yoga video set that the participants will follow is a brief, at-home, 6-week twice per week Standardized Yoga \& Meditation Program for Stress Reduction (SYMPro-SR) program. The videos feature Sydney Topfer guiding the participants through different yoga poses. | Behavioural | IBS Patients Doing Yoga |
Primary outcome
Pediatric Quality of Life
Time frame: Change from Pre intervention to 6 weeks after intervention (at completion of intervention which lasts 6 weeks)
Pediatric Quality of Life Inventory questionnaire will be used
Children Somatic Symptoms Inventory
Time frame: Change from Pre intervention to 6 weeks after intervention (at completion of intervention which lasts 6 weeks)
Children Somatic Symptoms Inventory questionnaire will be used
Anxiety
Time frame: Change from Pre intervention to 6 weeks after intervention (at completion of intervention which lasts 6 weeks)
Screen for Child Anxiety Related Disorders questionnaire will be used
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Background: PubMed 26690980Chumpitazi BP, Self MM, Czyzewski DI, Cejka S, Swank PR, Shulman RJ. Bristol Stool Form Scale reliability and agreement decreases when determining Rome III stool form designations. Neurogastroenterol Motil. 2016 Mar;28(3):443-8. doi: 10.1111/nmo.12738. Epub 2015 Dec 21.
- Background: PubMed 29072609Lacy BE, Patel NK. Rome Criteria and a Diagnostic Approach to Irritable Bowel Syndrome. J Clin Med. 2017 Oct 26;6(11):99. doi: 10.3390/jcm6110099.
- Background: PubMed 11113099Locke GR 3rd, Pemberton JH, Phillips SF. AGA technical review on constipation. American Gastroenterological Association. Gastroenterology. 2000 Dec;119(6):1766-78. doi: 10.1053/gast.2000.20392.
- Background: PubMed 21647811Khalsa SB, Hickey-Schultz L, Cohen D, Steiner N, Cope S. Evaluation of the mental health benefits of yoga in a secondary school: a preliminary randomized controlled trial. J Behav Health Serv Res. 2012 Jan;39(1):80-90. doi: 10.1007/s11414-011-9249-8.
- Background: PubMed 31135603Huguet A, Izaguirre Eguren J, Miguel-Ruiz D, Vall Valles X, Alda JA. Deficient Emotional Self-Regulation in Children with Attention Deficit Hyperactivity Disorder: Mindfulness as a Useful Treatment Modality. J Dev Behav Pediatr. 2019 Jul/Aug;40(6):425-431. doi: 10.1097/DBP.0000000000000682.
- Background: PubMed 30113959Evans S, Seidman LC, Lung K, Sternlieb B, Zeltzer LK. Yoga for Teens With Irritable Bowel Syndrome: Results From a Mixed-Methods Pilot Study. Holist Nurs Pract. 2018 Sep/Oct;32(5):253-260. doi: 10.1097/HNP.0000000000000288.
- Background: PubMed 29881232Devanarayana NM, Rajindrajith S. Irritable bowel syndrome in children: Current knowledge, challenges and opportunities. World J Gastroenterol. 2018 Jun 7;24(21):2211-2235. doi: 10.3748/wjg.v24.i21.2211.
- Background: PubMed 25187105Reigada LC, Hoogendoorn CJ, Walsh LC, Lai J, Szigethy E, Cohen BH, Bao R, Isola K, Benkov KJ. Anxiety symptoms and disease severity in children and adolescents with Crohn disease. J Pediatr Gastroenterol Nutr. 2015 Jan;60(1):30-5. doi: 10.1097/MPG.0000000000000552.
- Results publication: PubMed 12454866Drossman DA, Camilleri M, Mayer EA, Whitehead WE. AGA technical review on irritable bowel syndrome. Gastroenterology. 2002 Dec;123(6):2108-31. doi: 10.1053/gast.2002.37095. No abstract available.
- 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.
Alla Kushnir, MD principal investigator
Cooper Norcross Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yoga in people with Irritable Bowel Syndrome and Anxiety, run by Cooper Norcross Health at 1 site in United States.
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 5 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 15 Oct 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alla Kushnir, MD (856-342-2265, kushnir-alla@cooperhealth.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pediatric Quality of Life (time frame: Change from Pre intervention to 6 weeks after intervention (at completion of intervention which lasts 6 weeks)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05719246, which also lists 9 linked publications.
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 15 Oct 2024.