Pediatric Crohns DiseaseHypnoCrohnsNCT03809195
Clinical Hypnosis in Pediatric Crohn's Disease
A study testing Clinical Hypnosis in people with Pediatric Crohns Disease, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
Inflammatory bowel disease (IBD), which includes Crohn's disease (CD) and ulcerative colitis (UC), is a chronic, immune-mediated disease increasingly prevalent in youth. Patients with IBD experience pain, fatigue, altered bowel habits, psychological distress, and reduced quality of life. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Pediatric Crohns Disease
- What is being tested?
- Clinical Hypnosis
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Feb 2019to 1 May 2020
- 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 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients diagnosed with Crohn's disease at least 3 months prior to enrollment
- Inactive, mild, or moderate disease activity by Improve Care Now Physician's Global Assessment (ICN PGA) at most recent GI clinic visit
- Ages 12-18 years at time of enrollment
- English-speaking and with the normal cognitive development required to understand the verbal instructions/suggestions provided in the hypnosis session/audio recordings and to understand and complete the written surveys
- Has daily access to an electronic device (ex. smartphone, computer) that can receive text messages or e-mail, on which online surveys can be completed, and on which the participant can access and listen to audio recordings.
Who cannot join
- Patients diagnosed with Crohn's disease less than 3 months prior to enrollment
- Severe disease activity per ICN PGA at most recent GI clinic visit
- Age < 12 years or > 18 years
- Non-English speaking or having a cognitive disability that precludes understanding the verbal instructions/suggestions provided in the hypnosis session/audio recordings and the completion of written surveys
- Lacks daily access to an electronic device (ex. smartphone, computer) that can receive text messages or e-mail, on which online surveys can be completed, and on which the participant can access and listen to audio recordings.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
Inflammatory bowel disease (IBD), which includes Crohn's disease (CD) and ulcerative colitis (UC), is a chronic, immune-mediated disease increasingly prevalent in youth. Patients with IBD experience pain, fatigue, altered bowel habits, psychological distress, and reduced quality of life. Regardless of disease activity, persistent pain and psychiatric comorbidities both have a negative impact on quality of life. Alongside standard pharmacologic and nutritional therapies, clinical hypnosis is a complementary therapy that may improve physical and psychosocial outcomes in these patients. Clinical hypnosis consists of guiding the patient into a relaxed and focused state and providing therapeutic suggestions to induce desired physiologic and psychologic change. Children and adolescents are excellent candidates for hypnosis by virtue of their vivid imaginations. Hypnosis is effective in management of functional abdominal pain, irritable bowel syndrome, anxiety, chronic pain, and distress related to medical procedures. To date, there are no clinical trials that evaluate the effects of hypnosis in pediatric patients with IBD, but there is strong conceptual support for its role in improving pain and psychological distress in these patients. In addition to genetic, environmental, and microbial influences, a growing body of evidence supports the role of a dysregulated brain-gut axis and chronic stress in IBD. Animal and human studies demonstrate the effect of stress on the immune system and gastrointestinal tract. Studies show that the benefits of hypnosis may extend to its role in increasing vagal tone and regulating the immune system via the brain-gut axis. Adults with UC receiving a hypnosis intervention demonstrated improved remission and decreased inflammatory markers. Case series suggest that children with inflammatory bowel disease benefit from hypnosis, and it can be safely and easily delivered via audio recordings. Patients with IBD are interested in integrative therapies to reduce symptoms and improve quality of life, and a biopsychosocial approach is essential in their care. The addition of hypnosis may improve outcomes through influence on stress, inflammation, coping, symptom perception, and quality of life.
The investigators hypothesize that pediatric patients with CD participating in a clinical hypnosis intervention as an adjunct to standard of care will report improved quality of life compared to a waitlist control group. The specific aims of the study are as follows: (1) To implement hypnosis as an adjunctive therapy in adolescents with CD. (2) To evaluate the impact of hypnosis in CD on measures of quality of life. (3) To evaluate the impact of hypnosis in CD on pain, depression, anxiety, sleep, and coping.
- Conditions
- Pediatric Crohns Disease
- Being tested
- Clinical Hypnosis
- Keywords
- hypnosis, inflammatory bowel disease, mind-body, brain-gut, hypnotherapy, quality of life, psychosocial
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical HypnosisBehavioural
See information in arm/group description. Four different audio recordings are provided electronically, each approximately 20 minutes in length. Participants are encouraged to listen to one daily.
| Study group | Role | What they receive |
|---|---|---|
| Hypnosis Intervention | Experimental | The intervention is clinical hypnosis--a single in-person session followed by instructions to listen to audio recordings at home. The sessions consist of the provider's voice guiding the participant into a relaxed and focused state and providing therapeutic suggestions--for example, to replace discomfort with a more pleasant sensation, to ease anxiety, and to increase energy. Receives: Behavioral: Clinical Hypnosis |
| Waitlist Control | No intervention | This group will serve as a control comparison and be offered the intervention after control data collection is complete. |
What is being measured
The primary outcome is the main question the study is designed to answer.
IMPACT-III
Pediatric inflammatory bowel disease-specific health-related quality of life measure. "IMPACT" is not an abbreviation, but rather the name of the scale. Minimum score 0 to maximum score 100, with higher signifying better quality of life. Subjects get a total score (0 to 100) and a score for each of six subscales (0 to 100): Bowel Symptoms (7 items), Treatment/Interventions (3 items), Social Functioning (12 items), Emotional Functioning (7 items), Body Image (3 items), Systemic Symptoms (3 items). Each of the 35 total items has five multiple choice options and is given a score of 0, 25, 50, 75, or 100 points. The subscale scores are an average of the scores for each item that corresponds to that subscale. The total score is an average of all item scores.
Measured: Change from baseline to 8 weeks.
Modified Cantril Ladder
Single item quality of life measure. From 0 to 10, with 10 representing the best quality of life.
Measured: Change from baseline to 8 weeks.
PedsQL 4.0 Generic Core Scale, Parent Proxy
"PedsQL" refers to Pediatric Quality of Life. This is a pediatric 23-item measure of health-related quality of life. Questions fall under one of five domains: Physical Functioning (8 items), Emotional Functioning (5), Social Functioning (5 items), School Functioning (5 items). Yields a total score and two summary scores-Physical Health (comprised of physical functioning domain) and Psychosocial Health (comprised of each item in the 5-item emotional, social, and school functioning domains). Each item is rated on a 5-point Likert scale. Total score and the two summary scores are linearly transformed into a 0 to 100 point scale, with higher scores representing better quality of life.
Measured: Change from baseline to 8 weeks.
Secondary outcomes (8)
PROMIS Pediatric Anxiety, short form
PROMIS stands for Patient-Reported Outcomes Measurement Information System. This measure is 8 items each scored from 1 to 5 points, with the lowest possible raw score being 8 and the highest possible raw score being 40. Higher scores indicate greater anxiety, i.e. worse. The raw score is translated into a T-score. The T-score rescales the raw score into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. Therefore, a person with a T-score of 40 is one SD below the mean.
Measured: Change from baseline to 8 weeks.
PROMIS Pediatric Depressive Symptoms, short form
PROMIS stands for Patient-Reported Outcomes Measurement Information System. This measure is 8 items each scored from 1 to 5 points, with the lowest possible raw score being 8 and the highest possible raw score being 40. Higher scores indicate greater depressive symptoms, i.e. worse. The raw score is translated into a T-score. The T-score rescales the raw score into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. Therefore, a person with a T-score of 40 is one SD below the mean.
Measured: Change from baseline to 8 weeks.
PROMIS Pediatric Sleep Disturbance, short form
PROMIS stands for Patient-Reported Outcomes Measurement Information System. This measure is 8 items each scored from 1 to 5 points, with the lowest possible raw score being 8 and the highest possible raw score being 40. Higher scores indicate greater sleep disturbance, i.e. worse sleep. The raw score is translated into a T-score. The T-score rescales the raw score into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. Therefore, a person with a T-score of 40 is one SD below the mean.
Measured: Change from baseline to 8 weeks.
Pain Beliefs Questionnaire, short form
This is an 18-item measure designed assess youth's beliefs about their abdominal pain. It is comprised of three subscales each with 6 items-Pain Threat, Problem-Focused Coping Efficacy (PFCE), and Emotion-Focused Coping Efficacy (EFCE). The respondent rates each item on how true the statement is for them on a 5-point scale ranging from 0 ("not at all true") to 4 ("very true"). Subscale scores are computed by averaging the items pertaining to each subscale. For Pain Threat, higher score indicates stronger beliefs that one's pain represents a personal threat. For the PFCE and EFCE subscales, higher scores indicate a stronger belief in one's ability to cope with pain.
Measured: Change from baseline to 8 weeks.
Abdominal Pain Intensity
Two items combined for a total score, range from 0 to 20, with higher scores representing greater pain intensity. Each item rated on a scale from 0 (no pain) to 10 (most possible pain). The first item assesses the respondent's worst pain in the past week, and the second item assesses the usual intensity of the pain experienced during the past week. Adapted from the Abdominal Pain Index, with permission.
Measured: Change from baseline to 8 weeks.
Healthcare utilization
By parent report, total number of contacts health care provider for their child in the past 8 weeks, other than previously scheduled check-ups, including emergency department visits, urgent care visits, and phone calls or messages to the doctor's office
Measured: Change from baseline to 8 weeks.
School absences
By parent report, number of days of school the child has missed in the past 8 weeks (choices: 0, 1-3, 4-6, 7-10, more than 10 days). If on school break, parent asked to estimate as if school was in session--for example, how many days the child had to miss usual activities.
Measured: Change from baseline to 8 weeks.
Abdominal Pain Frequency
How many days did the respondent experience pain in the past week, with options being never, 1-2 days, 3-4 days, 5-6 days, or daily, with greater frequency of pain being worse. Adapted from the Abdominal Pain Index, with permission.
Measured: Change from baseline to 8 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2019
- Study start14 Feb 2019
- Primary completion30 Sep 2019
- Study completion1 May 2020
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 Pediatric Crohns DiseaseStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- intervention group versus control group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amanda Lee, Vanderbilt University Medical Center
- Investigators
- Amanda D Lee, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03809195
- Sponsor's protocol ID
- 181436
- Acronym
- HypnoCrohns
- Status last verified
- May 2020
- First submitted
- 3 Jan 2019
- Last updated
- 28 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Stone AL, Walker LS, Laird KT, Shirkey KC, Smith CA. Pediatric Pain Beliefs Questionnaire: Psychometric Properties of the Short Form. J Pain. 2016 Sep;17(9):1036-44. doi: 10.1016/j.jpain.2016.06.006. Epub 2016 Jun 27.
PubMed 27363626Forrest CB, Meltzer LJ, Marcus CL, de la Motte A, Kratchman A, Buysse DJ, Pilkonis PA, Becker BD, Bevans KB. Development and validation of the PROMIS Pediatric Sleep Disturbance and Sleep-Related Impairment item banks. Sleep. 2018 Jun 1;41(6). doi: 10.1093/sleep/zsy054.
PubMed 29546286Zhang YZ, Li YY. Inflammatory bowel disease: pathogenesis. World J Gastroenterol. 2014 Jan 7;20(1):91-9. doi: 10.3748/wjg.v20.i1.91.
PubMed 24415861Mackner LM, Greenley RN, Szigethy E, Herzer M, Deer K, Hommel KA. Psychosocial issues in pediatric inflammatory bowel disease: report of the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition. J Pediatr Gastroenterol Nutr. 2013 Apr;56(4):449-58. doi: 10.1097/MPG.0b013e3182841263.
PubMed 23287808Kunz JH, Hommel KA, Greenley RN. Health-related quality of life of youth with inflammatory bowel disease: a comparison with published data using the PedsQL 4.0 generic core scales. Inflamm Bowel Dis. 2010 Jun;16(6):939-46. doi: 10.1002/ibd.21128.
PubMed 19998462Vlieger AM, Menko-Frankenhuis C, Wolfkamp SC, Tromp E, Benninga MA. Hypnotherapy for children with functional abdominal pain or irritable bowel syndrome: a randomized controlled trial. Gastroenterology. 2007 Nov;133(5):1430-6. doi: 10.1053/j.gastro.2007.08.072. Epub 2007 Sep 2.
PubMed 17919634Palsson OS. Hypnosis Treatment of Gastrointestinal Disorders: A Comprehensive Review of the Empirical Evidence. Am J Clin Hypn. 2015 Oct;58(2):134-58. doi: 10.1080/00029157.2015.1039114.
PubMed 26264539Bonaz BL, Bernstein CN. Brain-gut interactions in inflammatory bowel disease. Gastroenterology. 2013 Jan;144(1):36-49. doi: 10.1053/j.gastro.2012.10.003. Epub 2012 Oct 12.
PubMed 23063970Tiles-Sar N, Neuser J, de Sordi D, Baltes A, Preiss JC, Moser G, Timmer A. Psychological interventions for treatment of inflammatory bowel disease. Cochrane Database Syst Rev. 2025 Apr 17;4(4):CD006913. doi: 10.1002/14651858.CD006913.pub3.
PubMed 40243391
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Hypnosis in Pediatric Crohn's Disease
- ClinicalTrials.gov ID
- NCT03809195
- Acronym / sponsor ID
- HypnoCrohns / 181436
- Conditions
- Pediatric Crohns Disease
- Keywords
- hypnosis, inflammatory bowel disease, mind-body, brain-gut, hypnotherapy, quality of life, psychosocial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 14 Feb 2019 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 1 May 2020 (actual)
- First posted
- 18 Jan 2019 (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.
Inflammatory bowel disease (IBD), which includes Crohn's disease (CD) and ulcerative colitis (UC), is a chronic, immune-mediated disease increasingly prevalent in youth. Patients with IBD experience pain, fatigue, altered bowel habits, psychological distress, and reduced quality of life. Regardless of disease activity, persistent pain and psychiatric comorbidities both have a negative impact on quality of life. Alongside standard pharmacologic and nutritional therapies, clinical hypnosis is a complementary therapy that may improve physical and psychosocial outcomes in these patients. Clinical hypnosis consists of guiding the patient into a relaxed and focused state and providing therapeutic suggestions to induce desired physiologic and psychologic change. Children and adolescents are excellent candidates for hypnosis by virtue of their vivid imaginations. Hypnosis is effective in management of functional abdominal pain, irritable bowel syndrome, anxiety, chronic pain, and distress related to medical procedures. To date, there are no clinical trials that evaluate the effects of hypnosis in pediatric patients with IBD, but there is strong conceptual support for its role in improving pain and psychological distress in these patients. In addition to genetic, environmental, and microbial influences, a growing body of evidence supports the role of a dysregulated brain-gut axis and chronic stress in IBD. Animal and human studies demonstrate the effect of stress on the immune system and gastrointestinal tract. Studies show that the benefits of hypnosis may extend to its role in increasing vagal tone and regulating the immune system via the brain-gut axis. Adults with UC receiving a hypnosis intervention demonstrated improved remission and decreased inflammatory markers. Case series suggest that children with inflammatory bowel disease benefit from hypnosis, and it can be safely and easily delivered via audio recordings. Patients with IBD are interested in integrative therapies to reduce symptoms and improve quality of life, and a biopsychosocial approach is essential in their care. The addition of hypnosis may improve outcomes through influence on stress, inflammation, coping, symptom perception, and quality of life.
The investigators hypothesize that pediatric patients with CD participating in a clinical hypnosis intervention as an adjunct to standard of care will report improved quality of life compared to a waitlist control group. The specific aims of the study are as follows: (1) To implement hypnosis as an adjunctive therapy in adolescents with CD. (2) To evaluate the impact of hypnosis in CD on measures of quality of life. (3) To evaluate the impact of hypnosis in CD on pain, depression, anxiety, sleep, and coping.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- intervention group versus control group
| Arm | Type | Receives |
|---|---|---|
| Hypnosis Intervention | Experimental | Behavioral: Clinical HypnosisThe intervention is clinical hypnosis--a single in-person session followed by instructions to listen to audio recordings at home. The sessions consist of the provider's voice guiding the participant into a relaxed and focused state and providing therapeutic suggestions--for example, to replace discomfort with a more pleasant sensation, to ease anxiety, and to increase energy. |
| Waitlist Control | No intervention | –This group will serve as a control comparison and be offered the intervention after control data collection is complete. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Patients diagnosed with Crohn's disease at least 3 months prior to enrollment
- Inactive, mild, or moderate disease activity by Improve Care Now Physician's Global Assessment (ICN PGA) at most recent GI clinic visit
- Ages 12-18 years at time of enrollment
- English-speaking and with the normal cognitive development required to understand the verbal instructions/suggestions provided in the hypnosis session/audio recordings and to understand and complete the written surveys
- Has daily access to an electronic device (ex. smartphone, computer) that can receive text messages or e-mail, on which online surveys can be completed, and on which the participant can access and listen to audio recordings.
Key exclusion criteria (5 listed)
- Patients diagnosed with Crohn's disease less than 3 months prior to enrollment
- Severe disease activity per ICN PGA at most recent GI clinic visit
- Age < 12 years or > 18 years
- Non-English speaking or having a cognitive disability that precludes understanding the verbal instructions/suggestions provided in the hypnosis session/audio recordings and the completion of written surveys
- Lacks daily access to an electronic device (ex. smartphone, computer) that can receive text messages or e-mail, on which online surveys can be completed, and on which the participant can access and listen to audio recordings.
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 |
|---|---|---|
| Clinical HypnosisSee information in arm/group description. Four different audio recordings are provided electronically, each approximately 20 minutes in length. Participants are encouraged to listen to one daily. | Behavioural | Hypnosis Intervention |
Primary outcome
IMPACT-III
Time frame: Change from baseline to 8 weeks.
Pediatric inflammatory bowel disease-specific health-related quality of life measure. "IMPACT" is not an abbreviation, but rather the name of the scale. Minimum score 0 to maximum score 100, with higher signifying better quality of life. Subjects get a total score (0 to 100) and a score for each of six subscales (0 to 100): Bowel Symptoms (7 items), Treatment/Interventions (3 items), Social Functioning (12 items), Emotional Functioning (7 items), Body Image (3 items), Systemic Symptoms (3 items). Each of the 35 total items has five multiple choice options and is given a score of 0, 25, 50, 75, or 100 points. The subscale scores are an average of the scores for each item that corresponds to that subscale. The total score is an average of all item scores.
Modified Cantril Ladder
Time frame: Change from baseline to 8 weeks.
Single item quality of life measure. From 0 to 10, with 10 representing the best quality of life.
PedsQL 4.0 Generic Core Scale, Parent Proxy
Time frame: Change from baseline to 8 weeks.
"PedsQL" refers to Pediatric Quality of Life. This is a pediatric 23-item measure of health-related quality of life. Questions fall under one of five domains: Physical Functioning (8 items), Emotional Functioning (5), Social Functioning (5 items), School Functioning (5 items). Yields a total score and two summary scores-Physical Health (comprised of physical functioning domain) and Psychosocial Health (comprised of each item in the 5-item emotional, social, and school functioning domains). Each item is rated on a 5-point Likert scale. Total score and the two summary scores are linearly transformed into a 0 to 100 point scale, with higher scores representing better quality of life.
8 secondary outcomes
PROMIS Pediatric Anxiety, short form
Time frame: Change from baseline to 8 weeks.
PROMIS Pediatric Depressive Symptoms, short form
Time frame: Change from baseline to 8 weeks.
PROMIS Pediatric Sleep Disturbance, short form
Time frame: Change from baseline to 8 weeks.
Pain Beliefs Questionnaire, short form
Time frame: Change from baseline to 8 weeks.
Abdominal Pain Intensity
Time frame: Change from baseline to 8 weeks.
Healthcare utilization
Time frame: Change from baseline to 8 weeks.
School absences
Time frame: Change from baseline to 8 weeks.
Abdominal Pain Frequency
Time frame: Change from baseline to 8 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 28 May 2020.
- Background: PubMed 27363626Stone AL, Walker LS, Laird KT, Shirkey KC, Smith CA. Pediatric Pain Beliefs Questionnaire: Psychometric Properties of the Short Form. J Pain. 2016 Sep;17(9):1036-44. doi: 10.1016/j.jpain.2016.06.006. Epub 2016 Jun 27.
- Background: PubMed 29546286Forrest CB, Meltzer LJ, Marcus CL, de la Motte A, Kratchman A, Buysse DJ, Pilkonis PA, Becker BD, Bevans KB. Development and validation of the PROMIS Pediatric Sleep Disturbance and Sleep-Related Impairment item banks. Sleep. 2018 Jun 1;41(6). doi: 10.1093/sleep/zsy054.
- Background: PubMed 24415861Zhang YZ, Li YY. Inflammatory bowel disease: pathogenesis. World J Gastroenterol. 2014 Jan 7;20(1):91-9. doi: 10.3748/wjg.v20.i1.91.
- Background: PubMed 23287808Mackner LM, Greenley RN, Szigethy E, Herzer M, Deer K, Hommel KA. Psychosocial issues in pediatric inflammatory bowel disease: report of the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition. J Pediatr Gastroenterol Nutr. 2013 Apr;56(4):449-58. doi: 10.1097/MPG.0b013e3182841263.
- Background: PubMed 19998462Kunz JH, Hommel KA, Greenley RN. Health-related quality of life of youth with inflammatory bowel disease: a comparison with published data using the PedsQL 4.0 generic core scales. Inflamm Bowel Dis. 2010 Jun;16(6):939-46. doi: 10.1002/ibd.21128.
- Background: PubMed 17919634Vlieger AM, Menko-Frankenhuis C, Wolfkamp SC, Tromp E, Benninga MA. Hypnotherapy for children with functional abdominal pain or irritable bowel syndrome: a randomized controlled trial. Gastroenterology. 2007 Nov;133(5):1430-6. doi: 10.1053/j.gastro.2007.08.072. Epub 2007 Sep 2.
- Background: PubMed 26264539Palsson OS. Hypnosis Treatment of Gastrointestinal Disorders: A Comprehensive Review of the Empirical Evidence. Am J Clin Hypn. 2015 Oct;58(2):134-58. doi: 10.1080/00029157.2015.1039114.
- Background: PubMed 23063970Bonaz BL, Bernstein CN. Brain-gut interactions in inflammatory bowel disease. Gastroenterology. 2013 Jan;144(1):36-49. doi: 10.1053/j.gastro.2012.10.003. Epub 2012 Oct 12.
- Derived from this study: PubMed 40243391Tiles-Sar N, Neuser J, de Sordi D, Baltes A, Preiss JC, Moser G, Timmer A. Psychological interventions for treatment of inflammatory bowel disease. Cochrane Database Syst Rev. 2025 Apr 17;4(4):CD006913. doi: 10.1002/14651858.CD006913.pub3.
- 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.
Amanda D Lee, MD principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical Hypnosis in people with Pediatric Crohns Disease, run by Vanderbilt University Medical Center 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 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 28 May 2020. 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?
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?
IMPACT-III (time frame: Change from baseline to 8 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 NCT03809195, 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 28 May 2020.