Irritable Bowel SyndromeNCT07216092
Audio-recorded Gut-Hypnotherapy for Sleep and Pain in Pediatric Abdominal Pain Disorders
A study testing Gut-directed Hypnotherapy in people with Irritable Bowel Syndrome and Disorders of Gut-brain Interaction, run by Children's Hospital at Montefiore at 1 site in United States.
Trial summary
Children with irritable bowel syndrome (IBS) and functional abdominal pain- not otherwise specified (FAP-NOS) have higher rates of poor sleep quality. This can be associated with worse abdominal pain and quality of life, but few treatments target sleep. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Irritable Bowel Syndrome, Disorders of Gut-brain Interaction
- What is being tested?
- Gut-directed Hypnotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2023to 25 Nov 2024
- 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 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- English speaking
- ages 8 to 18 years
- met Rome IV criteria for FAP-NOS or IBS
- abdominal pain severity >3/10 in the past 2 weeks
- minimum of 1 day of pain in the past 2 weeks
- mild SRI and/or SD as determined by the PROMIS 4- question short-form questionnaires
- stable medication regimen or dietary therapy for >2 weeks prior to enrollment
Who cannot join
- disability that could hinder their understanding of the audio material
- previous experience with guided imagery for treatment of abdominal pain
- psychiatric disorder with psychotic elements such as dissociative symptoms
- other chronic gastrointestinal disease including inflammatory bowel disease, celiac disease, or eosinophilic esophagitis
- other chronic inflammatory conditions
- previous gastrointestinal surgery
- a diagnosis of a sleep disorder such as narcolepsy or sleep apnea.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital at Montefiore
Mahwah, New Jersey, 07430
About this study
Official title: The Role of Audio-recorded Gut-hypnotherapy on Sleep Disturbance, Sleep-related Impairment and Abdominal Pain in Pediatric Functional Abdominal Pain Disorders
Children with irritable bowel syndrome (IBS) and functional abdominal pain- not otherwise specified (FAP-NOS) have higher rates of poor sleep quality. This can be associated with worse abdominal pain and quality of life, but few treatments target sleep. Gut-directed hypnotherapy (GDH) has been shown to reduce abdominal pain and has been hypothesized to improve sleep, but this has not been studied. This study investigates the use of a home-based audio program of GDH as a feasibility intervention for children and whether it can also help with sleep quality. Children aged 8-18 with IBS or FAP-NOS were enrolled from three children's hospitals. Participants in one group completed 6 weeks of GDH sessions at home. Sleep, abdominal pain, and daily functioning were tracked through online surveys. Participants in the control group continued their usual medical care first, and then crossed over into the GDH program.
Read the detailed description
Children with pain-predominant disorders of gut-brain interaction (DGBI) including irritable bowel syndrome (IBS) and functional abdominal pain-not otherwise specified (FAP-NOS) frequently experience sleep-related impairment, which is linked to increased pain severity, functional disability, and health care utilization. Gut-directed hypnotherapy (GDH) is an evidence-based treatment for pediatric DGBI that has been hypothesized to improve sleep, although this has not been studied. This pilot randomized controlled trial evaluates the feasibility of implementing a 6-week, audio-guided GDH program at home and explores effect sizes for sleep, abdominal pain, quality of life, and anxiety outcomes. Children ages 8-18 meeting Rome IV criteria for IBS or FAP-NOS and at least mild sleep disturbance or sleep impairment were recruited virtually from three pediatric gastroenterology centers. Participants were randomized to either standard medical therapy (SMT) or GDH; SMT participants crossed over to GDH after 6 weeks. Primary outcomes were feasibility as measured by adherence, interest, and satisfaction and sleep effect size. Secondary exploratory aims included abdominal pain, functional disability, and anxiety.
- Being tested
- Gut-directed Hypnotherapy
- Keywords
- gut-directed hypnotherapy, disorders of gut-brain interaction, irritable bowel syndrome, sleep-related impairment, sleep disturbance
- Medical subject headings
- Irritable Bowel Syndrome, Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gut-directed HypnotherapyOther
Gut-directed hypnotherapy is an evidence-based treatment that combines hypnosis with therapeutic suggestions that target the gut-brain connection. Through relaxation, imagery, and suggestions, patients learn to better control their pain.
| Study group | Role | What they receive |
|---|---|---|
| Gut-directed hypnotherapy | Experimental | 6-week series of audio-recorded sessions of gut-directed hypnotherapy Receives: Other: Gut-directed Hypnotherapy |
| Standard Medical Therapy | No intervention | This group continued their usual medical care for 6 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of adherence and satisfaction to hypnotherapy treatment protocol
Feasibility was measured through treatment adherence and participant satisfaction. Adherence was measured by number of pre-audio surveys completed and self-reported number of audios completed per week. A 5-point likert scale was used to determine enrolled participant satisfaction with hypnotherapy at the end of the intervention.
Measured: This was assessed throughout the 6 week course by completion of daily abdominal pain surveys and at the end of the 6 week hypnotherapy course.
Treatment effect size for Sleep Quality as measured by PROMIS Questionnaire for sleep-related impairment and sleep disturbance
Patient- reported outcomes measurement information system (PROMIS) sleep related impairment and sleep disturbance surveys were used to measure sleep quality. This scale produces T-scores ranging from about 25-75, normalized to a population mean of 50 and a standard devision of 10. For this measure, a higher T-score indicates a greater severity of sleep related impairment or sleep disturbance.
Measured: enrollment to the end of the 3-month follow up period
Secondary outcomes (3)
Abdominal pain
Defined as pain severity and frequency. Assessed using numerical modified abdominal pain index. Frequency and intensity scores were multiplied to yield a combined score with possible range of 0 to 50. Daily abdominal pain was assessed using Faces pain Scale- reviewed, rating pain from 0-10.
Measured: enrollment to the end of the 3-month follow up period
Functional disability
Disability is assessed and defined by the Functional Disability Inventory tool. This is a numerical tool, resulting in a total score that ranges from 0 to 60. A higher total score indicates greater degree of functional disability.
Measured: enrollment to the end of the 3-month follow up period
Anxiety
Patient- reported outcomes measurement information system (PROMIS) emotional distress-- anxiety was used to measure anxiety. This scale produces T-scores ranging from about 25-75, normalized to a population mean of 50 and a standard devision of 10. For this measure, a higher T-score indicates a greater severity of anxiety symptoms.
Measured: enrollment to the end of the 3-month follow up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2025
- Study start1 Mar 2023
- Primary completion25 Nov 2024
- Study completion25 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital at Montefiore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lily Barash, Children's Hospital at Montefiore
- Investigators
- Rachel Borlack, Principal investigator, Montefiore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07216092
- Sponsor's protocol ID
- 2022-14317
- Status last verified
- Oct 2025
- First submitted
- 17 Sep 2025
- Last updated
- 14 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It is a small sample size, this will risk privacy and confidentiality for participants
Publications
van Tilburg MA, Chitkara DK, Palsson OS, Turner M, Blois-Martin N, Ulshen M, Whitehead WE. Audio-recorded guided imagery treatment reduces functional abdominal pain in children: a pilot study. Pediatrics. 2009 Nov;124(5):e890-7. doi: 10.1542/peds.2009-0028. Epub 2009 Oct 12.
PubMed 19822590Groen J, Gordon M, Chogle A, Benninga M, Borlack R, Borrelli O, Darbari A, Dolinsek J, Khlevner J, Di Lorenzo C, Person H, Sanghavi R, Snyder J, Thapar N, Vlieger A, Sinopoulou V, Tabbers M, Saps M. ESPGHAN/NASPGHAN guidelines for treatment of irritable bowel syndrome and functional abdominal pain-not otherwise specified in children aged 4-18 years. J Pediatr Gastroenterol Nutr. 2025 Aug;81(2):442-471. doi: 10.1002/jpn3.70070. Epub 2025 May 30.
PubMed 40444524Palsson OS, van Tilburg M. Hypnosis and Guided Imagery Treatment for Gastrointestinal Disorders: Experience With Scripted Protocols Developed at the University of North Carolina. Am J Clin Hypn. 2015 Jul;58(1):5-21. doi: 10.1080/00029157.2015.1012705.
PubMed 26046714Mamoune S, Mener E, Chapron A, Poimboeuf J. Hypnotherapy and insomnia: A narrative review of the literature. Complement Ther Med. 2022 May;65:102805. doi: 10.1016/j.ctim.2022.102805. Epub 2022 Jan 21.
PubMed 35074550Rutten JMTM, Vlieger AM, Frankenhuis C, George EK, Groeneweg M, Norbruis OF, Tjon A Ten W, van Wering HM, Dijkgraaf MGW, Merkus MP, Benninga MA. Home-Based Hypnotherapy Self-exercises vs Individual Hypnotherapy With a Therapist for Treatment of Pediatric Irritable Bowel Syndrome, Functional Abdominal Pain, or Functional Abdominal Pain Syndrome: A Randomized Clinical Trial. JAMA Pediatr. 2017 May 1;171(5):470-477. doi: 10.1001/jamapediatrics.2017.0091.
PubMed 28346581Vasant DH, Hasan SS, Cruickshanks P, Whorwell PJ. Gut-focused hypnotherapy for children and adolescents with irritable bowel syndrome. Frontline Gastroenterol. 2020 Nov 23;12(7):570-577. doi: 10.1136/flgastro-2020-101679. eCollection 2021.
PubMed 34917314Gulewitsch MD, Muller J, Hautzinger M, Schlarb AA. Brief hypnotherapeutic-behavioral intervention for functional abdominal pain and irritable bowel syndrome in childhood: a randomized controlled trial. Eur J Pediatr. 2013 Aug;172(8):1043-51. doi: 10.1007/s00431-013-1990-y. Epub 2013 Apr 9.
PubMed 23568514Santucci NR, Velasco-Benitez CA, Velasco-Suarez DA, King C, Byars K, Dye T, Li J, Saps M. Youth With Functional Abdominal Pain Disorders Have More Sleep Disturbances. A School-Based Study. Neurogastroenterol Motil. 2025 Apr;37(4):e14992. doi: 10.1111/nmo.14992. Epub 2024 Dec 31.
PubMed 39737536Haim A, Pillar G, Pecht A, Lerner A, Tov N, Jaffe M, Hardoff D. Sleep patterns in children and adolescents with functional recurrent abdominal pain: objective versus subjective assessment. Acta Paediatr. 2004 May;93(5):677-80.
PubMed 15174794Huntley ED, Campo JV, Dahl RE, Lewin DS. Sleep characteristics of youth with functional abdominal pain and a healthy comparison group. J Pediatr Psychol. 2007 Sep;32(8):938-49. doi: 10.1093/jpepsy/jsm032. Epub 2007 Jul 12.
PubMed 17627965Patel A, Hasak S, Cassell B, Ciorba MA, Vivio EE, Kumar M, Gyawali CP, Sayuk GS. Effects of disturbed sleep on gastrointestinal and somatic pain symptoms in irritable bowel syndrome. Aliment Pharmacol Ther. 2016 Aug;44(3):246-58. doi: 10.1111/apt.13677. Epub 2016 May 30.
PubMed 27240555Murphy LK, Palermo TM, Tham SW, Stone AL, Han GT, Bruehl S, Garber J, Walker LS. Comorbid Sleep Disturbance in Adolescents with Functional Abdominal Pain. Behav Sleep Med. 2021 Jul-Aug;19(4):471-480. doi: 10.1080/15402002.2020.1781634. Epub 2020 Jun 23.
PubMed 32573267Schurman JV, Friesen CA, Dai H, Danda CE, Hyman PE, Cocjin JT. Sleep problems and functional disability in children with functional gastrointestinal disorders: an examination of the potential mediating effects of physical and emotional symptoms. BMC Gastroenterol. 2012 Oct 15;12:142. doi: 10.1186/1471-230X-12-142.
PubMed 23067390Thapar N, Benninga MA, Crowell MD, Di Lorenzo C, Mack I, Nurko S, Saps M, Shulman RJ, Szajewska H, van Tilburg MAL, Enck P. Paediatric functional abdominal pain disorders. Nat Rev Dis Primers. 2020 Nov 5;6(1):89. doi: 10.1038/s41572-020-00222-5.
PubMed 33154368
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Audio-recorded Gut-hypnotherapy on Sleep Disturbance, Sleep-related Impairment and Abdominal Pain in Pediatric Functional Abdominal Pain Disorders
- ClinicalTrials.gov ID
- NCT07216092
- Acronym / sponsor ID
- 2022-14317
- Keywords
- gut-directed hypnotherapy, disorders of gut-brain interaction, irritable bowel syndrome, sleep-related impairment, sleep disturbance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Children's Hospital at MontefioreUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 25 Nov 2024 (actual)
- Study completion
- 25 Nov 2024 (actual)
- First posted
- 14 Oct 2025 (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.
Children with irritable bowel syndrome (IBS) and functional abdominal pain- not otherwise specified (FAP-NOS) have higher rates of poor sleep quality. This can be associated with worse abdominal pain and quality of life, but few treatments target sleep. Gut-directed hypnotherapy (GDH) has been shown to reduce abdominal pain and has been hypothesized to improve sleep, but this has not been studied. This study investigates the use of a home-based audio program of GDH as a feasibility intervention for children and whether it can also help with sleep quality. Children aged 8-18 with IBS or FAP-NOS were enrolled from three children's hospitals. Participants in one group completed 6 weeks of GDH sessions at home. Sleep, abdominal pain, and daily functioning were tracked through online surveys. Participants in the control group continued their usual medical care first, and then crossed over into the GDH program.
Detailed description
Children with pain-predominant disorders of gut-brain interaction (DGBI) including irritable bowel syndrome (IBS) and functional abdominal pain-not otherwise specified (FAP-NOS) frequently experience sleep-related impairment, which is linked to increased pain severity, functional disability, and health care utilization. Gut-directed hypnotherapy (GDH) is an evidence-based treatment for pediatric DGBI that has been hypothesized to improve sleep, although this has not been studied. This pilot randomized controlled trial evaluates the feasibility of implementing a 6-week, audio-guided GDH program at home and explores effect sizes for sleep, abdominal pain, quality of life, and anxiety outcomes. Children ages 8-18 meeting Rome IV criteria for IBS or FAP-NOS and at least mild sleep disturbance or sleep impairment were recruited virtually from three pediatric gastroenterology centers. Participants were randomized to either standard medical therapy (SMT) or GDH; SMT participants crossed over to GDH after 6 weeks. Primary outcomes were feasibility as measured by adherence, interest, and satisfaction and sleep effect size. Secondary exploratory aims included abdominal pain, functional disability, and anxiety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gut-directed hypnotherapy | Experimental | Other: Gut-directed Hypnotherapy6-week series of audio-recorded sessions of gut-directed hypnotherapy |
| Standard Medical Therapy | No intervention | –This group continued their usual medical care for 6 weeks |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- English speaking
- ages 8 to 18 years
- met Rome IV criteria for FAP-NOS or IBS
- abdominal pain severity >3/10 in the past 2 weeks
- minimum of 1 day of pain in the past 2 weeks
Key exclusion criteria (7 listed)
- disability that could hinder their understanding of the audio material
- previous experience with guided imagery for treatment of abdominal pain
- psychiatric disorder with psychotic elements such as dissociative symptoms
- other chronic gastrointestinal disease including inflammatory bowel disease, celiac disease, or eosinophilic esophagitis
- other chronic inflammatory conditions
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 |
|---|---|---|
| Gut-directed HypnotherapyGut-directed hypnotherapy is an evidence-based treatment that combines hypnosis with therapeutic suggestions that target the gut-brain connection. Through relaxation, imagery, and suggestions, patients learn to better control their pain. | Other | Gut-directed hypnotherapy |
Primary outcome
Feasibility of adherence and satisfaction to hypnotherapy treatment protocol
Time frame: This was assessed throughout the 6 week course by completion of daily abdominal pain surveys and at the end of the 6 week hypnotherapy course.
Feasibility was measured through treatment adherence and participant satisfaction. Adherence was measured by number of pre-audio surveys completed and self-reported number of audios completed per week. A 5-point likert scale was used to determine enrolled participant satisfaction with hypnotherapy at the end of the intervention.
Treatment effect size for Sleep Quality as measured by PROMIS Questionnaire for sleep-related impairment and sleep disturbance
Time frame: enrollment to the end of the 3-month follow up period
Patient- reported outcomes measurement information system (PROMIS) sleep related impairment and sleep disturbance surveys were used to measure sleep quality. This scale produces T-scores ranging from about 25-75, normalized to a population mean of 50 and a standard devision of 10. For this measure, a higher T-score indicates a greater severity of sleep related impairment or sleep disturbance.
3 secondary outcomes
Abdominal pain
Time frame: enrollment to the end of the 3-month follow up period
Functional disability
Time frame: enrollment to the end of the 3-month follow up period
Anxiety
Time frame: enrollment to the end of the 3-month follow up period
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 14 Oct 2025.
- Background: PubMed 19822590van Tilburg MA, Chitkara DK, Palsson OS, Turner M, Blois-Martin N, Ulshen M, Whitehead WE. Audio-recorded guided imagery treatment reduces functional abdominal pain in children: a pilot study. Pediatrics. 2009 Nov;124(5):e890-7. doi: 10.1542/peds.2009-0028. Epub 2009 Oct 12.
- Background: PubMed 40444524Groen J, Gordon M, Chogle A, Benninga M, Borlack R, Borrelli O, Darbari A, Dolinsek J, Khlevner J, Di Lorenzo C, Person H, Sanghavi R, Snyder J, Thapar N, Vlieger A, Sinopoulou V, Tabbers M, Saps M. ESPGHAN/NASPGHAN guidelines for treatment of irritable bowel syndrome and functional abdominal pain-not otherwise specified in children aged 4-18 years. J Pediatr Gastroenterol Nutr. 2025 Aug;81(2):442-471. doi: 10.1002/jpn3.70070. Epub 2025 May 30.
- Background: PubMed 26046714Palsson OS, van Tilburg M. Hypnosis and Guided Imagery Treatment for Gastrointestinal Disorders: Experience With Scripted Protocols Developed at the University of North Carolina. Am J Clin Hypn. 2015 Jul;58(1):5-21. doi: 10.1080/00029157.2015.1012705.
- Background: PubMed 35074550Mamoune S, Mener E, Chapron A, Poimboeuf J. Hypnotherapy and insomnia: A narrative review of the literature. Complement Ther Med. 2022 May;65:102805. doi: 10.1016/j.ctim.2022.102805. Epub 2022 Jan 21.
- Background: PubMed 28346581Rutten JMTM, Vlieger AM, Frankenhuis C, George EK, Groeneweg M, Norbruis OF, Tjon A Ten W, van Wering HM, Dijkgraaf MGW, Merkus MP, Benninga MA. Home-Based Hypnotherapy Self-exercises vs Individual Hypnotherapy With a Therapist for Treatment of Pediatric Irritable Bowel Syndrome, Functional Abdominal Pain, or Functional Abdominal Pain Syndrome: A Randomized Clinical Trial. JAMA Pediatr. 2017 May 1;171(5):470-477. doi: 10.1001/jamapediatrics.2017.0091.
- Background: PubMed 34917314Vasant DH, Hasan SS, Cruickshanks P, Whorwell PJ. Gut-focused hypnotherapy for children and adolescents with irritable bowel syndrome. Frontline Gastroenterol. 2020 Nov 23;12(7):570-577. doi: 10.1136/flgastro-2020-101679. eCollection 2021.
- Background: PubMed 23568514Gulewitsch MD, Muller J, Hautzinger M, Schlarb AA. Brief hypnotherapeutic-behavioral intervention for functional abdominal pain and irritable bowel syndrome in childhood: a randomized controlled trial. Eur J Pediatr. 2013 Aug;172(8):1043-51. doi: 10.1007/s00431-013-1990-y. Epub 2013 Apr 9.
- Background: PubMed 39737536Santucci NR, Velasco-Benitez CA, Velasco-Suarez DA, King C, Byars K, Dye T, Li J, Saps M. Youth With Functional Abdominal Pain Disorders Have More Sleep Disturbances. A School-Based Study. Neurogastroenterol Motil. 2025 Apr;37(4):e14992. doi: 10.1111/nmo.14992. Epub 2024 Dec 31.
- Background: PubMed 15174794Haim A, Pillar G, Pecht A, Lerner A, Tov N, Jaffe M, Hardoff D. Sleep patterns in children and adolescents with functional recurrent abdominal pain: objective versus subjective assessment. Acta Paediatr. 2004 May;93(5):677-80.
- Background: PubMed 17627965Huntley ED, Campo JV, Dahl RE, Lewin DS. Sleep characteristics of youth with functional abdominal pain and a healthy comparison group. J Pediatr Psychol. 2007 Sep;32(8):938-49. doi: 10.1093/jpepsy/jsm032. Epub 2007 Jul 12.
- Background: PubMed 27240555Patel A, Hasak S, Cassell B, Ciorba MA, Vivio EE, Kumar M, Gyawali CP, Sayuk GS. Effects of disturbed sleep on gastrointestinal and somatic pain symptoms in irritable bowel syndrome. Aliment Pharmacol Ther. 2016 Aug;44(3):246-58. doi: 10.1111/apt.13677. Epub 2016 May 30.
- Background: PubMed 32573267Murphy LK, Palermo TM, Tham SW, Stone AL, Han GT, Bruehl S, Garber J, Walker LS. Comorbid Sleep Disturbance in Adolescents with Functional Abdominal Pain. Behav Sleep Med. 2021 Jul-Aug;19(4):471-480. doi: 10.1080/15402002.2020.1781634. Epub 2020 Jun 23.
- Individual participant dataSharing planned: No. It is a small sample size, this will risk privacy and confidentiality for participants
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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.
Rachel Borlack principal investigator
Montefiore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gut-directed Hypnotherapy in people with Irritable Bowel Syndrome and Disorders of Gut-brain Interaction, run by Children's Hospital at Montefiore 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 7 inclusion and 7 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 14 Oct 2025. 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?
Feasibility of adherence and satisfaction to hypnotherapy treatment protocol (time frame: This was assessed throughout the 6 week course by completion of daily abdominal pain surveys and at the end of the 6 week hypnotherapy course.). The study lists 2 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 NCT07216092, which also lists 14 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 14 Oct 2025.