Trial Outcomes & Findings for Hypnotherapy With Audiofiles for Children and Adolescents With Disorders of Gut-brain Interactions in Sweden -a Feasibility Study (NCT NCT06493097)
NCT ID: NCT06493097
Last Updated: 2026-01-30
Results Overview
Short questionnaire gastrointestinal symptom scale. Minimum value 0, maximum value 100, higher score means better outcome.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
32 participants
Primary outcome timeframe
Week 0 (pre) and 12 (post) of treatment. The post-treatment measurement must be finished within 2 weeks from end of treatment.
Results posted on
2026-01-30
Participant Flow
Children and adolescents with DGBI aged 8-17 years at the start of the treatment were recruited from Sachs Children's Hospital and four outpatient pediatric clinics in Stockholm between October 2023 and June 2024.
Participants received the intervention within 4 weeks from enrollment, all participants received same intervention in this pilot study.
Participant milestones
| Measure |
Treatment With Hypnotherapy Audio Files
Participants get access to a website, where they can find information about the diagnosis DGBI and mechanisms leading to symtoms. On the website they also get access to a tretament protocoll for self-hypnosis with audio files (5 different audio files, age-adjusted). Participants listen to audio files min 5 times/week for 12 weeks. They answer the study questionnaries before and after the treatment.
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|---|---|
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Overall Study
STARTED
|
32
|
|
Overall Study
COMPLETED
|
25
|
|
Overall Study
NOT COMPLETED
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Treatment With Hypnotherapy Audio Files
n=32 Participants
Participants get access to a website, where they can find information about the diagnosis DGBI and mechanisms leading to symtoms. On the website they also get access to a tretament protocoll for self-hypnosis with audio files (5 different audio files, age-adjusted). Participants listen to audio files min 5 times/week for 12 weeks. They answer the study questionnaries before and after the treatment.
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|---|---|
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Age, Categorical
<=18 years
|
32 Participants
n=32 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=32 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=32 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=32 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=32 Participants
|
|
Region of Enrollment
Sweden
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32 Participants
n=32 Participants
|
|
Symtom duration >2 years
|
24 Participants
n=32 Participants
|
|
Diagnosis IBS (irritable bowel syndrome)
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22 Participants
n=32 Participants
|
|
Diagnosis FAP-NOS (functional abdominal pain - not otherwise specified)
|
5 Participants
n=32 Participants
|
|
Diagnosis FD (functional dyspepsia)
|
5 Participants
n=32 Participants
|
PRIMARY outcome
Timeframe: Week 0 (pre) and 12 (post) of treatment. The post-treatment measurement must be finished within 2 weeks from end of treatment.Short questionnaire gastrointestinal symptom scale. Minimum value 0, maximum value 100, higher score means better outcome.
Outcome measures
| Measure |
Treatment With Hypnotherapy Audio Files
n=25 Participants
Participants get access to a website, where they can find information about the diagnosis DGBI and mechanisms leading to symtoms. On the website they also get access to a tretament protocoll for self-hypnosis with audio files (5 different audio files, age-adjusted). Participants listen to audio files min 5 times/week for 12 weeks. They answer the study questionnaries before, after and every 3 weeks during the treatment.
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|---|---|
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Peds-QL-gastro
Baseline
|
49.91 units on a scale
Standard Deviation 13.43
|
|
Peds-QL-gastro
Post-intervention
|
60.15 units on a scale
Standard Deviation 14.01
|
SECONDARY outcome
Timeframe: Week 0 (pre) and 12 (post) of treatment. The post-treatment measurement must be finished within 2 weeks from end of treatment.FACES pain scale. Minimum value 0, maximum value 10, higher score means worse outcome.
Outcome measures
| Measure |
Treatment With Hypnotherapy Audio Files
n=25 Participants
Participants get access to a website, where they can find information about the diagnosis DGBI and mechanisms leading to symtoms. On the website they also get access to a tretament protocoll for self-hypnosis with audio files (5 different audio files, age-adjusted). Participants listen to audio files min 5 times/week for 12 weeks. They answer the study questionnaries before, after and every 3 weeks during the treatment.
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|---|---|
|
Pain Frequency and Intensity
Baseline
|
5.69 units on a scale
Standard Deviation 2.28
|
|
Pain Frequency and Intensity
Post-intervention
|
4.54 units on a scale
Standard Deviation 2.3
|
SECONDARY outcome
Timeframe: Week 0 (pre) and 12 (post) of treatment. The post-treatment measurement must be finished within 2 weeks from end of treatment.PAS pediatric stress questionnare. Minimum value 0, maximum value 44, higher score means worse outcome.
Outcome measures
| Measure |
Treatment With Hypnotherapy Audio Files
n=25 Participants
Participants get access to a website, where they can find information about the diagnosis DGBI and mechanisms leading to symtoms. On the website they also get access to a tretament protocoll for self-hypnosis with audio files (5 different audio files, age-adjusted). Participants listen to audio files min 5 times/week for 12 weeks. They answer the study questionnaries before, after and every 3 weeks during the treatment.
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|---|---|
|
Stress
Baseline
|
15.78 units on a scale
Standard Deviation 10.33
|
|
Stress
Post-intervention
|
19.4 units on a scale
Standard Deviation 11.15
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SECONDARY outcome
Timeframe: Week 0 (pre) and 12 (post) of treatment. The post-treatment measurement must be finished within 2 weeks from end of treatment.BRQ-C questionnare. Minimum value 11, maximum value 77, higher score means worse outcome.
Outcome measures
| Measure |
Treatment With Hypnotherapy Audio Files
n=25 Participants
Participants get access to a website, where they can find information about the diagnosis DGBI and mechanisms leading to symtoms. On the website they also get access to a tretament protocoll for self-hypnosis with audio files (5 different audio files, age-adjusted). Participants listen to audio files min 5 times/week for 12 weeks. They answer the study questionnaries before, after and every 3 weeks during the treatment.
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|---|---|
|
Gastrointestinal Symtom -Related Anxiety
Baseline
|
35.59 units on a scale
Standard Deviation 13.38
|
|
Gastrointestinal Symtom -Related Anxiety
Post-intervention
|
35.65 units on a scale
Standard Deviation 13.64
|
SECONDARY outcome
Timeframe: Week 0 (pre) and 12 (post) of treatment. The post-treatment measurement must be finished within 2 weeks from end of treatment.Visceral sensitivity index short scale. Minimum value 0, maximum value 35, higher score means worse outcome.
Outcome measures
| Measure |
Treatment With Hypnotherapy Audio Files
n=25 Participants
Participants get access to a website, where they can find information about the diagnosis DGBI and mechanisms leading to symtoms. On the website they also get access to a tretament protocoll for self-hypnosis with audio files (5 different audio files, age-adjusted). Participants listen to audio files min 5 times/week for 12 weeks. They answer the study questionnaries before, after and every 3 weeks during the treatment.
|
|---|---|
|
GI Symptom Specific Anxiety
Baseline
|
17.38 units on a scale
Standard Deviation 9.14
|
|
GI Symptom Specific Anxiety
Post-intervention
|
6.56 units on a scale
Standard Deviation 8.22
|
SECONDARY outcome
Timeframe: Week 0 (pre) and 12 (post) of treatment. The post-treatment measurement must be finished within 2 weeks from end of treatment.Peds-QL- QOL. Minimum value 0, maximum value 100, higher score means better outcome.
Outcome measures
| Measure |
Treatment With Hypnotherapy Audio Files
n=25 Participants
Participants get access to a website, where they can find information about the diagnosis DGBI and mechanisms leading to symtoms. On the website they also get access to a tretament protocoll for self-hypnosis with audio files (5 different audio files, age-adjusted). Participants listen to audio files min 5 times/week for 12 weeks. They answer the study questionnaries before, after and every 3 weeks during the treatment.
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|---|---|
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Quality of Life
Baseline
|
70.48 units on a scale
Standard Deviation 11.68
|
|
Quality of Life
Post-intervention
|
73.54 units on a scale
Standard Deviation 15.59
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SECONDARY outcome
Timeframe: Week 12 (post) treatment. The post-treatment measurement must be finished within 2 weeks from end of treatment.SAQ. Minimum value 0, maximum value 7, higher score means better outcome.
Outcome measures
| Measure |
Treatment With Hypnotherapy Audio Files
n=25 Participants
Participants get access to a website, where they can find information about the diagnosis DGBI and mechanisms leading to symtoms. On the website they also get access to a tretament protocoll for self-hypnosis with audio files (5 different audio files, age-adjusted). Participants listen to audio files min 5 times/week for 12 weeks. They answer the study questionnaries before, after and every 3 weeks during the treatment.
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|---|---|
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Adequate Relief
|
4.12 units on a scale
Standard Deviation 0.83
|
Adverse Events
Treatment With Hypnotherapy Audio Files
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place