Hypnotherapy for Abdominal Pain in Childhood.

Gut-directed hypnotherapy in children with irritable bowel syndrome: Self exercises at home using recorded scripts on CD versus individual therapy by qualified therapists.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON27382

Enrollment

260

Registered

2011-02-01

Start date

2011-04-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kinderen met chronische buikpijn als gevolg van prikkelbaar darm syndroom (IBS) of functionele buikpijn (FAP). Children with chronic abdominal pain due to irritable bowel syndrome (IBS)or functional abdominal pain (FAP).

Interventions

Patients will be randomly allocated using a computerized random-number generato for concealment to individualized hypnotherapy given by a therapist or home-based therapy with hypnosis exercises on CS'

Eligibility

Inclusion criteria

Inclusion criteria: Children between 8 and 18 years diagnosed with bowel syndrome/functional abdominal pain according to the Rome III criteria.

Exclusion criteria

Exclusion criteria: Children < 8 years are too young for formal hypnotherapy and therefore excluded from the study. Other exclusion criteria are a concomitant organic gastrointestinal disease, treatment by another health care professional for abdominal symptoms, mental retardation, insufficient knowledge of the Dutch lanuage and previous hypnose treatment.

Design outcomes

Primary

Measure	Time frame
The main goal in the treatment of IBS and FAP patients is reduction of abdominal pain and therefore pain is our primary outcome. Pain will be assesssed by means of a diary card on which patienst record daily intensity on a 10 point Likert scale and frequency of abdominal pain episodes during a period of 7 consecutive days. Recording of pain during 7 days is elaborate, but has the benefit that the problem of individual variability in symptoms over time will be reduced. Because the intervention of this trail cannot be blinded, recording of symptoms by children (parents) themselves at home reduces the risk of detection bias in comparison with the situation where pain is recorded during a visit (single time point) by the health care professional.	—

Measure

Time frame

The main goal in the treatment of IBS and FAP patients is reduction of abdominal pain and therefore pain is our primary outcome. Pain will be assesssed by means of a diary card on which patienst record daily intensity on a 10 point Likert scale and frequency of abdominal pain episodes during a period of 7 consecutive days. Recording of pain during 7 days is elaborate, but has the benefit that the problem of individual variability in symptoms over time will be reduced. Because the intervention of this trail cannot be blinded, recording of symptoms by children (parents) themselves at home reduces the risk of detection bias in comparison with the situation where pain is recorded during a visit (single time point) by the health care professional.

—

Secondary

Measure	Time frame
Using the same diary, patient will also record associated symptoms including nausea, vomitting, loss of apetite and flatus. Additional outcomes include: Health related quality of life, child somatization scores, health utility index, depression and anxiety, absence of school, helath care resources and costs, reduction of stress hormons.	—

Contacts

Public ContactMarc A. Benninga

Kinderarts MDL, AMC, H7-248 P.O. Box 22660

m.a.benninga@amc.nl+31 (0)20 5663053 / +31 (0)20 5666297

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)