Condition category
Signs and Symptoms
Date applied
04/08/2005
Date assigned
04/08/2005
Last edited
10/06/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr M.A. Benninga

ORCID ID

Contact details

Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
+31 (0)205663053
m.a.benninga@amc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR35

Study information

Scientific title

Acronym

Study hypothesis

Hypnotherapy is a valuable treatment for children with chronic abdominal pain.

Ethics approval

Ethics approval received from local ethics committee.

Study design

Randomised, active controlled, parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Functional abdominal pain

Intervention

Hypnotherapy versus conventional therapy

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Frequency abdominal pain
2. Duration of abdominal pain. Above information is collected with pain diaries (two weeks before study, 1 week, 4 weeks, 8 weeks and 12 weeks during therapy, and 6 months and 12 months after therapy).

Secondary outcome measures

No secondary outcome measures

Overall trial start date

01/08/2002

Overall trial end date

01/08/2005

Reason abandoned

Eligibility

Participant inclusion criteria

Rome II-criteria functional abdominal pain

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

50

Participant exclusion criteria

1. Retardation
2. Abdominal surgery

Recruitment start date

01/08/2002

Recruitment end date

01/08/2005

Locations

Countries of recruitment

Netherlands

Trial participating centre

Meibergdreef 9
Amsterdam
1105 AZ
Netherlands

Sponsor information

Organisation

Academic Medical Centre (AMC) (The Netherlands)

Sponsor details

Emma Kinderziekenhuis
Postbus 22660
Amsterdam
1105 AZ
Netherlands

Sponsor type

University/education

Website

http://www.amc.uva.nl/

Funders

Funder type

University/education

Funder name

Academic Medical Centre (AMC) (The Netherlands) - Paediatric Department

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes