Ignite Creation Date:
2024-05-06 @ 2:22 AM
Last Modification Date:
2024-10-26 @ 11:17 AM
Study NCT ID:
NCT02030392
Status:
COMPLETED
Last Update Posted:
2018-01-17
First Post:
2013-10-28
Brief Title:
A Randomized-controlled Study of a Cognitive-behavioral Intervention for Children With Functional Abdominal Pain
Sponsor:
University of Potsdam
Organization:
University of Potsdam
Study Overview
Official Title:
Stop the Pain-A Multicenter Randomized-controlled Study of a Cognitive-behavioral Intervention for Children With Functional Abdominal Pain
Status:
COMPLETED
Status Verified Date:
2018-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Stop-FAP
Brief Summary:
This trial aims to compare two training programs for children suffering functional abdominal pain These two programs are comparable in number of sessions and group sizes but show differences in content very focused on pain management vs more general information and support Focus of the trial is the evaluation of Stop the pain which has shown high effectiveness in one first trial This time five clinics experienced in diagnosis and treatment of childhood chronic abdominal pain will take part Children aged 7-12 years are eligible The programs imply six weekly group sessions for the children and 2 parent evenings The study group assumes that participation in Stop the pain will reduce pain experience and will improve the childrens quality of life and coping strategies - up to 12 months after training
Detailed Description:
The trial aims to assess the efficacy of a cognitive-behavioral self-management program intervention group IG compared to an equally extensive information-only control group CG The interventions contain 6 weekly group sessions and 2 parent meetings according to the cognitive-behavioral manualized program Stop the pain with Happy Pingu Follow up per patient 3- and 12 months Children aged 7-12 years suffering functional abdominal pain according to Rome III criteria H2a H2b H2d H2d1 are eligible Our primary hypothesis is that for patients in the IG the frequency and intensity of pain will be reduced more successfully and more sustainable than for children in the CG Secondary hypotheses state that the IG will experience a higher increase in quality of life and psychosocial well-being compared to the active CG
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| DRKS00005038 | REGISTRY | DRKS | None |