A cognitive behavioural treatment programme for children with chronic abdominal pain
| ISRCTN | ISRCTN69830258 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN69830258 |
| Secondary identifying numbers | N/A |
- Submission date
- 15/09/2009
- Registration date
- 03/11/2009
- Last edited
- 29/12/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Ms Martina Gross
Scientific
Scientific
Karl-Liebknecht-Str. 24-25
Potsdam
14476
Germany
| Phone | +49 (0)331 977 2892 |
|---|---|
| martina.gross@uni-potsdam.de |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Evaluation of a cognitive behavioural treatment programme for children with chronic abdominal pain: a ranomised controlled trial |
| Study acronym | STOPCAP |
| Study objectives | The main goal of the study is to investigate if the cognitive behavioural treatment ('Stop the Pain') is able to decrease the frequency and intensity of pain symptoms as well as to increase the quality of life as compared to 'wait-list-controls' (control group [CG]). The main hypothesis is that the treatment group (EG) will experience an improvement in pain-related coping skills and pain-related cognitions in comparison to the CG. Publication on the pilot study (in German): Warschburger, P. & Gross, M. (2008). "Stopp den Schmerz" ein kognitiv-behaviorales Behandlungsprogramm für Kinder mit Bauchschmerzen. Erste Ergebnisse einer Pilotstudie. Verhaltenstherapie, 18, 162-167. |
| Ethics approval(s) | Ethics Committee of the University of Potsdam, 11/06/2008 |
| Health condition(s) or problem(s) studied | Chronic abdominal pain |
| Intervention | The developed and pilot-tested cognitive-behavioural treatment programme includes the following: For children: 1. Guided relaxation 2. Information on CAP 3. Coping strategies 4. Altering negative cognitions Children attend at least 6 weekly sessions (90 minutes each). The courses will be taught by psychologists. For adults: 1. Information on the etiology and maintenance of CAP 2. How to support their child in pain-related coping Adults attend one 2-hour training session. The course will be taught by psychologists and nutritionists. The control group will receive only usual care during the interventions. They will have the opportunity to receive the same interventions once the trial has been completed. |
| Intervention type | Other |
| Primary outcome measure | 1. Abdominal pain (frequency and intensity). Intensity of pain is measured using the Visual Analogue Scale (VAS) score (0 = no pain, 10 = unbearable pain). 2. Qualitty of life: 2.1. Quality of Life Inventory™ (PedsQL™) 2.2. Generic children's health-related quality of life (KINDL-R) All primary and secondary outcomes will be measured at baseline, post-interventions and 3-month follow-up. |
| Secondary outcome measures | 1. Coping with pain, assessed by PedsQL™ Pediatric Pain Coping Inventory (PedsQL™-PPCI) 2. Stress vulnerability (scale of SSKJ 3-8, Fragebogen zur Erhebung von Stress und Stressbewältigung im Kindes- und Jugendalter) All primary and secondary outcomes will be measured at baseline, post-interventions and 3-month follow-up. |
| Overall study start date | 01/08/2008 |
| Completion date | 31/12/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 8 Years |
| Upper age limit | 12 Years |
| Sex | Both |
| Target number of participants | 28 |
| Total final enrolment | 29 |
| Key inclusion criteria | 1. Age: 8-12 years, either sex 2. Informed consent (parent and children) to participate in the study 3. Children must have suffered from abdominal pain for at least three months 4. Pain occurs frequently (once a week), episodes of pain are severe enough to affect the child's activities |
| Key exclusion criteria | 1. Previous participation in a similar intervention for chronic abdominal pain (CAP) 2. CAP as a consequence of psychiatric disorders (e.g. depression, anxiety disorder) |
| Date of first enrolment | 01/08/2008 |
| Date of final enrolment | 31/12/2009 |
Locations
Countries of recruitment
- Germany
Study participating centre
Karl-Liebknecht-Str. 24-25
Potsdam
14476
Germany
14476
Germany
Sponsor information
University of Potsdam (Germany)
Government
Government
Potsdam Graduate School
Am Neuen Palais 10
Haus 2
Potsdam
14469
Germany
| Phone | +49 331 977 1855 |
|---|---|
| pogs@uni-potsdam.de | |
| Website | http://www.uni-potsdam.de/ |
"ROR" |
https://ror.org/03bnmw459 |
Funders
Funder type
Government
Department of Science, Research and Culture of the State of Brandenburg (Germany) - scholarship
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/09/2013 | 29/12/2020 | Yes | No |
Editorial Notes
29/12/2020: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
