StoMakker: Improving the Quality of Life of Children Receiving an Ileostomy, Colostomy or Continent Urostomy by Offering Access to a Peer Support Platform, Age Dependent Information Provision and Games in a Smartphone Application
Abstract
The goal of this clinical trial is to investigate if access to the StoMakker application will significantly improve health-related quality of life in children receiving surgery resulting in an ileostomy, colostomy or continent urostomy. The main question it aims to answer are:
* Does access to StoMakker improve health-related quality of life in children receiving surgery for an ostomy?
* Does access to StoMakker improve the anxiety and social functioning of children receiving surgery for an ostomy?
* Does access to StoMakker improve postoperative complications of children receiving surgery for an ostomy?
Participants will be asked to fill in several questionnaires around their surgery. The intervention group of the trial will be given access to the application "StoMakker". The control group of the trial will receive standard care.
Conditions: Inflammatory Bowel Diseases, Anorectal Malformations, Spina Bifida, Ostomy.
Primary outcome: Change from baseline in health-related quality of life of participants on the age specific 7 item PROMIS Pediatric Global Health scale (PGH-7) questionnaire at 6 months after surgery.
Enrollment: 30 participants.
How strong is the evidence?
Evidence Hub reads this as a clinical trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 30 participants or records.
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