Patient Education in Children and Adolescents With Pain-predominant Functional Gastrointestinal Disorders: a Pilot Study

Karolinska Institutet1 site in 1 country25 target enrollmentMay 1, 2020

ConditionsFunctional Gastrointestinal Disorders

Overview

Phase: N/A
Intervention: Not specified
Conditions: Functional Gastrointestinal Disorders
Sponsor: Karolinska Institutet
Enrollment: 25
Locations: 1
Primary Endpoint: Treatment acceptability
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This pilot-study aims to evaluate the effect size and feasibility of patient education for children and adolescents (age 8-17 years) with pain-predominant functional gastrointestinal disorders (irritable bowel syndrome, functional abdominal pain and functional dyspepsia according to the Rome III criteria).

Detailed Description

The patient education will be provided in a group setting and the children will participate along with one of their parents. Education consists of 2-hour long group sessions, given at 2 different occasions within a month. The hypothesis is that patient education will reduce gastrointestinal symptoms and pain and also improve quality of life in this group of patients.

Registry

clinicaltrials.gov

Start Date

May 1, 2020

End Date

December 1, 2021

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Karolinska Institutet

Responsible Party

Principal Investigator

Agneta Uusijärvi

Principal Investigator

Karolinska Institutet

Eligibility Criteria

Inclusion Criteria

•Children and adolescents between 8-17 years (until their 18th birthday) who have been diagnosed with any of the diagnoses irritable bowel syndrome, functional dyspepsia or functional abdominal pain according to the Rome III criteria.
•Blood samples, with normal outcome, in terms of complete blood count (CBC), Erythrocyte Sedimentation Rate (ESR), Anti-tissue Transglutaminase Antibody (tTG), and dipstick urinalysis. Faecal Calprotectin should be measured if diarrhea is present.

Exclusion Criteria

•Insufficient skills in the Swedish language.
•Severe psychiatric comorbidity (as suicidality, psychosis etc).
•Severe somatic comorbidity.

Outcomes

Primary Outcomes

Treatment acceptability

Time Frame: Baseline to 3 months.

A questionnaire to child /adolescent if they found the education logic. If they believe it will decrease symptoms. If they would recommend it to others

Secondary Outcomes

Rome IV Diagnostic Questionnaire on Pediatric Functional Gastrointestinal Disorders (R4PDQ)(Baseline to 3 months, baseline to 6 months.)
Spence Children Anxiety Scale - short version (SCAS-S)(Baseline to 3 months, baseline to 6 months.)
Children's Somatization Inventory (CSI-24) - subscale for gastrointestinal symptoms (CSI gastro)(Baseline to 3 months, baseline to 6 months.)
Pediatric Quality of Life Inventory (PedsQL)(Baseline to 3 months, baseline to 6 months.)
The behavioral responses questionnaire child-adapted short scale (BRQ-C)(Baseline to 3 months, baseline to 6 months.)
Pediatric Quality of Life Inventory Gastrointestinal Symptoms Scales (PedsQL Gastro)(Baseline to 3 months, baseline to 6 months.)
Faces Pain Rating Scale. (FACES)(Baseline to 3 months, baseline to 6 months.)
Child Depression Inventory - short version (CDI-S)(Baseline to 3 months, baseline to 6 months.)