Clinical trial NCT04294420: Patient Education in Children With Functional Gastrointestinal Disorders
Official title: Patient Education in Children and Adolescents With Pain-predominant Functional Gastrointestinal Disorders: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Functional Gastrointestinal Disorders
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2020-03-04
Enrollment: 25
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Treatment acceptability
timeFrame: Baseline to 3 months.
Secondary outcomes:
measure: Pediatric Quality of Life Inventory Gastrointestinal Symptoms Scales (PedsQL Gastro)
timeFrame: Baseline to 3 months, baseline to 6 months.
measure: Rome IV Diagnostic Questionnaire on Pediatric Functional Gastrointestinal Disorders (R4PDQ)
timeFrame: Baseline to 3 months, baseline to 6 months.
measure: Faces Pain Rating Scale. (FACES)
timeFrame: Baseline to 3 months, baseline to 6 months.
measure: Pediatric Quality of Life Inventory (PedsQL)
timeFrame: Baseline to 3 months, baseline to 6 months.
measure: The behavioral responses questionnaire child-adapted short scale (BRQ-C)
timeFrame: Baseline to 3 months, baseline to 6 months.
measure: Children's Somatization Inventory (CSI-24) - subscale for gastrointestinal symptoms (CSI gastro)
timeFrame: Baseline to 3 months, baseline to 6 months.
measure: Spence Children Anxiety Scale - short version (SCAS-S)
timeFrame: Baseline to 3 months, baseline to 6 months.
measure: Child Depression Inventory - short version (CDI-S)
timeFrame: Baseline to 3 months, baseline to 6 months.
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinka Institutet
Study officials:
affiliation: Karolinska Institute, CLINTEC
name: Agneta Uusijärvi, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: