Patient Education in Children With Functional Gastrointestinal Disorders

NCT04294420 | Completed

• 1 other identifier: 2019-05417
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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).

Conditions

Functional Gastrointestinal Disorders

Outcome Measures

Primary Outcomes (1)

• Treatment acceptability

  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

  Baseline to 3 months.

Secondary Outcomes (8)

• Pediatric Quality of Life Inventory Gastrointestinal Symptoms Scales (PedsQL Gastro)

  Baseline to 3 months, baseline to 6 months.

• Rome IV Diagnostic Questionnaire on Pediatric Functional Gastrointestinal Disorders (R4PDQ)

  Baseline to 3 months, baseline to 6 months.

• Faces Pain Rating Scale. (FACES)

  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.

Study Arms (1)

Patient education program

EXPERIMENTAL

Patient education program

Behavioral: Patient education program

Interventions

Patient education program BEHAVIORAL

The education program provides information and guidance concerning aetiology, diagnostics and treatment of pain-predominant functional gastrointestinal disorders. The patient education program will be provided in a group setting and the children will participate along with one of their parents. The participants (n=20) will be divided into two groups consisting of ten child-parent pairs. Two lectures will be held, two weeks apart, two hours per lecture. Represented teachers are physician, psychologist and dietician.

Patient education program

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Karolinka Institutet

Stockholm, 17177, Sweden

Location

MeSH Terms

Conditions

Gastrointestinal Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

• Agneta Uusijärvi, MD PhD

  Karolinska Institute, CLINTEC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 25, 2020
• First Posted: March 4, 2020
• Study Start: May 1, 2020
• Primary Completion: May 1, 2021
• Study Completion: December 1, 2021
• Last Updated: December 17, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)