Patient Education in Children With Functional Gastrointestinal Disorders

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

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).

Study Overview

• Status: Completed
• Conditions: Functional Gastrointestinal Disorders
• Intervention / Treatment: Behavioral: Patient education program

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.

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden, 17177
    • Karolinka Institutet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Patient education program

Behavioral: Patient education program; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pediatric Quality of Life Inventory Gastrointestinal Symptoms Scales (PedsQL Gastro)	Change in gastrointestinal symptoms measured with with a 14-item scale ranging from 0 (never) to 4 (almost always) measured from baseline to three months and from baseline to six months for analysis of effect. Improvements yield increased values.	Baseline to 3 months, baseline to 6 months.
Rome IV Diagnostic Questionnaire on Pediatric Functional Gastrointestinal Disorders (R4PDQ)	Change in children's functional gastrointestinal disorders diagnostic status measured by Rome IV Diagnostic Questionnaire on Pediatric Functional Gastrointestinal Disorders (R4PDQ) - Child: Non-numerical self-report form for Children and Adolescents (10 years and older) measured from baseline to three months and from baseline to six months for analysis of effect as a self-rating scale from baseline to three months and from baseline to six months for analysis of effect.	Baseline to 3 months, baseline to 6 months.
Faces Pain Rating Scale. (FACES)	Change in pain intensity measured with a self-rating scale daily during two weeks at baseline, daily during two weeks after 3 months and daily during two weeks after 6 months for analysis of effect. The Faces Pain Scale is a self-report measure used to assess the intensity of children's pain. Faces have four faces representing least pain and most pain on equal intervals on a scale from 0 (no pain)-10 (worst pain). Its validity is supported by a strong positive correlation (r=0.93, N=76) with a visual analogue scale (VAS) measure in children aged 5-12 years. The metric for scoring (0-10) conforms closely to a linear interval scale.Higher scores indicates higher levels of pain.	Baseline to 3 months, baseline to 6 months.
Pediatric Quality of Life Inventory (PedsQL)	Change in quality of life from baseline to three months and from baseline to six months measured with a self-report scale that measures quality of life in adolescents. PedsQL Generic Core scales is a 23-item scale ranging from 0 (never) to 4 (almost always). Improvements yield increased values. The PedsQL is shown to distinguish between healthy children and adolescents and pediatric patients with acute or chronic health conditions and demonstrate acceptable reliability and validity.	Baseline to 3 months, baseline to 6 months.
The behavioral responses questionnaire child-adapted short scale (BRQ-C)	Change in Gastrointestinal symptom-specific behaviors measured with a self-rating scale from baseline to three months and from baseline to 6 months, for analysis of effect. The BRQ-C comprise 11 items on a 7 point-scale, with only endpoints defined: never (0) and always (7). Higher scores indicates higher levels of gastrointestinal symptoms.	Baseline to 3 months, baseline to 6 months.
Children's Somatization Inventory (CSI-24) - subscale for gastrointestinal symptoms (CSI gastro)	A questionnaire that assesses the perceived severity of 24 nonspecific somatic symptoms. Items are based off of the symptom criteria for somatization disorders as defined by the Diagnostic and Statistical Manual of Mental Disorders (DSM). We will use the subscale for gastrointestinal symptoms (CSI gastro) with questions concerning presence of gastrointestinal symptoms measured with a 7-item scale ranging from 0 (not at all) to 4 (very much) measured from baseline to three months and from baseline to six months. Higher scores indicates higher levels of somatization.	Baseline to 3 months, baseline to 6 months.
Spence Children Anxiety Scale - short version (SCAS-S)	The SCAS-S assesses anxiety in children. The frequency of anxiety symptoms is rated on a 4-point scale, with answers ranging from never (0) to always (3). Higher scores indicates higher levels of anxiety. The SCAS-S will be assessed from baseline to three months and from baseline to six months.	Baseline to 3 months, baseline to 6 months.
Child Depression Inventory - short version (CDI-S)	Child Depression Inventory (CDI) is a self-measure of child depression symptoms. The short version of the CDI (CDI-S) consists of 10 items graded from 0 (no symptoms) to 2 (severe symptoms). The questionnaire covers depressive symptoms such as self-blame, loss of appetite and insomnia. The CDI-S has shown high correlation to other measures of depression and should be considered a valid measure of depression symptoms. Symptoms measured from baseline to three months and from baseline to six months. Higher scores indicates higher levels of depression.	Baseline to 3 months, baseline to 6 months.

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Investigators: Principal Investigator: Agneta Uusijärvi, MD PhD, Karolinska Institute, CLINTEC

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2020
• Primary Completion (Actual): May 1, 2021
• Study Completion (Actual): December 1, 2021

Study Registration Dates

• First Submitted: February 25, 2020
• First Submitted That Met QC Criteria: March 2, 2020
• First Posted (Actual): March 4, 2020

Study Record Updates

• Last Update Posted (Actual): December 17, 2021
• Last Update Submitted That Met QC Criteria: December 16, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Gastrointestinal Diseases; Digestive System Diseases
• Other Study ID Numbers: 2019-05417

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No