Patient Education in Children With Functional Gastrointestinal Disorders

Functional Gastrointestinal Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04294420
• Other study ID #: 2019-05417
• Status: Completed
• Phase: N/A
• Start date: May 1, 2020
• Est. completion date: December 1, 2021

Study information

• Verified date: December 2021
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: December 1, 2021
• Est. primary completion date: May 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Digestive System Diseases
• Functional Gastrointestinal Disorders
• Gastrointestinal Diseases

Intervention

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.

Locations

Country	Name	City	State
Sweden	Karolinka Institutet	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.