Patient Education in Children With Functional Gastrointestinal Disorders

December 16, 2021 updated by: Agneta Uusijärvi, Karolinska Institutet

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
25

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden, 17177
        • Karolinka Institutet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Baseline to 3 months.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pediatric Quality of Life Inventory Gastrointestinal Symptoms Scales (PedsQL Gastro)
Time Frame: Baseline to 3 months, baseline to 6 months.
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)
Time Frame: Baseline to 3 months, baseline to 6 months.
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)
Time Frame: Baseline to 3 months, baseline to 6 months.
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)
Time Frame: Baseline to 3 months, baseline to 6 months.
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)
Time Frame: Baseline to 3 months, baseline to 6 months.
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)
Time Frame: Baseline to 3 months, baseline to 6 months.
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)
Time Frame: Baseline to 3 months, baseline to 6 months.
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)
Time Frame: Baseline to 3 months, baseline to 6 months.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Karolinska Institutet

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Agneta Uusijärvi, MD PhD, Karolinska Institute, CLINTEC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 25, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 2, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 4, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 17, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 16, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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