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Clinical Trials/NCT05945251
NCT05945251
Recruiting
Not Applicable

Individualized Online Cognitive Behavioral Therapy for Children With Functional Abdominal Pain Disorders - the Child's Pain Regulation

Karolinska Institutet1 site in 1 country80 target enrollmentNovember 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Functional Abdominal Pain Syndrome
Sponsor
Karolinska Institutet
Enrollment
80
Locations
1
Primary Endpoint
Unpleasantness of pressure pain threshold on navel
Status
Recruiting
Last Updated
8 months ago

Overview

Brief Summary

Functional abdominal pain disorders (FAPDs) in children are common (14%) and abdominal pain has increased rapidly in children during the last ten years in Sweden. Many children with FAPDs have low quality of life, missed school days, and about 30-40% suffer from psychiatric comorbidity. FAPDs are often sustained into adulthood and a large Swedish cohort study showed that abdominal pain during childhood is an independent strong predictor anxiety and depression later in life. Internet-cognitive behavioral therapy (Internet-CBT) can improve FAPD symptoms, but a significant number of children does not respond to the treatment.

We will here determine the pain regulation in children with FAPDs, compared with healthy controls, and assess:

What aspects of the child's pain regulation is related to improvement for children with FAPDs engaging in Internet-CBT?

Does some aspects of the child's pain regulation change during treatment?

Registry
clinicaltrials.gov
Start Date
November 1, 2023
End Date
January 1, 2026
Last Updated
8 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Maria Lalouni

Assistant Professor

Karolinska Institutet

Eligibility Criteria

Inclusion Criteria

  • Children 8-17 years with FAPDs: Have been offered treatment at BUP Internetbehandling for FAPDs.
  • Children 8-17 years without FAPDs: Not affected by recurrent (every week) or persistant pain during the last year.

Exclusion Criteria

  • Contraindication for MR (metal implant or metal object in body, claustrophobia, pregnancy)

Outcomes

Primary Outcomes

Unpleasantness of pressure pain threshold on navel

Time Frame: Baseline differences and baseline to follow-up after 10 week's treatment (or 10 week's wait for healthy children)

Children rate their unpleasantness on a scale 0-10

Pressure pain threshold on navel

Time Frame: Baseline differences and baseline to follow-up after 10 week's treatment (or 10 week's wait for healthy children)

Algometer pressure (in kPa) for the pain threshold

Secondary Outcomes

  • Conditioned pain modulation(Baseline differences and baseline to follow-up after 10 week's treatment (or 10 week's wait for healthy children))
  • Irritable bowel syndrome-behavioral responses questionnaire, child-adapted short version (BRQ-C)(Baseline differences and baseline to follow-up after 10 week's treatment (or 10 week's wait for healthy children))
  • Unpleasantness of pressure pain threshold on thigh(Baseline differences and baseline to follow-up after 10 week's treatment (or 10 week's wait for healthy children))
  • Sensory attenuation of pain(Baseline differences and baseline to follow-up after 10 week's treatment (or 10 week's wait for healthy children))
  • Visceral sensitivity Index, child-adapted short version (VSI-C)(Baseline differences and baseline to follow-up after 10 week's treatment (or 10 week's wait for healthy children))
  • Temporal summation(Baseline differences and baseline to follow-up after 10 week's treatment (or 10 week's wait for healthy children))
  • Resting state fMRI(Baseline differences and baseline to follow-up after 10 week's treatment (or 10 week's wait for healthy children))
  • Pediatric Quality of Life Inventory Gastrointestinal Symptom Scale (PedsQL Gastro)(Baseline differences and baseline to follow-up after 10 week's treatment (or 10 week's wait for healthy children))
  • Faces Pain Rating Scale (FACES)(Baseline differences and baseline to follow-up after 10 week's treatment (or 10 week's wait for healthy children))
  • Pressure pain threshold on thigh(Baseline differences and baseline to follow-up after 10 week's treatment (or 10 week's wait for healthy children))
  • fMRI during low pain compared with non-painful tactile stimulus(Baseline differences and baseline to follow-up after 10 week's treatment (or 10 week's wait for healthy children))

Study Sites (1)

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