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Clinical Trials/NCT04171336
NCT04171336
Completed
Not Applicable

Animal-assisted Group Therapy for Children and Adolescents Suffering From Chronic Primary Pain

University Hospital, Basel, Switzerland1 site in 1 country3 target enrollmentSeptember 5, 2020
ConditionsChronic Pain

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Pain
Sponsor
University Hospital, Basel, Switzerland
Enrollment
3
Locations
1
Primary Endpoint
Pain Severity assessed by Visual Analogue Scale
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

Chronic pain is highly prevalent in children and adolescents, up to one in four children will develop pain that persists or recurs for three or more months. Chronic pain is not only linked to significant psychological, physical, and social concerns for affected children and their families, but also places an enormous burden on healthcare systems - in the United States, chronic pain costs around $19.5 billion dollars each year and ranks among the most expensive pediatric health problems. Chronic pain significantly decreases quality of life and is associated with numerous missing days at school or at work.

Several interventions exist, however, for some, the risk-benefit profile is not favorable, or the effect sizes are small and the clinical effect can be questioned. In general, a multidisciplinary approach that includes medical, psychological, and physiological aspects has been shown to be most promising in the treatment of chronic pain in children and adolescents.

Clinical impressions suggest that an Animal-assisted Therapy (AAT) intervention could be promising, but to the best of our knowledge, this is the first study to investigate the effectiveness of an AAT intervention for children and adolescents with chronic pain. With this pragmatic trials investigators aim to investigate the pre- and post-intervention differences in pain levels, levels of emotional distress, and quality of life within participants with chronic pain.

Registry
clinicaltrials.gov
Start Date
September 5, 2020
End Date
May 2, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
University Hospital, Basel, Switzerland
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Children and adolescents aged 8-15 years
  • Suffering from chronic pain (i.e., persistent or recurrent pain for 3 or more months, associated with significant emotional distress or functional limitations)
  • Willing to work with therapy animals
  • Fluent in German
  • Willingness to participate

Exclusion Criteria

  • children younger than 7 years or adolescents older than 16 years of age
  • Acute pain
  • Allergy to animals Aversion against animals

Outcomes

Primary Outcomes

Pain Severity assessed by Visual Analogue Scale

Time Frame: 6 weeks

Self-reported pain severity scored on a 0-10 scale, reported before and after each session. Higher scores indicate higher pain severity.

Pain Defocussing assessed by Visual Analogue Scale

Time Frame: 6 weeks

Self-reported pain defocussing scored on a 0-10 scale, reported before and after each session. Higher scores indicate more pain defocussing.

Pain Intensity assessed by Visual Analogue Scale

Time Frame: 12 weeks

Self-reported pain intensity scored on a 0-10 scale, reported before and after each session. Higher scores indicate higher pain intensity.

Pain Interference assessed by Visual Analogue Scale

Time Frame: 6 weeks

Self-reported pain interference scored on a 0-10 scale, reported before and after each session. Higher scores indicate more pain interference.

Pain Acceptance assessed by Visual Analogue Scale

Time Frame: 6 weeks

Self-reported pain acceptance scored on a 0-10 scale, reported before and after each session. Higher scores indicate more pain acceptance.

Study Sites (1)

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