Clinical trial NCT04171336: Animal-assisted Therapy for Children and Adolescents With Chronic Pain
Official title: Animal-assisted Group Therapy for Children and Adolescents Suffering From Chronic Primary Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2019-11-20
Enrollment: 3
Sex: ALL
Minimum age (years): 8
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pragmatic trial
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Pain Intensity assessed by Visual Analogue Scale
timeFrame: 12 weeks
measure: Pain Severity assessed by Visual Analogue Scale
timeFrame: 6 weeks
measure: Pain Interference assessed by Visual Analogue Scale
timeFrame: 6 weeks
measure: Pain Acceptance assessed by Visual Analogue Scale
timeFrame: 6 weeks
measure: Pain Defocussing assessed by Visual Analogue Scale
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Faculty of Psychology, University of Basel
Study officials:
affiliation: Faculty of Psychology, University of Basel, Switzerland
name: Helen Koechlin, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty of Psychology, University of Basel, Switzerland
name: Cosima Locher, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty of Psychology, University of Basel, Switzerland
name: Jens Gaab, Prof Dr
role: PRINCIPAL_INVESTIGATOR
References: