Animal-assisted Therapy for Children and Adolescents With Chronic Pain

Study Overview
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Brief Summary
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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.

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

Conditions
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Chronic Pain

Intervention / Treatment
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* Behavioral: Animal-assisted therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Pragmatic trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Animal-assisted group therapy<br> | Behavioral: Animal-assisted therapy<br>* Six sessions of animal-assisted intervention for children and adolescents, group format. The sessions will focus on psycho-education on pain, mindfulness, defocusing, getting active, and resources. Additionally, the intervention includes two family visits.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Intensity assessed by Visual Analogue Scale | Self-reported pain intensity scored on a 0-10 scale, reported before and after each session. Higher scores indicate higher pain intensity. | 12 weeks | 
| Pain Severity assessed by Visual Analogue Scale | Self-reported pain severity scored on a 0-10 scale, reported before and after each session. Higher scores indicate higher pain severity. | 6 weeks | 
| Pain Interference assessed by Visual Analogue Scale | Self-reported pain interference scored on a 0-10 scale, reported before and after each session. Higher scores indicate more pain interference. | 6 weeks | 
| Pain Acceptance assessed by Visual Analogue Scale | Self-reported pain acceptance scored on a 0-10 scale, reported before and after each session. Higher scores indicate more pain acceptance. | 6 weeks | 
| Pain Defocussing assessed by Visual Analogue Scale | Self-reported pain defocussing scored on a 0-10 scale, reported before and after each session. Higher scores indicate more pain defocussing. | 6 weeks |