Animal-assisted Therapy for Children and Adolescents With Chronic Pain

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04171336
• Other study ID #: AAT for CPP
• Status: Completed
• Phase: N/A
• Start date: September 5, 2020
• Est. completion date: May 2, 2021

Study information

• Verified date: May 2021
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: May 2, 2021
• Est. primary completion date: April 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Behavioral:
• Animal-assisted therapy
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.

Locations

Country	Name	City	State
Switzerland	Faculty of Psychology, University of Basel	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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