Skip to main content
OpenTrials
Completed

NCT Number: NCT04171336

Animal-assisted Therapy for Children and Adolescents With Chronic Pain

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

8 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Psychology, University of Basel

Basel, 40555, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Animal-assisted Therapy

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 20, 2019
Registry last updated
May 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.