Animal-assisted Therapy for Children and Adolescents With Chronic Pain

NCT04171336 | Completed

• 1 other identifier: AAT for CPP
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (1)

Animal-assisted group therapy

EXPERIMENTAL

Behavioral: Animal-assisted therapy

Interventions

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.

Animal-assisted group therapy

Eligibility Criteria

• Age: 8 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

Faculty of Psychology, University of Basel

Basel, 40555, Switzerland

Location

Related Publications (1)

• Locher C, Petignat M, Wagner C, Hediger K, Roth B, Gaab J, Koechlin H. Animal-Assisted Psychotherapy for Pediatric Chronic Pain: Case Series of an Open Pilot Study to Test Initial Feasibility and Potential Efficacy. J Pain Res. 2023 May 29;16:1799-1811. doi: 10.2147/JPR.S394270. eCollection 2023.

  PMID: 37273273 DERIVED

MeSH Terms

Conditions

Chronic Pain

Interventions

Animal Assisted Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Psychotherapy; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Helen Koechlin, PhD

  Faculty of Psychology, University of Basel, Switzerland

  PRINCIPAL INVESTIGATOR

• Cosima Locher, PhD

  Faculty of Psychology, University of Basel, Switzerland

  PRINCIPAL INVESTIGATOR

• Jens Gaab, Prof Dr

  Faculty of Psychology, University of Basel, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pragmatic trial

Study Record Dates

• First Submitted: November 14, 2019
• First Posted: November 20, 2019
• Study Start: September 5, 2020
• Primary Completion: April 10, 2021
• Study Completion: May 2, 2021
• Last Updated: May 18, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will share

Locations

CH (1)