Animal-assisted Therapy for Children and Adolescents With Chronic Pain
Primary Purpose
Chronic Pain
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Animal-assisted therapy
Sponsored by
About this trial
This is an interventional treatment trial for 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
Sites / Locations
- Faculty of Psychology, University of Basel
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Animal-assisted group therapy
Arm Description
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04171336
First Posted
November 14, 2019
Last Updated
May 17, 2021
Sponsor
University Hospital, Basel, Switzerland
1. Study Identification
Unique Protocol Identification Number
NCT04171336
Brief Title
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
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
September 5, 2020 (Actual)
Primary Completion Date
April 10, 2021 (Actual)
Study Completion Date
May 2, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Basel, Switzerland
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Pragmatic trial
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Animal-assisted group therapy
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Animal-assisted therapy
Intervention Description
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 Outcome Measure Information:
Title
Pain Intensity assessed by Visual Analogue Scale
Description
Self-reported pain intensity scored on a 0-10 scale, reported before and after each session. Higher scores indicate higher pain intensity.
Time Frame
12 weeks
Title
Pain Severity assessed by Visual Analogue Scale
Description
Self-reported pain severity scored on a 0-10 scale, reported before and after each session. Higher scores indicate higher pain severity.
Time Frame
6 weeks
Title
Pain Interference assessed by Visual Analogue Scale
Description
Self-reported pain interference scored on a 0-10 scale, reported before and after each session. Higher scores indicate more pain interference.
Time Frame
6 weeks
Title
Pain Acceptance assessed by Visual Analogue Scale
Description
Self-reported pain acceptance scored on a 0-10 scale, reported before and after each session. Higher scores indicate more pain acceptance.
Time Frame
6 weeks
Title
Pain Defocussing assessed by Visual Analogue Scale
Description
Self-reported pain defocussing scored on a 0-10 scale, reported before and after each session. Higher scores indicate more pain defocussing.
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helen Koechlin, PhD
Organizational Affiliation
Faculty of Psychology, University of Basel, Switzerland
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Cosima Locher, PhD
Organizational Affiliation
Faculty of Psychology, University of Basel, Switzerland
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jens Gaab, Prof Dr
Organizational Affiliation
Faculty of Psychology, University of Basel, Switzerland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Psychology, University of Basel
City
Basel
ZIP/Postal Code
40555
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Animal-assisted Therapy for Children and Adolescents With Chronic Pain
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