Chronic PainNCT04171336
Animal-assisted Therapy for Children and Adolescents With Chronic Pain
A study testing Animal-assisted therapy in people with Chronic Pain, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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… Read more about this study
- Who is it for?
- Ages 8 to 16 years
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Animal-assisted therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteSwitzerland
- Study dates
- 5 Sep 2020to 2 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- children younger than 7 years or adolescents older than 16 years of age
- Acute pain
- Allergy to animals Aversion against animals
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Animal-assisted Group Therapy for Children and Adolescents Suffering From Chronic Primary 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.
- Conditions
- Chronic Pain
- Being tested
- Animal-assisted therapy
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Animal-assisted therapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Animal-assisted group therapy | Experimental | Not described Receives: Behavioral: Animal-assisted therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2019
- Study start5 Sep 2020
- Primary completion10 Apr 2021
- Study completion2 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pragmatic trial
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Helen Koechlin, PhD, Principal investigator, Faculty of Psychology, University of Basel, SwitzerlandCosima Locher, PhD, Principal investigator, Faculty of Psychology, University of Basel, SwitzerlandJens Gaab, Prof Dr, Principal investigator, Faculty of Psychology, University of Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04171336
- Sponsor's protocol ID
- AAT for CPP
- Status last verified
- May 2021
- First submitted
- 14 Nov 2019
- Last updated
- 18 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 37273273
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Animal-assisted Group Therapy for Children and Adolescents Suffering From Chronic Primary Pain
- ClinicalTrials.gov ID
- NCT04171336
- Acronym / sponsor ID
- AAT for CPP
- Conditions
- Chronic Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 5 Sep 2020 (actual)
- Primary completion
- 10 Apr 2021 (actual)
- Study completion
- 2 May 2021 (actual)
- First posted
- 20 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pragmatic trial
| Arm | Type | Receives |
|---|---|---|
| Animal-assisted group therapy | Experimental | Behavioral: Animal-assisted therapy |
Who may qualify
- Ages
- 8 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- children younger than 7 years or adolescents older than 16 years of age
- Acute pain
- Allergy to animals Aversion against animals
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Animal-assisted therapySix 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. | Behavioural | Animal-assisted group therapy |
Primary outcome
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2021.
- Derived from this study: PubMed 37273273Locher 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Helen Koechlin, PhD principal investigator
Faculty of Psychology, University of Basel, Switzerland
Cosima Locher, PhD principal investigator
Faculty of Psychology, University of Basel, Switzerland
Jens Gaab, Prof Dr principal investigator
Faculty of Psychology, University of Basel, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Animal-assisted therapy in people with Chronic Pain, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity assessed by Visual Analogue Scale (time frame: 12 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04171336, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2021.