AnxietyCANINE IIINCT03784573
Canine-Assisted Anxiety Reduction In Emergency Care
A study testing Dog + handler and No dog in people with Anxiety and Opioid Use, run by Indiana University at 1 site in United States.
Trial summary
Compare the effect of a single exposure to a therapy dog and handler within the pediatric emergency department patient with anxiety by measuring the change in patient perception of anxiety before and after dog exposure using the FACES scale. Read more about this study
- Who is it for?
- Ages 4 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Opioid Use, Children
- What is being tested?
- Dog + handler and No dog
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jan 2019to 30 Jun 2024
- 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 4 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 4-17 years old;
- Physician or nurse with primary care responsibilities believes that the patients has a moderate to high level of anxiety
Who cannot join
- violent behavior and any reported prior fear or adverse reaction to dogs in the dog intervention group.
Trial locations and contacts
1 site in 1 country.
United States1 site
IU Health Riley Children's Hospital
Indianapolis, Indiana, 46202
About this study
Compare the effect of a single exposure to a therapy dog and handler within the pediatric emergency department patient with anxiety by measuring the change in patient perception of anxiety before and after dog exposure using the FACES scale. We will also measure galvanic skin response (resistance to electrical current).
Read the detailed description
This study challenges current dogma by introducing a widely available, low cost method of dog therapy to reduce patient stress. The organization "Paws of Love" estimates that it has 180,000 volunteers who have qualified therapy dogs and who are generally willing to volunteer their time in emergency care. The benefits may include improved perception of wellness, less opioid use, and decreased use of physical and chemical restraints. As a further extrapolation, this secondary effect may extend to improved patient-doctor communication and patient experience. This will in turn improve patient safety in the Emergency Department, decreasing the number of adverse events, and decreasing the risk of medical malpractice by improving the patient-provider relationship. (6, 7)
- Conditions
- Anxiety, Opioid Use, Children, Therapy Dog
- Being tested
- Dog + handler, No dog
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dog + handlerBehavioural
Dog + handler
No dogBehavioural
No dog
| Study group | Role | What they receive |
|---|---|---|
| Dog + handler | Active comparator | Not described Receives: Behavioral: Dog + handler |
| No dog | Placebo comparator | Not described Receives: Behavioral: No dog |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in anxiety level of subject
Change in anxiety level of subject with the use of the FACES scale
Measured: 45 minutes
Secondary outcomes (6)
Perception of anxiety level from physician
Change in perception anxiety level of subject with the use of the FACES scale
Measured: 60 minutes
Perception of pain level from physician
Change in perception of pain level of subject with the use of a Wong-Baker Faces pain scale
Measured: 60 minutes
Perception of anxiety level from parent(s)
Change in perception of anxiety level of subject by their parent(s) with the use of the FACES scale
Measured: 60 minutes
Perception of pain level from parent(s)
Change in perception of pain level of subject by the parent(s) with the use of a Wong-Baker Faces pain scale
Measured: 60 minutes
Meds
Number of medications used to reduce anxiety in the different arms
Measured: 4 hours
Physical restrain use
Number of times physical restraints are used
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2018
- Study start7 Jan 2019
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
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 AnxietyStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Subjects will be randomized per dog and handler availability, but subjects that are excluded due to an aversion or dogs or per the Child Life staff member, can be in the control group.
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heather Kelker, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03784573
- Sponsor's protocol ID
- 1811186507
- Acronym
- CANINE III
- Status last verified
- Jul 2024
- First submitted
- 17 Dec 2018
- Last updated
- 17 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kelker HP, Siddiqui HK, Beck AM, Kline JA. Therapy Dogs for Anxiety in Children in the Emergency Department: A Randomized Clinical Trial. JAMA Netw Open. 2025 Mar 3;8(3):e250636. doi: 10.1001/jamanetworkopen.2025.0636.
PubMed 40085085
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Canine-Assisted Anxiety Reduction In Emergency Care
- ClinicalTrials.gov ID
- NCT03784573
- Acronym / sponsor ID
- CANINE III / 1811186507
- Conditions
- Anxiety, Opioid Use, Children, Therapy Dog
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 7 Jan 2019 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 24 Dec 2018 (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.
Compare the effect of a single exposure to a therapy dog and handler within the pediatric emergency department patient with anxiety by measuring the change in patient perception of anxiety before and after dog exposure using the FACES scale. We will also measure galvanic skin response (resistance to electrical current).
Detailed description
This study challenges current dogma by introducing a widely available, low cost method of dog therapy to reduce patient stress. The organization "Paws of Love" estimates that it has 180,000 volunteers who have qualified therapy dogs and who are generally willing to volunteer their time in emergency care. The benefits may include improved perception of wellness, less opioid use, and decreased use of physical and chemical restraints. As a further extrapolation, this secondary effect may extend to improved patient-doctor communication and patient experience. This will in turn improve patient safety in the Emergency Department, decreasing the number of adverse events, and decreasing the risk of medical malpractice by improving the patient-provider relationship. (6, 7)
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Subjects will be randomized per dog and handler availability, but subjects that are excluded due to an aversion or dogs or per the Child Life staff member, can be in the control group.
| Arm | Type | Receives |
|---|---|---|
| Dog + handler | Active comparator | Behavioral: Dog + handler |
| No dog | Placebo comparator | Behavioral: No dog |
Who may qualify
- Ages
- 4 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 4-17 years old;
- Physician or nurse with primary care responsibilities believes that the patients has a moderate to high level of anxiety
Key exclusion criteria (1 listed)
- violent behavior and any reported prior fear or adverse reaction to dogs in the dog intervention group.
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 |
|---|---|---|
| Dog + handlerDog + handler | Behavioural | Dog + handler |
| No dogNo dog | Behavioural | No dog |
Primary outcome
Change in anxiety level of subject
Time frame: 45 minutes
Change in anxiety level of subject with the use of the FACES scale
6 secondary outcomes
Perception of anxiety level from physician
Time frame: 60 minutes
Perception of pain level from physician
Time frame: 60 minutes
Perception of anxiety level from parent(s)
Time frame: 60 minutes
Perception of pain level from parent(s)
Time frame: 60 minutes
Meds
Time frame: 4 hours
Physical restrain use
Time frame: 4 hours
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 17 Jul 2024.
- Derived from this study: PubMed 40085085Kelker HP, Siddiqui HK, Beck AM, Kline JA. Therapy Dogs for Anxiety in Children in the Emergency Department: A Randomized Clinical Trial. JAMA Netw Open. 2025 Mar 3;8(3):e250636. doi: 10.1001/jamanetworkopen.2025.0636.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dog + handler and No dog in people with Anxiety and Opioid Use, run by Indiana University at 1 site in United States.
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 2 inclusion and 1 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 17 Jul 2024. 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 United States. 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. Some participants in this study may receive a placebo. 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?
Change in anxiety level of subject (time frame: 45 minutes). 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 NCT03784573, 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 17 Jul 2024.