AnxietyCANINENCT03471429
Canine-assisted ANxiety Reduction IN Emergency
An observational study of Anxiety, run by Indiana University at 1 site in United States.
Trial summary
The purpose of this study is to see if dogs can reduce the anxiety level of patients in the emergency department. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Anxiety
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Dec 2017to 4 Apr 2018
- Phase
- Observational
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients enrolled from Emergency Department that are 18 or older with moderate or greater anxiety, per physician Gestalt.
Who may be able to join
- Research staff will screen for inclusion criterion by asking the care providers if they agree with this statement, "I believe this patient is experiencing moderate or greater anxiety".
Who cannot join
- Extreme intoxication, agitation that precludes conversation with the patient, fear of dogs, dog bite, allergy to dogs.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to see if dogs can reduce the anxiety level of patients in the emergency department.
Read the detailed description
Patients will score their pain, anxiety, and depression. A dog will then come into the patient's room for approximately 15 minutes after which the patient will score his/her pain, anxiety, and depression again.
- Conditions
- Anxiety
- Keywords
- Anxiety, Dog, Canine, Therapy, Depression, Pain
- Medical subject headings
- Anxiety Disorders, Depression, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Dog | Patient sees therapy dog for 15 minutes, which is standard of care at this hospital. | |
| No Dog | Patient receives standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety reduction from Scale
reduction in anxiety score (0-10). 0=balanced mood (least anxiety) 2= slight fear and worry 4=mild fear and worry 6= moderate worry, physical agitation 8=Feeling really bad, at the edge 10=out of control behavior, self-harm (worst anxiety)
Measured: 30 mins
Secondary outcomes (2)
Pain reduction from Wong Baker faces scale
reduction in pain score (0-10). 0=no hurt (least pain) 2= Hurts little bit 4= Hurts little more 6= Hurts even more 8= Hurts whole lot 10=out of control behavior, self-harm (hurts worst)
Measured: 30 mins
Depression reduction from scale
reduction in depression score (0-10). 0= Balanced mood (least depressed) 2= Slightly depressed 4= Mildly depressed 6= Definite malaise 8= Feeling reall bad, at the edge 10=Despair, suicidal feelings (worst depressed)
Measured: 30 mins
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2018
- Study start21 Dec 2017
- Primary completion4 Apr 2018
- Study completion4 Apr 2018
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03471429
- Sponsor's protocol ID
- CANINE
- Acronym
- CANINE
- Status last verified
- Feb 2018
- First submitted
- 20 Feb 2018
- Last updated
- 21 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kline JA, Fisher MA, Pettit KL, Linville CT, Beck AM. Controlled clinical trial of canine therapy versus usual care to reduce patient anxiety in the emergency department. PLoS One. 2019 Jan 9;14(1):e0209232. doi: 10.1371/journal.pone.0209232. eCollection 2019.
PubMed 30625184
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Canine-assisted ANxiety Reduction IN Emergency
- ClinicalTrials.gov ID
- NCT03471429
- Acronym / sponsor ID
- CANINE / CANINE
- Conditions
- Anxiety
- Keywords
- Anxiety, Dog, Canine, Therapy, Depression, Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 21 Dec 2017 (actual)
- Primary completion
- 4 Apr 2018 (actual)
- Study completion
- 4 Apr 2018 (actual)
- First posted
- 20 Mar 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.
The purpose of this study is to see if dogs can reduce the anxiety level of patients in the emergency department.
Detailed description
Patients will score their pain, anxiety, and depression. A dog will then come into the patient's room for approximately 15 minutes after which the patient will score his/her pain, anxiety, and depression again.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dog | – | –Patient sees therapy dog for 15 minutes, which is standard of care at this hospital. |
| No Dog | – | –Patient receives standard of care |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients enrolled from Emergency Department that are 18 or older with moderate or greater anxiety, per physician Gestalt.
Key inclusion criteria (1 listed)
- Research staff will screen for inclusion criterion by asking the care providers if they agree with this statement, "I believe this patient is experiencing moderate or greater anxiety".
Key exclusion criteria (1 listed)
- Extreme intoxication, agitation that precludes conversation with the patient, fear of dogs, dog bite, allergy to dogs.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Anxiety reduction from Scale
Time frame: 30 mins
reduction in anxiety score (0-10). 0=balanced mood (least anxiety) 2= slight fear and worry 4=mild fear and worry 6= moderate worry, physical agitation 8=Feeling really bad, at the edge 10=out of control behavior, self-harm (worst anxiety)
2 secondary outcomes
Pain reduction from Wong Baker faces scale
Time frame: 30 mins
Depression reduction from scale
Time frame: 30 mins
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 21 Sep 2018.
- Derived from this study: PubMed 30625184Kline JA, Fisher MA, Pettit KL, Linville CT, Beck AM. Controlled clinical trial of canine therapy versus usual care to reduce patient anxiety in the emergency department. PLoS One. 2019 Jan 9;14(1):e0209232. doi: 10.1371/journal.pone.0209232. eCollection 2019.
- Individual participant dataSharing planned: No
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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?
An observational study of Anxiety, 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 1 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 21 Sep 2018. 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. 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?
Anxiety reduction from Scale (time frame: 30 mins). 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 NCT03471429, 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 21 Sep 2018.