Anxiety AcuteCANINE IVNCT04287452
Canine-Assisted ANxiety Reduction IN Emergency Care IV
A study testing Dog Therapy in people with Anxiety Acute and Chronic Pain, run by Indiana University at 1 site in United States.
Trial summary
Prior literature demonstrates that human stress can be reduced with exposure to animals. This study challenges current dogma by introducing a widely available, low cost method of dog therapy to reduce patient and provider stress. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety Acute, Chronic Pain
- What is being tested?
- Dog Therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2022to 31 Dec 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients
- Age 18-89 years
- Chronic pain, defined as pain on most days for >6 weeks
- Triage pain score >6 out of 10
- OR
- Age 18-89 years
Show all 12Show fewer
- Currently experience crisis, including suicidality, or
- Meet the standard of a provider assessment of "severe stress" defined by their identification that the patient meets a score of greater than six on the FACES stress scale
- Providers
- Faculty, residents, advanced practitioners, and nurses who work in the ED and identify themselves as being the nurse or physician of record for the enrolled patients.
- Therapy Dog Handlers
- Handler of a certified therapy dog and volunteer of Eskenazi's Therapy Dog Program
Who cannot join
- Patients
- Violent behavior
- Overt intoxication
- Non-English speaking
- Any reported prior fear or adverse reaction to dogs
- Providers
Show all 9Show fewer
- Any reported prior fear or adverse reaction to dogs
- Therapy Dog Handlers
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Canine-Assisted ANxiety Reduction IN Emergency Care IV (CANINE IV)
Prior literature demonstrates that human stress can be reduced with exposure to animals. This study challenges current dogma by introducing a widely available, low cost method of dog therapy to reduce patient and provider stress. The objectives of this study are to determine if interaction with a certified therapy dog and handler can;
- decrease reported anxiety levels in emergency department (ED) patients,
- decrease salivary cortisol in ED patients,
- decrease total morphine equivalent dosing in the emergency department or at discharge and/or,
- decrease reported stress levels in emergency department providers caring for participating patients when compared to usual care.
- Conditions
- Anxiety Acute, Chronic Pain
- Being tested
- Control, Dog 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.
ControlOther
Control
Dog TherapyOther
Exposure to certified therapy dogs and their handler.
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Emergency department patients enrolled in the control arm will receive usual care. Emergency department providers enrolled in the control arm will work their shift as usual. Receives: Other: Control |
| Intervention | Active comparator | Emergency department patients and providers in the intervention arm will be exposed to and/or interact with a certified therapy dog and handler Receives: Other: Dog Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morphine equivalent narcotic administration in emergency department patients with chronic pain
Total morphine equivalent narcotic administration while in the emergency department or as a discharge prescription will be recorded for enrolled patients.
Measured: Date of enrollment until emergency department discharge, up to 72 hours
Change in reported stress levels in ED patients with chronic pain using Wong-Baker FACES Scale (10 = worst)
Change in self reported stress levels of emergency department patients using a Wong-Baker FACES Scale for anxiety between baseline and T1
Measured: Baseline and T1 (~45 minutes after baseline)
Change in salivary cortisol in ED patients with chronic pain
Change in salivary cortisol levels in emergency department patients between baseline and T1
Measured: Baseline and T1 (~45 minutes after baseline)
Number of narcotic, sedative and/or neuroleptic doses administered in ED patients with emotional crisis
Number of narcotic, sedative and/or neuroleptic doses administered in ED patients with emotional crisis
Measured: Date of enrollment until emergency department discharge, up to 72 hours
Change in reported stress levels in ED patients with emotional crisis using Wong-Baker FACES Scale (10 = worst)
Change in self reported stress levels of emergency department patients using a Wong-Baker FACES Scale for anxiety between baseline and T1
Measured: Baseline and T1 (~45 minutes after baseline)
Change in salivary cortisol in ED patients with emotional crisis
Change in salivary cortisol levels in emergency department patients between baseline and T1
Measured: Baseline and T1 (~45 minutes after baseline)
Secondary outcomes (1)
Change in salivary cortisol levels in emergency department patients
Change in salivary cortisol levels in emergency department patients between baseline and T1
Measured: Baseline and T1 (~45 minutes after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2020
- Study start1 Mar 2022 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Why it stopped: The study has been withdrawn due to the pandemic and lack of funding.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Anxiety AcuteStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Healthcare Initiatives, Inc.
- Responsible party
- Principal investigator, Nicholas Pettit, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04287452
- Sponsor's protocol ID
- 001968358
- Acronym
- CANINE IV
- Status last verified
- Jul 2023
- First submitted
- 12 Feb 2020
- Last updated
- 20 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Braun C, Stangler T, Narveson J, Pettingell S. Animal-assisted therapy as a pain relief intervention for children. Complement Ther Clin Pract. 2009 May;15(2):105-9. doi: 10.1016/j.ctcp.2009.02.008. Epub 2009 Mar 3.
PubMed 19341990Marcus DA, Bernstein CD, Constantin JM, Kunkel FA, Breuer P, Hanlon RB. Impact of animal-assisted therapy for outpatients with fibromyalgia. Pain Med. 2013 Jan;14(1):43-51. doi: 10.1111/j.1526-4637.2012.01522.x. Epub 2012 Nov 21.
PubMed 23170993Barker SB, Dawson KS. The effects of animal-assisted therapy on anxiety ratings of hospitalized psychiatric patients. Psychiatr Serv. 1998 Jun;49(6):797-801. doi: 10.1176/ps.49.6.797.
PubMed 9634160Munoz Lasa S, Maximo Bocanegra N, Valero Alcaide R, Atin Arratibel MA, Varela Donoso E, Ferriero G. Animal assisted interventions in neurorehabilitation: a review of the most recent literature. Neurologia. 2015 Jan-Feb;30(1):1-7. doi: 10.1016/j.nrl.2013.01.012. Epub 2013 May 1. English, Spanish.
PubMed 23642347Havey J, Vlasses F, Vlasses P, Ludwig P, Hackbarth D. The Effect of Animal-Assisted Therapy on Pain Medication Use After Joint Replacement. Anthrozoos 2014; 27: 361-369.
Smith DD, Kellar J, Walters EL, Reibling ET, Phan T, Green SM. Does emergency physician empathy reduce thoughts of litigation? A randomised trial. Emerg Med J. 2016 Aug;33(8):548-52. doi: 10.1136/emermed-2015-205312. Epub 2016 Mar 21.
PubMed 27002161Kelm Z, Womer J, Walter JK, Feudtner C. Interventions to cultivate physician empathy: a systematic review. BMC Med Educ. 2014 Oct 14;14:219. doi: 10.1186/1472-6920-14-219.
PubMed 25315848
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Canine-Assisted ANxiety Reduction IN Emergency Care IV (CANINE IV)
- ClinicalTrials.gov ID
- NCT04287452
- Acronym / sponsor ID
- CANINE IV / 001968358
- Conditions
- Anxiety Acute, Chronic Pain
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study has been withdrawn due to the pandemic and lack of funding.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Healthcare Initiatives, Inc.
- Study start
- 1 Mar 2022 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 27 Feb 2020 (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.
Prior literature demonstrates that human stress can be reduced with exposure to animals. This study challenges current dogma by introducing a widely available, low cost method of dog therapy to reduce patient and provider stress. The objectives of this study are to determine if interaction with a certified therapy dog and handler can;
- decrease reported anxiety levels in emergency department (ED) patients,
- decrease salivary cortisol in ED patients,
- decrease total morphine equivalent dosing in the emergency department or at discharge and/or,
- decrease reported stress levels in emergency department providers caring for participating patients when compared to usual care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Other: ControlEmergency department patients enrolled in the control arm will receive usual care. Emergency department providers enrolled in the control arm will work their shift as usual. |
| Intervention | Active comparator | Other: Dog TherapyEmergency department patients and providers in the intervention arm will be exposed to and/or interact with a certified therapy dog and handler |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patients
- Age 18-89 years
- Chronic pain, defined as pain on most days for >6 weeks
- Triage pain score >6 out of 10
- OR
Key exclusion criteria (9 listed)
- Patients
- Violent behavior
- Overt intoxication
- Non-English speaking
- Any reported prior fear or adverse reaction 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ControlControl | Other | Control |
| Dog TherapyExposure to certified therapy dogs and their handler. | Other | Intervention |
Primary outcome
Morphine equivalent narcotic administration in emergency department patients with chronic pain
Time frame: Date of enrollment until emergency department discharge, up to 72 hours
Total morphine equivalent narcotic administration while in the emergency department or as a discharge prescription will be recorded for enrolled patients.
Change in reported stress levels in ED patients with chronic pain using Wong-Baker FACES Scale (10 = worst)
Time frame: Baseline and T1 (~45 minutes after baseline)
Change in self reported stress levels of emergency department patients using a Wong-Baker FACES Scale for anxiety between baseline and T1
Change in salivary cortisol in ED patients with chronic pain
Time frame: Baseline and T1 (~45 minutes after baseline)
Change in salivary cortisol levels in emergency department patients between baseline and T1
Number of narcotic, sedative and/or neuroleptic doses administered in ED patients with emotional crisis
Time frame: Date of enrollment until emergency department discharge, up to 72 hours
Number of narcotic, sedative and/or neuroleptic doses administered in ED patients with emotional crisis
Change in reported stress levels in ED patients with emotional crisis using Wong-Baker FACES Scale (10 = worst)
Time frame: Baseline and T1 (~45 minutes after baseline)
Change in self reported stress levels of emergency department patients using a Wong-Baker FACES Scale for anxiety between baseline and T1
Change in salivary cortisol in ED patients with emotional crisis
Time frame: Baseline and T1 (~45 minutes after baseline)
Change in salivary cortisol levels in emergency department patients between baseline and T1
1 secondary outcome
Change in salivary cortisol levels in emergency department patients
Time frame: Baseline and T1 (~45 minutes after baseline)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2023.
- Background: PubMed 19341990Braun C, Stangler T, Narveson J, Pettingell S. Animal-assisted therapy as a pain relief intervention for children. Complement Ther Clin Pract. 2009 May;15(2):105-9. doi: 10.1016/j.ctcp.2009.02.008. Epub 2009 Mar 3.
- Background: PubMed 23170993Marcus DA, Bernstein CD, Constantin JM, Kunkel FA, Breuer P, Hanlon RB. Impact of animal-assisted therapy for outpatients with fibromyalgia. Pain Med. 2013 Jan;14(1):43-51. doi: 10.1111/j.1526-4637.2012.01522.x. Epub 2012 Nov 21.
- Background: PubMed 9634160Barker SB, Dawson KS. The effects of animal-assisted therapy on anxiety ratings of hospitalized psychiatric patients. Psychiatr Serv. 1998 Jun;49(6):797-801. doi: 10.1176/ps.49.6.797.
- Background: PubMed 23642347Munoz Lasa S, Maximo Bocanegra N, Valero Alcaide R, Atin Arratibel MA, Varela Donoso E, Ferriero G. Animal assisted interventions in neurorehabilitation: a review of the most recent literature. Neurologia. 2015 Jan-Feb;30(1):1-7. doi: 10.1016/j.nrl.2013.01.012. Epub 2013 May 1. English, Spanish.
- BackgroundHavey J, Vlasses F, Vlasses P, Ludwig P, Hackbarth D. The Effect of Animal-Assisted Therapy on Pain Medication Use After Joint Replacement. Anthrozoos 2014; 27: 361-369.
- Background: PubMed 27002161Smith DD, Kellar J, Walters EL, Reibling ET, Phan T, Green SM. Does emergency physician empathy reduce thoughts of litigation? A randomised trial. Emerg Med J. 2016 Aug;33(8):548-52. doi: 10.1136/emermed-2015-205312. Epub 2016 Mar 21.
- Background: PubMed 25315848Kelm Z, Womer J, Walter JK, Feudtner C. Interventions to cultivate physician empathy: a systematic review. BMC Med Educ. 2014 Oct 14;14:219. doi: 10.1186/1472-6920-14-219.
- 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?
A study testing Dog Therapy in people with Anxiety Acute and Chronic Pain, 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 12 inclusion and 9 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: withdrawn, as of the sponsor's last update on 20 Jul 2023. 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 was withdrawn before enrolling participants, so there are no results.
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?
Morphine equivalent narcotic administration in emergency department patients with chronic pain (time frame: Date of enrollment until emergency department discharge, up to 72 hours). The study lists 6 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 NCT04287452, which also lists 7 linked publications.
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 20 Jul 2023.