NCT03471429

Brief Summary

The purpose of this study is to see if dogs can reduce the anxiety level of patients in the emergency department.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 21, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 20, 2018

Completed
28 days until next milestone

First Posted

Study publicly available on registry

March 20, 2018

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 4, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 4, 2018

Completed
Last Updated

September 21, 2018

Status Verified

February 1, 2018

Enrollment Period

3 months

First QC Date

February 20, 2018

Last Update Submit

September 20, 2018

Conditions

Anxiety

Keywords

AnxietyDogCanineTherapyDepressionPain

Outcome Measures

Primary Outcomes (1)

  • 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)

    30 mins

Secondary Outcomes (2)

  • Pain reduction from Wong Baker faces scale

    30 mins

  • Depression reduction from scale

    30 mins

Study Arms (2)

Dog

Patient sees therapy dog for 15 minutes, which is standard of care at this hospital.

No Dog

Patient receives standard of care

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients enrolled from Emergency Department that are 18 or older with moderate or greater anxiety, per physician Gestalt.

You may not qualify if:

  • Extreme intoxication, agitation that precludes conversation with the patient, fear of dogs, dog bite, allergy to dogs.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Indiana University

Indianapolis, Indiana, 46202, United States

Location

Related Publications (1)

  • 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.

    PMID: 30625184DERIVED

MeSH Terms

Conditions

Anxiety DisordersDepressionPain

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehaviorNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2018

First Posted

March 20, 2018

Study Start

December 21, 2017

Primary Completion

April 4, 2018

Study Completion

April 4, 2018

Last Updated

September 21, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)