- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04942678
The Impact of Therapy Dogs on Anxiety and Emotional Management in the Pediatric Emergency Department
March 2, 2022 updated by: Michelle D. Stevenson, University of Louisville
The purpose of this study is to assess the impact of therapy dogs on children's anxiety and emotional management during a visit to the pediatric emergency department.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
41
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Kentucky
-
Louisville, Kentucky, United States, 40202
- Norton Children's Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
4 years to 12 years (CHILD)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients will be recruited at both Norton Children's Hospital Emergency Department and Norton Children's Medical Center Emergency department.
Description
Inclusion Criteria:
- Children with a SUD score of 30 or higher indicated by the caregiver
Exclusion Criteria:
- Active infection: abscesses, fever, respiratory issues, vomiting
- Patients presenting for burn care, dog bite, ESI triage category 1 or 2, or transferred from outside facilities
- Sterile procedures
- Oncology patients / patients with known neutropenia in past medical history
- Parent/caregiver or patient fear of dogs
- Parent/caregiver or patient allergy to dogs
- Dog bite injury
- Already underwent procedure during their visit
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Pediatric patients ages 4-7 years old in the Pediatric Emergency Department
Patients will receive a 10-minute visit with therapy dog and child life handler
|
A visit from a therapy dog and child life specialist will occur which will last for approximately 10 minutes.
Parents and patients will be asked to sanitize their hand prior to the visit.
The child life specialist will be instructed to have ad lib conversation with the family.
The dog will remain on a leash during the visit.
The patient will be free to pet the therapy dog if they wish.
|
|
Pediatric patients ages 8-12 years old in the Pediatric Emergency Department
Patients will receive a 10-minute visit with therapy dog and child life handler
|
A visit from a therapy dog and child life specialist will occur which will last for approximately 10 minutes.
Parents and patients will be asked to sanitize their hand prior to the visit.
The child life specialist will be instructed to have ad lib conversation with the family.
The dog will remain on a leash during the visit.
The patient will be free to pet the therapy dog if they wish.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in observed anxiety score as measured by Child Emotional Manifestation Scale (CEMS) before and after therapy dog visit
Time Frame: change from baseline at 20 minutes after intervention
|
To determine the change in emotional management in children aged 4-12 years after a visit from a therapy dog and child life specialist handler, as measured by an observed CEMS score (Children's Emotional Management Scale) before and after the visit.
This will be completed by an investigator.
Scores range from 5-25, with higher scores indicating higher levels of observed anxiety.
|
change from baseline at 20 minutes after intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in perceived anxiety level of patient by parent as measured by Subjective Units of Distress Scale (SUDs) before and after therapy Dog Visit
Time Frame: change from baseline at 20 minutes after intervention
|
To determine the change in perceived level of child anxiety as reported by parents after a visit with a therapy dog and child life specialist handler.
This will be measured using the Subjective Unit of Distress (SUD) score.
Scores range from 0-100 with higher scores indicating higher levels of perceived anxiety by the parent.
|
change from baseline at 20 minutes after intervention
|
|
Overall Parent Satisfaction
Time Frame: Immediately after completion of intervention
|
Parents will complete a survey describing their satisfaction with their visit
|
Immediately after completion of intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
May 25, 2021
Primary Completion (ACTUAL)
July 26, 2021
Study Completion (ACTUAL)
July 26, 2021
Study Registration Dates
First Submitted
March 25, 2021
First Submitted That Met QC Criteria
June 25, 2021
First Posted (ACTUAL)
June 28, 2021
Study Record Updates
Last Update Posted (ACTUAL)
March 17, 2022
Last Update Submitted That Met QC Criteria
March 2, 2022
Last Verified
March 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 21.0190
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.