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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04942678
Other study ID # 21.0190
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 25, 2021
Est. completion date July 26, 2021

Study information

Verified date March 2022
Source University of Louisville
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 41
Est. completion date July 26, 2021
Est. primary completion date July 26, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 4 Years to 12 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
10-minute visit with therapy dog and child life specialist 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.

Locations

Country Name City State
United States Norton Children's Hospital Louisville Kentucky

Sponsors (1)

Lead Sponsor Collaborator
University of Louisville

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in observed anxiety score as measured by Child Emotional Manifestation Scale (CEMS) before and after therapy dog visit 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 Change in perceived anxiety level of patient by parent as measured by Subjective Units of Distress Scale (SUDs) before and after therapy Dog Visit 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
Secondary Overall Parent Satisfaction Parents will complete a survey describing their satisfaction with their visit Immediately after completion of intervention
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