Anxiety Clinical Trial
Official title:
The Impact of Therapy Dogs on Anxiety and Emotional Management in the Pediatric Emergency Department
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 |
Verified date | March 2022 |
Source | University of Louisville |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Norton Children's Hospital | Louisville | Kentucky |
Lead Sponsor | Collaborator |
---|---|
University of Louisville |
United States,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
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