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OpenTrials
Completed

NCT Number: NCT04942678

The Impact of Therapy Dogs on Anxiety and Emotional Management in the Pediatric Emergency Department

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.

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Key information

Age range

4 year–12 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Norton Children's Hospital

Louisville, Kentucky, 40202, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

10-minute visit with therapy dog and child life specialist handler

Behavioral

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. Overall Parent Satisfaction

    Time frame: Immediately after completion of intervention

    Parents will complete a survey describing their satisfaction with their visit

Sponsors and collaborators

Lead sponsor

University of Louisville

Other

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jun 28, 2021
Registry last updated
Mar 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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