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NCT Number: NCT07221006

Impact of Facility Dog Intervention on Pediatric Patients

The goal of this clinical trial is to learn if medical dog intervention facilitated by a Certified Child Life Specialist (CCLS) impacts pediatric patient coping, fear, and anxiety during inpatient admissions. The main questions it aims to answer are:

What impact does facility dog support via a CCLS have on patient fear, coping, and anxiety? What effect does facility dog support via a CCLS have on patient heart rate? Researchers will compare medical dog intervention facilitated by a CCLS, CCLS intervention, and a coloring activity to see if medical dog interventions positively impact coping, fear, and anxiety.

Participants will:

Receive a visit from a medical dog and their CCLS handler, a CCLS, or a Child Life Activity coordinator.

Engage in a mindfulness or coloring activity. Answer surveys regarding anxiety, coping, and fear. Have their heart rate measured before, during, and after their assigned intervention.

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Key information

Age range

8 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Children admitted to an inpatient unit at Children's Hospital Colorado Anschutz Medical Campus
  • Who are eight to 17 years old.

Exclusion criteria

  • Isolation precautions
  • Primary reason for admission is due to suicidality, self-injurious behavior, or injurious behavior
  • Patients with history of or currently presenting with aggression or unsafe behavior
  • Severe comorbidities secondary to traumatic brain injury, neurological disorder or neurodevelopmental issues that may confound study outcomes and administration of the study protocol (e.g., intellectual disability)
  • Not medically stable
  • Have a fear of dogs
  • Have an allergy to dogs
  • Have had a visit from a medical dog and medical dog handler during their current admission
  • Patient has an urgent or time-sensitive need requiring medical dog support - Patient is non-verbal.

Treatment and study plan

Coloring page activity led by CLAC

Behavioral

Participants will be provided coloring pages and colored pencils or crayons led by a Child Life Activity Coordinator, and will engage in the activity for 15 minutes.

Mindfulness Activity led by CCLS

Behavioral

Participants will engage in a 10 minute mindfulness activity led by a Certified Child Life Specialist who will follow a mindfulness script. Participants will hold a stress ball during the activity.

Mindfulness Activity led by CCLS and Facility Dog

Behavioral

Participants will engage in a 10 minute mindfulness activity led by a Certified Child Life Specialist who will follow a mindfulness script. Participants will be able to be next to and touch the medical dog during the activity.

Primary outcomes

  1. Spielberger State Trait Anxiety Inventory Short Form

    Time frame: Baseline and approximately 15 minutes after starting the intervention.

    A 6-item measure that assesses anxiety via self-report. Individuals rate their agreement with six statements on a 4-point scale, ranging from 1 (not at all) to 4 (very much), with higher scores indicating more anxiety.

  2. Children's Fear Scale

    Time frame: Baseline and approximately 15 minutes after starting the intervention.

    A 1-item measure that assesses fear via self-report faces scale. Individuals rate their fear on a scale, ranging from no fear to extreme fear, by selecting one of five face pictures that matches how they feel.

  3. Coping Questionnaire - Child

    Time frame: Approximately 15 minutes after starting the intervention.

    Measures youth's perceived ability to cope on a three-item, individualized measure. Children rate their ability to make themselves less upset during an anxiety-provoking situation on a 7-point scale, ranging from 1 (not at all able to help myself or him/herself) to 7, with lower scores indicating poor coping.

Secondary outcomes

  1. Heart Rate

    Time frame: Baseline, before the intervention, 5 minutes after intervention start, post-intervention (approximately 15 minutes after intervention start).

    Participants' heart rate will be measured at four time points using a bedside heart rate monitor.

  2. Parent Survey

    Time frame: Before the intervention.

    Legal guardians will be if the participant has any developmental and/or psychological diagnoses, as well as if the patient has a dog at home.

Study contacts

Contact information is provided by the study sponsor or research team.

Claire Simonsen, BA

CONTACT

[email protected]

720-777-5313

Sponsors and collaborators

Lead sponsor

Children's Hospital Colorado

Other

Registry information

Official study title

Investigating the Impact of Facility Dog Intervention on Pediatric Patient Fear, Coping, and Anxiety During Inpatient Admission

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 27, 2025
Registry last updated
Nov 3, 2025

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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