Impact of Facility Dog Intervention on Pediatric Patients

NCT07221006 | Not Yet Recruiting

• 1 other identifier: 25-1381
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Inpatients; Pediatric

Keywords

Emotional Support Dog; Pet Therapy Dog; Child Life Specialist; anxiety; fear

Outcome Measures

Primary Outcomes (3)

• Spielberger State Trait Anxiety Inventory Short Form

  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.

  Baseline and approximately 15 minutes after starting the intervention.

• Children's Fear Scale

  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.

  Baseline and approximately 15 minutes after starting the intervention.

• Coping Questionnaire - Child

  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.

  Approximately 15 minutes after starting the intervention.

Secondary Outcomes (2)

• Heart Rate

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

• Parent Survey

  Before the intervention.

Study Arms (3)

Child life specialist intervention + facility dog led mindfulness

EXPERIMENTAL

Participants will receive a 20-minute mindfulness coping intervention from a CCLS handler and their facility dog. The CCLS will introduce themselves and their facility dog and explain the activity, then implement a guided mindfulness activity while the child holds their hand on the facility dog's stomach/chest.

Behavioral: Mindfulness Activity led by CCLS and Facility Dog

Child life specialist led mindfulness

ACTIVE COMPARATOR

Participants will receive a 20-minute mindfulness coping intervention from a CCLS. The CCLS will introduce themselves and their role and explain the activity and then implement a guided mindfulness activity while the child holds a stress ball.

Behavioral: Mindfulness Activity led by CCLS

Child life activity coordinator led coloring activity

OTHER

Participants will complete a 20-minute coloring activity facilitated by a Child Life Activity Coordinator (CLAC). Children aged 8-12 years old will be provided a medical dog coloring sheet with crayons; children aged 13-17 years old will be provided an adult coloring sheet that uses a dog image and colored pencils.

Behavioral: Coloring page activity led by CLAC

Interventions

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.

Child life activity coordinator led coloring activity

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.

Child life specialist led mindfulness

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.

Child life specialist intervention + facility dog led mindfulness

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children's Hospital Colorado: lead

Study Sites (1)

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Sarah Scott

  Children's Hospital Colorado

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Claire Simonsen, BA

CONTACT

720-777-5313; claire.simonsen@childrenscolorado.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 23, 2025
• First Posted: October 27, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 3, 2025

Record last verified: 2025-10

Locations

US (1)