Impact of Facility Dog Intervention on Pediatric Patients
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8-17
SponsorChildren's Hospital Colorado
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Children admitted to an inpatient unit at Children's Hospital Colorado Anschutz Medical Campus
Who are eight to 17 years old.
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Coloring page activity led by CLAC
BehavioralParticipants 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
BehavioralParticipants 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
BehavioralParticipants 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.
Treatment groups
126 Participants
are divided into 3 treatment groupsGroup A: Child life specialist intervention + facility dog led mindfulnessExperimental treatment 1 intervention
Group B: Child life specialist led mindfulnessActive comparator 1 intervention
Group C: Child life activity coordinator led coloring activityOther 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline and approximately 15 minutes after starting the intervention.2
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.
Time frame
Baseline and approximately 15 minutes after starting the intervention.3
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.
Time frame
Approximately 15 minutes after starting the intervention.Secondary outcomes
1
Heart Rate
Participants' heart rate will be measured at four time points using a bedside heart rate monitor.
Time frame
Baseline, before the intervention, 5 minutes after intervention start, post-intervention (approximately 15 minutes after intervention start).2
Parent Survey
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.
Time frame
Before the intervention.Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: