InpatientsNCT07221006
Impact of Facility Dog Intervention on Pediatric Patients
A study testing Coloring page activity led by CLAC, Mindfulness Activity led by CCLS and Mindfulness Activity led by CCLS and Facility Dog in people with Inpatients and Pediatric, run by Children's Hospital Colorado at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 17 years
- Conditions the study is for
- Inpatients, Pediatric
- What is being tested?
- Coloring page activity led by CLAC, Mindfulness Activity led by CCLS and Mindfulness Activity led by CCLS and Facility Dog
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2025to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children admitted to an inpatient unit at Children's Hospital Colorado Anschutz Medical Campus
- Who are eight to 17 years old.
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Children's Hospital Colorado
Aurora, Colorado, 80045
Claire Simonsen, BA, 720-777-5313, claire.simonsen@childrenscolorado.org
About this study
Official title: Investigating the Impact of Facility Dog Intervention on Pediatric Patient Fear, Coping, and Anxiety During Inpatient Admission
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.
Read more
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
- Being tested
- Coloring page activity led by CLAC, Mindfulness Activity led by CCLS, Mindfulness Activity led by CCLS and Facility Dog
- Keywords
- Emotional Support Dog, Pet Therapy Dog, Child Life Specialist, anxiety, fear
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coloring page activity led by CLACBehavioural
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 CCLSBehavioural
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 DogBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: Coloring page activity led by CLAC |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Approximately 15 minutes after starting the intervention.
Secondary outcomes (2)
Heart Rate
Participants' heart rate will be measured at four time points using a bedside heart rate monitor.
Measured: Baseline, before the intervention, 5 minutes after intervention start, post-intervention (approximately 15 minutes after intervention start).
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.
Measured: Before the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2025
- Study start1 Dec 2025 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InpatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Colorado
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarah Scott, Children's Hospital Colorado
- Investigators
- Sarah Scott, Principal investigator, Children's Hospital Colorado
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07221006
- Sponsor's protocol ID
- 25-1381
- Status last verified
- Oct 2025
- First submitted
- 23 Oct 2025
- Last updated
- 3 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Impact of Facility Dog Intervention on Pediatric Patient Fear, Coping, and Anxiety During Inpatient Admission
- ClinicalTrials.gov ID
- NCT07221006
- Acronym / sponsor ID
- 25-1381
- Conditions
- Inpatients, Pediatric
- Keywords
- Emotional Support Dog, Pet Therapy Dog, Child Life Specialist, anxiety, fear
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Children's Hospital ColoradoUniversity, hospital or other
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 27 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Child life specialist intervention + facility dog led mindfulness | Experimental | Behavioral: Mindfulness Activity led by CCLS and Facility DogParticipants 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. |
| Child life specialist led mindfulness | Active comparator | Behavioral: Mindfulness Activity led by CCLSParticipants 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. |
| Child life activity coordinator led coloring activity | Other | Behavioral: Coloring page activity led by CLACParticipants 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. |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children admitted to an inpatient unit at Children's Hospital Colorado Anschutz Medical Campus
- Who are eight to 17 years old.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coloring page activity led by CLACParticipants 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. | Behavioural | Child life activity coordinator led coloring activity |
| Mindfulness Activity led by CCLSParticipants 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. | Behavioural | Child life specialist led mindfulness |
| Mindfulness Activity led by CCLS and Facility DogParticipants 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. | Behavioural | Child life specialist intervention + facility dog led mindfulness |
Primary outcome
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.
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.
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.
2 secondary outcomes
Heart Rate
Time frame: Baseline, before the intervention, 5 minutes after intervention start, post-intervention (approximately 15 minutes after intervention start).
Parent Survey
Time frame: Before the intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sarah Scott principal investigator
Children's Hospital Colorado
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coloring page activity led by CLAC, Mindfulness Activity led by CCLS and Mindfulness Activity led by CCLS and Facility Dog in people with Inpatients and Pediatric, run by Children's Hospital Colorado at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Claire Simonsen, BA (720-777-5313, claire.simonsen@childrenscolorado.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spielberger State Trait Anxiety Inventory Short Form (time frame: Baseline and approximately 15 minutes after starting the intervention.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2025.