Impact of Human-Animal Interactions on Children With Life-Threatening Conditions and Their Parents
Study Details
Study Description
Brief Summary
This study will evaluate the effects of human-animal interaction on reducing anxiety, depression, worry, and pain and enhancing quality of life in children ages 8-17 years old with a life threatening cancer and their parent caregivers.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Objectives:
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To examine the feasibility of human-animal interaction (HAI) sessions for children with a life threatening cancer and a primary caregiver, specifically to:
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To identify and document necessary modifications for a safe and feasible intervention
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To obtain recruitment estimates and determine potential recruitment barriers
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To evaluate elements of implementation fidelity (design, training, delivery/receipt of treatment, enactment)
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To verify safety
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To determine the preliminary efficacy of human-animal interaction sessions:
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On children with a life threatening cancer for the outcomes of qualify of life, anxiety, depression, worry, and pain
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On caregivers of children with a life threatening cancer for the outcomes of stress and anxiety
Exploratory Objective:
- To explore mechanisms (reduced salivary cortisol and urinary norepinephrine levels) associated with 8 weeks of human-animal interaction.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Animal-Assisted Interaction Children and their caregivers will spend approximately 10-15 minutes with a registered canine and its owner during potentially anxiety-producing visits to the clinic or hospital. |
Behavioral: Animal-Assisted Interactions
Child and caregivers will spend approximately 10-5 minutes with a registered canine and its owner during potentially anxiety-producing visits to the clinic or hospital.
|
Outcome Measures
Primary Outcome Measures
- Pediatric Quality of Life [Up to 2 months]
The Peds Quality of Life measure will be administered to children and their parents (proxy) at baseline and once a month
- Anxiety [Up to 2 months]
The state-trait anxiety inventory will be administered to children and their parents at baseline and once a month
Eligibility Criteria
Criteria
Inclusion Criteria:
Child:
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Children age 8-17 years old that have been diagnosed with advanced cancer as defined by any stage of relapsed, recurrent or refractory cancer
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Able to understand English or Spanish to complete consents and surveys
Parent or Guardian:
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Parent or guardian as determined by person who brings child to >50% of their clinic visits
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Able to understand English or Spanish to complete consents and surveys
Exclusion Criteria for both Children and Parent/Guardian:
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Self-reported fear of or allergies to canines
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Cognitive impairment as identified by healthcare team or inability to complete consenting process
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Monroe Carell Jr Children's Hospital at Vanderbilt | Nashville | Tennessee | United States | 37232 |
Sponsors and Collaborators
- Vanderbilt-Ingram Cancer Center
- National Institutes of Health (NIH)
Investigators
- Principal Investigator: Maryjo Gilmer, PhD, Vanderbilt Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- VICC PED 2003