Animal-Assisted Interactions in Children With Life-Threatening Conditions and Their Parents
Purpose
This study will evaluate the effects of animal-assisted interactions (AAI) on stress, anxiety, and quality of life in children with a life-threatening condition and their parents. It is anticipated to be a milestone in understanding the human-animal bond.
Conditions
- Advanced Cancer
- Relapsed Cancer
- Refractory Cancer
Eligibility
- Eligible Ages
- Between 3 Years and 17 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Children 3-17 years old - Confirmed diagnosis of relapsed or refractory cancer
Exclusion Criteria
- Reported fear or anxiety of dogs (child or parent)
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Supportive Care
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Animal-Assisted Interactions |
Children and their caregivers randomly assigned to the intervention group will spend approximately 15 min with a registered canine and its owner during potentially anxiety-producing visits to the hospital. |
|
|
Active Comparator Usual Care |
Children and their caregivers randomly assigned to the usual care group will receive usual care which may include play therapy, music therapy or visits with a social worker during their visits to the hospital. |
|
More Details
- Status
- Completed
- Sponsor
- Vanderbilt-Ingram Cancer Center
Study Contact
Detailed Description
Objectives: 1. Examine the feasibility of animal-assisted interactions sessions for children with a life-threatening condition and primary caregiver to: - Identify and document modifications for a safe and feasible intervention, - Obtain recruitment estimates and determine potential recruitment barriers - Evaluate elements of implementation fidelity (design, training, delivery/receipt of Treatment, enactment) - Verify safety. H1-1: Children and parents (>60%) will complete the interventions and provide positive acceptability data. H1-2: Implementation fidelity can be achieved with the proposed methodology 2. Determine the preliminary efficacy of animal-assisted interactions sessions for: - Children with a life-threatening condition (LTC) for the outcome of health-related quality of life - Children with a LTC and their primary caregivers for the outcomes of stress and anxiety H2-1 Children with a life-threatening condition who receive animal-assisted interactions will experience improved health-related quality of life (HRQOL) more than patients who do not receive animal-assisted interactions. H2-2a Children with life-threatening condition who receive animal-assisted interactions will experience decreased stress and anxiety more than parents of children who do not receive animal-assisted interactions. H2-2b Primary caregivers of children with a life-threatening condition who receive animal-assisted interactions will experience decreased stress and anxiety more than parents of children who do not receive animal-assisted interactions.