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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
70
Child and 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.
Monroe Carell Jr Children's Hospital at Vanderbilt
Nashville, Tennessee, United States
Pediatric Quality of Life
The Peds Quality of Life measure will be administered to children and their parents (proxy) once a month
Time frame: up to 3 months
Anxiety
The state-trait anxiety inventory will be administered to children and their parents after each intervention or usual care visit
Time frame: up to 3 months
Stress
Saliva samples to measure cortisol levels will be administered to children after animal-assisted interventions or after completion of measures in usual care group
Time frame: up to 3 months
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