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Clinical Trial Summary

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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03765099
Study type Interventional
Source Vanderbilt-Ingram Cancer Center
Contact
Status Completed
Phase N/A
Start date February 21, 2019
Completion date December 31, 2022

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