NCT03765099

Animal-Assisted Interactions in Children With Life-Threatening Conditions and Their Parents

Effects of Animal-Assisted Interactions (AAI) on Quality of Life in Children With Life-Threatening Conditions and Their Parents

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Vanderbilt-Ingram Cancer Center · Academic / Other
• Sex: All
• Age: 3 Years – 17 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Advanced Cancer
• Relapsed Cancer
• Refractory Cancer

Interventions

Type	Name	Description
BEHAVIORAL	Animal-Assisted Interactions	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.

Timeline

• Start date: 2019-02-21
• Primary completion: 2021-12-31
• Completion: 2022-12-31
• First posted: 2018-12-05
• Last updated: 2023-01-23

Locations

1 site across 1 country: United States