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CompletedNCT04310345

Impact of Human-Animal Interactions on Children With Life-Threatening Conditions and Their Parents

Exploring the Impact of Human-Animal Interactions on Children With Life-Threatening Conditions and Their Parents

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
74 (actual)
Sponsor
Vanderbilt-Ingram Cancer Center · Academic / Other
Sex
All
Age
6 Years
Healthy volunteers
Accepted

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 6-17 years old with a life threatening cancer and their parent caregivers.

Detailed description

Objectives: * To examine the feasibility of human-animal interaction (HAI) sessions for children with a life threatening cancer and a primary caregiver, specifically to: * To identify and document necessary modifications for a safe and feasible intervention * To obtain recruitment estimates and determine potential recruitment barriers * To evaluate elements of implementation fidelity (design, training, delivery/receipt of treatment, enactment) * To verify safety * To determine the preliminary efficacy of human-animal interaction sessions: * On children with a life threatening cancer for the outcomes of qualify of life, anxiety, depression, worry, and pain * 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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALAnimal-Assisted InteractionsChild 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.

Timeline

Start date
2021-03-31
Primary completion
2024-02-09
Completion
2024-06-27
First posted
2020-03-17
Last updated
2024-08-19
Results posted
2024-08-19

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT04310345. Inclusion in this directory is not an endorsement.

Impact of Human-Animal Interactions on Children With Life-Threatening Conditions and Their Parents (NCT04310345) · Clinical Trials Directory