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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03765099
Other study ID # VICC PED 18166
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 21, 2019
Est. completion date December 31, 2022

Study information

Verified date January 2023
Source Vanderbilt-Ingram Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 70
Est. completion date December 31, 2022
Est. primary completion date December 31, 2021
Accepts healthy volunteers No
Gender All
Age group 3 Years to 17 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States Monroe Carell Jr Children's Hospital at Vanderbilt Nashville Tennessee

Sponsors (2)

Lead Sponsor Collaborator
Vanderbilt-Ingram Cancer Center Human Animal Bond Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pediatric Quality of Life The Peds Quality of Life measure will be administered to children and their parents (proxy) once a month up to 3 months
Primary Anxiety The state-trait anxiety inventory will be administered to children and their parents after each intervention or usual care visit up to 3 months
Primary 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 up to 3 months
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