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

NCT03765099 | Completed DMC

• 1 other identifier: VICC PED 18166
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Advanced Cancer; Relapsed Cancer; Refractory Cancer

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (2)

Animal-Assisted Interactions

EXPERIMENTAL

Children and their 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.

Behavioral: Animal-Assisted Interactions

Usual Care

ACTIVE COMPARATOR

Children and their caregivers randomly assigned to the usual care group will receive usual care which may include play therapy, music therapy or visits with a social worker during their visits to the hospital.

Behavioral: Animal-Assisted Interactions

Interventions

Animal-Assisted Interactions BEHAVIORAL

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.

Also known as: AAI

Animal-Assisted Interactions; Usual Care

Eligibility Criteria

• Age: 3 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children 3-17 years old
• Confirmed diagnosis of relapsed or refractory cancer

You may not qualify if:

• Reported fear or anxiety of dogs (child or parent)

Sponsors & Collaborators

• Vanderbilt-Ingram Cancer Center: lead
• Human Animal Bond Research Institute: collaborator

Study Sites (1)

Monroe Carell Jr Children's Hospital at Vanderbilt

Nashville, Tennessee, 37232, United States

Location

Related Publications (2)

• Mahoney AB, Akard TF, Cowfer BA, Dietrich MS, Newton JL, Gilmer MJ. Impact of Animal-Assisted Interaction on Anxiety in Children With Advanced Cancer and Their Caregivers. J Palliat Med. 2024 Jan;27(1):75-82. doi: 10.1089/jpm.2023.0091. Epub 2023 Sep 25.

  PMID: 37751186 DERIVED

• Cowfer BA, Akard TF, Gilmer MJ. Animal-Assisted Interventions for Children with Advanced Cancer: Child and Parent Perceptions. Palliat Med Rep. 2021 Nov 17;2(1):328-334. doi: 10.1089/pmr.2021.0039. eCollection 2021.

  PMID: 34927159 DERIVED

MeSH Terms

Conditions

Recurrence; Neoplasms

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Maryjo Gilmer, PhD

  Vanderbilt Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Sponsor Investigator

Study Record Dates

• First Submitted: December 3, 2018
• First Posted: December 5, 2018
• Study Start: February 21, 2019
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2022
• Last Updated: January 23, 2023

Record last verified: 2023-01

Locations

US (1)