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Completed

NCT Number: NCT03765099

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

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.

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Key information

Conditions

Advanced Cancer Disease Attributes Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence Refractory Cancer Relapsed Cancer

Age range

3 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Monroe Carell Jr Children's Hospital at Vanderbilt

Nashville, Tennessee, 37232, United States

About this study

Objectives:

  • 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

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Other names: AAI

Primary outcomes

  1. Pediatric Quality of Life

    Time frame: up to 3 months

    The Peds Quality of Life measure will be administered to children and their parents (proxy) once a month

  2. Anxiety

    Time frame: up to 3 months

    The state-trait anxiety inventory will be administered to children and their parents after each intervention or usual care visit

  3. Stress

    Time frame: up to 3 months

    Saliva samples to measure cortisol levels will be administered to children after animal-assisted interventions or after completion of measures in usual care group

Sponsors and collaborators

Lead sponsor

Vanderbilt-Ingram Cancer Center

Other

Collaborators

  • Human Animal Bond Research Institute

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Dec 5, 2018
Registry last updated
Jan 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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