Trials / Completed
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
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Animal-Assisted Interactions | Child 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.