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| Name | Class |
|---|---|
| Human Animal Bond Research Institute | UNKNOWN |
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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.
Objectives:
Examine the feasibility of animal-assisted interactions sessions for children with a life-threatening condition and primary caregiver to:
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maryjo Gilmer, PhD | Vanderbilt Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Monroe Carell Jr Children's Hospital at Vanderbilt | Nashville | Tennessee | 37232 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37751186 | Derived | 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. | |
| 34927159 | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Oct 15, 2020 | Sep 13, 2021 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D012008 | Recurrence |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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