Effects of Animal-Assisted Interactions (AAI) on Quality of Life in Children With Life-Threatening Conditions and Their Parents
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Pediatric Quality of Life
研究概览
简要总结
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.
详细描述
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 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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children 3-17 years old
- •Confirmed diagnosis of relapsed or refractory cancer
排除标准
- •Reported fear or anxiety of dogs (child or parent)
研究组 & 干预措施
Animal-Assisted Interactions
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.
干预措施: Animal-Assisted Interactions (Behavioral)
Usual Care
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.
干预措施: Animal-Assisted Interactions (Behavioral)
结局指标
主要结局
Pediatric Quality of Life
时间窗: up to 3 months
The Peds Quality of Life measure will be administered to children and their parents (proxy) once a month
Anxiety
时间窗: up to 3 months
The state-trait anxiety inventory will be administered to children and their parents after each intervention or usual care visit
Stress
时间窗: 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
次要结局
未报告次要终点
研究者
Maryjo Gilmer
Sponsor Investigator
Vanderbilt-Ingram Cancer Center