Impact of Inclusion of a Dog as Part of the Fibromyalgia Treatment Program on Patient's Physical and Mental Health Functioning - A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 229
- 试验地点
- 4
- 主要终点
- Change in Revised Fibromyalgia Impact Questionnaire (FIQR) score
研究概览
简要总结
In this study the investigators hypothesize that the presence of a Mayo Clinic certified therapy dog will provide additional benefits above typical therapy for patients suffering from fibromyalgia currently enrolled in the Mayo Clinic Fibromyalgia Program.
详细描述
The human animal bond refers an emotional relationship between animals and people. The purpose of this study is to evaluate whether the presence of a dog provide additional benefits above typical therapy for patients suffering from fibromyalgia and also to assess the emotional wellbeing state of the therapy dog.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Dog interaction
Dog interaction will be received by patients in addition to usual care of fibromyalgia.
干预措施: Dog Interaction (Behavioral)
Human Interaction
Human interaction will be received by patients in addition to usual care of fibromyalgia.
干预措施: Human Interaction (Behavioral)
结局指标
主要结局
Change in Revised Fibromyalgia Impact Questionnaire (FIQR) score
时间窗: Baseline to 1.5 day
The FIQR questionnaire consists of 21 questions in 3 domains. Each question has 11 boxes similar to a visual analog scale, rating the item from no difficulty to very difficult. To score the FIQR, the researcher must sum the answers for each domain. Then the function domain is divided by 3, the overall impact domain remains unchanged, and the symptom domain score is divided by 2. The resulting scores are added, and final score can range from 0 -100, with 0=no difficulty, and 100=great difficulty.
次要结局
- Change in Pain Intensity Score (Numeric Rating Scale (NRS))(Baseline to 1.5 day)
- Change in Score for Fatigue, Anxiety, and Depression(Baseline to 1.5 day)