Neurovascular Reactions to Animal-assisted Therapy in Patients With Severe Disorders of Consciousness (DOC): a Randomized-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Near-infrared spectroscopy (NIRS): oxygenated hemoglobin (O2HB), deoxygenated hemoglobin (HHB), total hemoglobin (HB) and blood oxygen saturation (O2Sat)
研究概览
简要总结
There is practical evidence but no scientific investigations that persons with severe disorders of consciousness can profit from animal-assisted therapy regarding their level of awareness.
The aim of this study is to investigate the effect of animal-assisted therapy on brain activity of inpatients at REHAB Basel with severe disorders of consciousness.
To do so, the frontal brain activity of 20 the inpatients at REHAB Basel in a minimally conscious state is investigated via near-infrared spectroscopy (NIRS). Moreover, 20 healthy participants are included as control subjects.
详细描述
Each participant will be measured in 6 sessions. Sessions take place three times a week for 2 weeks (leading up to a total of 3 experimental sessions and 3 control sessions), each lasting for about 15 minutes.
Each session consists of 5 phases, with an animal present in three of them. In the beginning, waiting (with no stimulus presented) serves as baseline measurement. Second, an animal is watched, then the animal is placed on the patient's lap and in the fourth condition, the patient can stroke the animal with the help of the present therapist. After, there is again a waiting condition.
Control sessions are comparable sessions but with a fur pet instead of a live animal as stimulus.
Measurements are: brain activity (near-infrared spectroscopy, NIRS), skin conductance (EDA), heart rate and heart rate variability assessed via photoplethysmography (PPG) during the sessions and the BAVESTA score after each session. For further behavior analysis all sessions are videotaped.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •Enrolment of the investigator, his/her family members, employees and other dependent persons,
- •medical contraindications for contact with animals as allergy, phobia etc.
- •If the patient's medication changes radically during the time of data collection (only eligible for clinical participants)
结局指标
主要结局
Near-infrared spectroscopy (NIRS): oxygenated hemoglobin (O2HB), deoxygenated hemoglobin (HHB), total hemoglobin (HB) and blood oxygen saturation (O2Sat)
时间窗: 2 weeks
All parameters are measured in mmol/ml throughout the sessions, measured via NONIN SenSmart
次要结局
- Galvanic Skin Response(2 weeks)