Feasability of Foot Reflexology to Alleviate Anxiety in Palliative Care Unit : a Pilot Randomised Double Blind Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- feasibility of foot reflexology in palliative care unit
研究概览
简要总结
The primary purpose of the study is to know if foot reflexology can be accepted by patients hospitalized in palliative unit care (assessed by the number of patient who accept to participate), and if it is feasible (assessed by the realization of one session in normal condition : duration of 15-20 min, in supine position/seated or half-seated position).The investigators make the hypothesis that patients will accept to receive foot reflexology, and maybe feel less anxious after one session.
详细描述
The patients will receive an informative content about the study and will have 24 hours of reflexion. If they accept to participate to the study, they will be randomised in one of the two groups : foot reflexology or "toucher massage" (for those randomised in the "toucher massage" group, a session of foot reflexology will be proposed in a second time). The investigators will assess the level of anxiety, the quality of the sleep and the pain using the ESAS scale, before and after the session. 24 hours after the session, they will be interviewed about what they felt with the session. The investigators will also have a look on the anxiolytic and antagic medication they consume before and after the session.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult able to give consent, man or woman, hospitalized in palliative care unit, with vigilance criteria from +1 to -3 on the Richmond scale.
- •Affiliated to Social Security
排除标准
- •Painfull bone metastasis on the feet
- •foot amputation
- •foot bedsore
- •peripheral distal neuropathy, trouble of foot sensibility
- •agonic or pre agonic state
- •Patients under juridical protection
- •Refusal to participate to the study
研究组 & 干预措施
foot reflexology
patients will receive one session of foot reflexology with a nurse who received a specific formation. The session lasts 15 to 20 minutes, patients seated, half seated or in supine position. The technique consists in stimulating reflex zones of foot, each zone corresponding to a specific organ. Almond oil will be used. The session is accompanied by relaxing music
干预措施: foot reflexology (Other)
toucher massage
patients will receive one session of toucher massage with a nurse (this technique is taught during the formation of every nurse in palliative care units). The session lasts 15 to 20 minutes, patients seated, half seated or in supine position. It consists in a simple massage and effleurage, with fluid and progressive movements. Almond oil will be used. The session is accompanied by relaxing music.
干预措施: toucher massage (Other)
结局指标
主要结局
feasibility of foot reflexology in palliative care unit
时间窗: day 0
The feasibility will be assessed by the conditions of realization of one session : for the study, the normal conditions will be : duration (15-20 min) and possibility for the patient to remain in the good position (supine position/seated or half-seated position).
acceptability of foot reflexology in palliative care unit
时间窗: day 0
the acceptability will be assessed by the number of patient who accept to participate to the study
次要结局
- Effects of foot reflexology on sleep quality(Before the session (day 0) and 24 hours after)
- Effects of foot reflexology on anxiety(Before the session (day 0) and 24 hours after)
- Effects of foot reflexology on anxiolytic intake(Before the session (day 0) and 24 hours after)
- Effects of foot reflexology on pain killers intake(Before the session (day 0) and 24 hours after)
- patients' experience(day 1)
- Effects of foot reflexology on pain(Before the session (day 0) and 24 hours after)