Effectiveness of Relational Touch in the Management of Chronic Pain in Institutionalized Elderly
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 2
- 主要终点
- SCALE DOLOPLUS BEHAVIORAL ASSESSMENT OF PAIN IN THE ELDERLY (DOLOPLUS pain score variations)
研究概览
简要总结
The aim is to investigate the feasibility and efficacy of a relational touch / relational intervention on persistent pain in a long term geriatric hospital care ward population. The main issue is the pain reduction. The hypothesis is that this type of intervention is very useful on pain reduction in old people even with physical or mental disability.
详细描述
The first 74 patients wanting to participate are randomly assigned to 2 groups: relational- touch or relational. Inclusion criteria are : patients with chronic pain; age >65y and informed consent. Where patients had mental impairment the family's agreement is solicited. The regional Ethics Committee agreement was granted. The intervention consists of 6 Relational versus Relational- Touch sessions (twice a week) .Evaluation takes place after the second, 4th and 6th sessions and in the 4th week following the intervention. The main outcome is the pain reduction.
The primary outcome measure is the pain reduction according to the DOLOPLUS scale and the VRS; the secondary outcomes measures are : patient's participation rate; pain related symptoms variation; overall benefit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >65 y
- •Chronic pain > 3 months
- •Follow up 4 weeks
- •Patient's speak french
- •Patient's or representative's agreement to participate and to the informatics treatment of the data
排除标准
- •acute pain
- •unstable clinical status
结局指标
主要结局
SCALE DOLOPLUS BEHAVIORAL ASSESSMENT OF PAIN IN THE ELDERLY (DOLOPLUS pain score variations)
时间窗: change from baseline to 4th week
Pain assessment : DOLOPLUS pain score variations at baseline and in the 4th week following the intervention (for all patients)
次要结局
- Scale of Guy (Pain related symptoms)(at 3th week and 4th week)
- Acceptability rate at each session(2 sessions per week for 3 weeks and in 4 th week)
- Global benefit questionary(2 sessions per week for 4 weeks and one after the 6 sessions)
- score variations of Verbal Rating Scale (VRS)(change from baseline to 4th week)
- Global benefit questionary (nurse, doctor, carer)(after the 6 sessions)