In What Way do Music-based Caregiving Influence Pain, Daily Activity, QOL, Neuropsychiatric Symptoms, and Medication in Patients With Dementia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 276
- 试验地点
- 2
- 主要终点
- Pain Occurence
研究概览
简要总结
The main objective of this study is to evaluate the pain-relieving effect of a well-characterized non-pharmacological treatment program, music-based caregiving (MBC), to patients in nursing homes with dementia and pain. Patients with dementia disease will be recruited from nursing homes in Trondheim and Oslo, and each ward at the nursing homes will be cluster randomized into intervention - or control wards. Then the health care personnel in the intervention wards will receive education in MBC and perform the intervention during eight weeks. The hypothesis is that this non-pharmacological intervention will reduce pain intensity and improve general activity, as well as reduce other symptoms in nursing home patients with dementia and pain compared to baseline.
详细描述
This is a cluster-randomized controlled trial including patients with dementia and pain living at different wards at eight nursing homes.
- About 12 nursing homes are selected to participate in Trondheim and in Oslo.
- All patients at the included nursing homes will be screened with respect to dementia and pain (see screening tools later). If patients have dementia and report pain (≥3 on MOBID 2) they will be included in the intervention part of the study (n=240).
- The included patients will then have a clinical examination of pain and pain management by expert physicians (see below). Evaluation of the use of analgesics and psychopharmacological medication will be performed. Inappropriate medication (both too much and too little) will be corrected in collaboration with the nursing home doctor.
- In addition to the clinical examination of pain, the investigators will measure total daily physical activity, ADL, QOL, and neuropsychiatric symptoms on all included patients.
- After the pre-test - a randomization of the wards into intervention wards or control wards will be performed.
- About five staff members at each of the wards randomized to the intervention group will receive education in the MBC before intervention.
- A post-test just after the intervention has ended, pain, total daily physical activity, ADL, QOL, and neuropsychiatric symptoms will be measured.
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
- Single (Outcomes Assessor)
盲法说明
The included statistician will do the first evaluation of the results
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients living in one of the included nursing homes in Oslo or Trondheim will be included in the first descriptive phase
- •Patients will be included in the intervention part if they report moderate pain or more (≥3 on MOBID) and mild dementia or more (≥1 on CDR).
排除标准
- •They will not be included if they have lived in the nursing home less than four weeks, have short (less than eight weeks) expected lifetime (judged by the nurses),or if they do not understand the Norwegian language.
结局指标
主要结局
Pain Occurence
时间窗: 8 weeks
MOBID 2 observation instrument. The assessment of inferred pain intensity is observed based on patient's pain behaviors during standardized, guided movements of different body parts (Part 1). In addition, MOBID-2 includes an observation of pain behavior related to internal organs, head and skin registered on pain drawings and monitored over time (Part 2). MOBID-2 has shown to be reliable, valid and time-effective to assess pain in patients with severe dementia. The investigators will use MOBID-2 for assessment of pain in all the patients with dementia. Scoring range is 0-10, the higher the score the more pain.
次要结局
- Stage of Dementia Disease(8 weeks)
- Neuropsychiatric Symptoms(8 weeks)
- The Total Daily Physical Activity(8 weeks)
- Depression(8 weeks)
- Aids of Daily Living(8 weeks)
- Level of Quality of Life: QUALID-scale(8 weeks)
研究者
Tone Rustøen
Professor
Oslo University Hospital