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Clinical Trial Summary

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.


Clinical Trial Description

This is a cluster-randomized controlled trial including patients with dementia and pain living at different wards at eight nursing homes. 1. About 12 nursing homes are selected to participate in Trondheim and in Oslo. 2. 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). 3. 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. 4. 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. 5. After the pre-test - a randomization of the wards into intervention wards or control wards will be performed. 6. About five staff members at each of the wards randomized to the intervention group will receive education in the MBC before intervention. 7. A post-test just after the intervention has ended, pain, total daily physical activity, ADL, QOL, and neuropsychiatric symptoms will be measured. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04229446
Study type Interventional
Source Oslo University Hospital
Contact
Status Completed
Phase N/A
Start date August 5, 2019
Completion date August 5, 2020

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