Music Based Caregiving in Patients With Pain and Dementia

University of Oslo (UIO)

Status: Completed

Conditions: Quality of Life; Music; Activity, Motor; Dementia; Pain

Treatments: Behavioral: Music based caregiving

Study type: Interventional

Funder types: Other

Identifiers

NCT04229446

2018/2519

Details and patient eligibility

About

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.

Full 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.

Enrollment: 276 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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).

Exclusion criteria

• 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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276 participants in 2 patient groups

Receive the music based intervention

Experimental group

Description:

After the healthcare workers have accomplished the MBC program the eight week intervention program will be applied by the trained staff at the intervention wards. The intervention (MBC) consists of daily individualized prerecorded music integrated with activity with about 30 minutes duration, combined with a one hour active session in groups twice weekly. The music will be selected based on individualized preferences from the patients or their family. The music will also be adapted to the day rhythm; awakening in the morning, support activities during the day, or for sleep in the evening. The healthcare worker will bring playback equipment e.g. a CD-player to the patient room. In addition will two weekly sessions in groups be performed (each on one hour) with music and movement. The movement will be adapted to their physical capacity.

Treatment:

Behavioral: Music based caregiving

Standard care group

No Intervention group

Description:

Standard care for participants in this group