Music Based Caregiving in Patients With Pain and Dementia

NCT04229446 | Completed Results

• 1 other identifier: 2018/2519
• Study Type: interventional
• Target: 276
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Pain Occurence

  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.

  8 weeks

Secondary Outcomes (6)

• The Total Daily Physical Activity

  8 weeks

• Stage of Dementia Disease

  8 weeks

• Neuropsychiatric Symptoms

  8 weeks

• Depression

  8 weeks

• Level of Quality of Life: QUALID-scale

  8 weeks

Study Arms (2)

Receive the music based intervention

EXPERIMENTAL

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.

Behavioral: Music based caregiving

Standard care group

NO INTERVENTION

Standard care for participants in this group

Interventions

Music based caregiving BEHAVIORAL

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.

Receive the music based intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oslo University Hospital: lead
• Helse Midt-Norge: collaborator
• St. Olavs Hospital: collaborator
• University of Oslo: collaborator
• University of Bergen: collaborator
• Norwegian Centre for Ageing and Health: collaborator

Study Sites (2)

Oslo University Hospital

Oslo, Norway

Location

St. Olavs hospital Trondheim University Hospital

Trondheim, Norway

Location

Related Publications (2)

• Myrenget ME, Rustoen T, Myskja A, Smastuen M, Rangul V, Hapnes O, Borchgrevink PC, Butler S, Selbaek G, Husebo B, Sandvik R. The effect of a music-based caregiving intervention on pain intensity in nursing home patients with dementia: a cluster-randomized controlled study. Pain. 2024 Jul 1;165(7):1550-1558. doi: 10.1097/j.pain.0000000000003156. Epub 2024 Jan 2.

  PMID: 38189182 DERIVED

• Myrenget ME, Borchgrevink PC, Rustoen T, Butler S, Thorsvik D, Smastuen MC, Sandvik R. Chronic pain conditions and use of analgesics among nursing home patients with dementia. Pain. 2023 May 1;164(5):1002-1011. doi: 10.1097/j.pain.0000000000002794. Epub 2022 Dec 21.

  PMID: 36542760 DERIVED

MeSH Terms

Conditions

Pain; Dementia; Motor Activity

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Behavior

Limitations and Caveats

-Possible selection bias 1. Patients selected from 12 different nursing homes in 2 different cities in Norway using different selection strategies. In Oslo, an invitation email was sent to all nursing homes, and the ones interested responded, whereas in Trondheim, the nursing homes were chosen by the municipality. 2. Our study does not include nursing homes from rural areas and thus may not be truly representative for the general nursing home population in Norway

Results Point of Contact

• Title: Primary Investigator Dr. Tone Rustøen
• Organization: OsloUH

tone.rustoen@medisin.uio.no

+47 22859229

Study Officials

• Tone Rustøen, PhD

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The included statistician will do the first evaluation of the results
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This is a cluster-randomized controlled trial including patients with dementia and pain living at different wards at nursing homes.

Study Record Dates

• First Submitted: October 9, 2019
• First Posted: January 18, 2020
• Study Start: August 5, 2019
• Primary Completion: August 5, 2020
• Study Completion: August 5, 2020
• Last Updated: December 7, 2023
• Results First Posted: December 7, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

NO (2)