Music Based Caregiving in Patients With Pain and Dementia

Pain Clinical Trial

Official title:

In What Way do Music-based Caregiving Influence Pain, Daily Activity, QOL, Neuropsychiatric Symptoms, and Medication in Patients With Dementia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04229446
• Other study ID #: 2018/2519
• Status: Completed
• Phase: N/A
• Start date: August 5, 2019
• Est. completion date: August 5, 2020

Study information

• Verified date: February 2023
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 276
• Est. completion date: August 5, 2020
• Est. primary completion date: August 5, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Music based caregiving
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.

Locations

Country	Name	City	State
Norway	Oslo University Hospital	Oslo
Norway	St. Olavs hospital Trondheim University Hospital	Trondheim

Sponsors (6)

Lead Sponsor	Collaborator
Oslo University Hospital	Helse Midt-Norge, Norwegian Centre for Ageing and Health, St. Olavs Hospital, University of Bergen, University of Oslo

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The Total Daily Physical Activity	Two three-axis accelerometers attached to the skin on the right thigh and low back for seven continuous days. By utilizing state-of-the-art machine-learning techniques, the investigators have developed a preliminary activity recognition model for lying, sitting, standing, walking and other activities. This model has been used in the Nord-Trøndelag health study (HUNT4). Specifically, the model captures walking velocity and transitions between postures and activities (e.g. sit-to-stand) and sleep quality/duration.	8 weeks
Secondary	Stage of Dementia Disease	Clinical Dementia Rating Scale (CDR) is an assessment scale for the accurate clinical staging of dementia in older subjects. The CDR includes six items assessing cognitive and functional impairment. Based on an algorithm giving precedence to the item memory a total score is estimated. A score of 0, 0.5, 1, 2, 3 indicates no dementia, questionable dementia, mild, moderate or severe dementia, respectively, and CDR score > 1, is cut-off score for dementia disease. The scale has shown to be reliable and valid, also the Norwegian version.	8 weeks
Secondary	Neuropsychiatric Symptoms	The Neuropsychiatric Inventory (NPI-NH) measure 12 different psychiatric symptoms and behavioural disturbances in nursing home residents: delusions, hallucinations, dysphoria, anxiety, agitation/aggression, euphoria, disinhibition, irritability/lability, apathy, aberrant motor activity, sleep and night-time behaviour disorders, appetite and eating disorders. The screening question is asked to determine if the behavioural change is present. If a screening question is present, there will be sub-questions about frequency (score 1 to 4) and intensity (score 1 to 3) for each behavior. Total score for each behavior is from 1 to 12. The total scoring range is from 0-144, the higher the score the more symptoms. The scale has been validated for patients in nursing homes in Norway.	8 weeks
Secondary	Depression	Cornell scale for depression in dementia assesses signs and symptoms of major depression in patients with dementia in an interview with the health care providers. The scale consists of 19 items in five domains based on observation of behaviour. Each question is scored on a two-point scale: 0=absent; 1=mild or intermittent; 2=severe; n/a = unable to evaluate.	8 weeks
Secondary	Level of Quality of Life: QUALID-scale	Quality of Life in Late-Stage Dementia (QUALID) measures QOL in patients with severe dementia based on information and observations from nurses about the patient's emotions and behavior. Dementia Quality of Life (DQoL) will also be used as QUALID-scale is an observation scale, and there is a lack of studies comparing self-reported and observations QoL in those with dementia, the investigators want to compare the observation estimate with self-report for patients with none, mild and moderate dementia (DQoL). DQoL consists of five domains: self-esteem, positive affect/ humor, feeling of belonging, and sense of aesthetics and negative affect. The instrument is evaluated in those with mild and moderate dementia and is used in nursing homes in Norway. Scoring range is from 11-55, the higher the score the worse QOL.	8 weeks
Secondary	Aids of Daily Living	Barthel's Activities of Daily Living Index (ADL) is a screening instrument for patients' daily life functioning. This 10-point scale measures patients' degree of self-reliance with a total score ranging from 0 to 20. Lower scores indicate greater dependence on nursing care.	8 weeks