Individualized Music Playlist Based on ISO Principle for De-escalation of Agitation in Dementia

Dementia Clinical Trial

Official title:

The Effects of an Individualized Music Playlist Based on the ISOPrinciple for the Immediate De-escalation of Agitation in People With Dementia: a Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06104436
• Other study ID #: A0047147
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: December 31, 2026

Study information

• Verified date: September 2023
• Source: The Hong Kong Polytechnic University
• Contact: Daphne Sze Ki Cheung, PhD
• Phone: +852 27664534
• Email: daphne.cheung[@]polyu.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical trial is to evaluate the efficacy of an Individualized Music Playlist (InMP) composed of preferred music genres sequenced according to the ISO-Principle, for the immediate de-escalation of agitation in dementia, compared with preferred music (PM) and treatment as usual (TAU).

Description:

1. Study design

• Randomized controlled trial

2. Participants

• Eighty-one older adults living with dementia and demonstrate significant agitation

3. Setting:

• Residential care home

4. Intervention

• Individualized music listening intervention played with an iPad and a wireless neckband speaker for 30 minutes when agitation begins in addition to usual care.

5. Comparison conditions

• Preferred music listening group: Preferred music listening played with an iPad and a wireless neckband speaker for 30 minutes when agitation begins in addition to usual care.

• Usual care group: usual care

6. Outcomes

• Level of agitation measured with the Pittsburgh Agitation Scale

• Intensity of agitation measured with the Positive and Negative Syndrome Scale - Excited Component

• Agitation occurrence frequency measured with Cohen-Mansfield Agitation Inventory

• Distress of formal caregivers related to agitation measured with Neuropsychiatric Inventory

7. Focus group interviews with the care staff will be conducted as a process evaluation for identifying the potential facilitators and barriers related to implementation.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 81
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• residents in long-term care facilities

• diagnosed with any type of dementia

• presented with significant agitation

Exclusion Criteria:

• had been admitted to the facility for less than three months

• are participating in other studies or experimental therapies

• have a comorbid psychiatric illness

• have physical illness that prevents them from listening to music

Related Conditions & MeSH terms

• Dementia
• Psychomotor Agitation

Intervention

Behavioral:
• Individualized music playlist
Individualized music playlist composed of preferred music genres sequenced according to the ISO-Principle. It will be played at the state of agitation.
• Preferred music
Preferred music is composed of the genres selected by the participants, and to be played at random sequence.
• Usual care
Usual technique for calming agitated older adults with dementia

Locations

Country	Name	City	State
Hong Kong	School of Nursing, The Hong Kong Polytechnic University	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Challenges and enablers in the implementation of the intervention	Semi-structured focus group interviews with the carers will be conducted.	6 weeks
Primary	Level of agitation	Positive and Negative Syndrome Scale - Excitatory Component will be used for assessing the level of agitation. It consists of 5 items: excitement, tension, hostility, uncooperativeness, and poor impulse control. The 5 items from the PANSS-EC are rated from 1 (not present) to 7 (extremely severe); scores range from 5 to 35; mean scores = 20 clinically correspond to severe agitation.	6 weeks
Primary	Intensity of agitation	Pittsburgh Agitation Scale will be used to assess the intensity of agitation. It is a brief measure of agitation that measures the severity of agitation in four general categories: aberrant vocalisation, motor agitation, aggressiveness and resisting care, on a scale from 0 (not present) to 4 (highest level).	6 weeks
Primary	Agitation status	Behavioural Activity Rating Scale will be used to assess the agitation status. It contains a single-item question consisting of seven categories: 1=difficult or unable to rouse; 2=asleep, but responds normally to verbal or physical contact; 3=drowsy, appears sedated; 4=quiet and awake (normal level of activity); 5=signs of overt (physical or verbal) activity, calms down with instruction; 6=extremely or continuously active, not requiring restraint; 7=violent, requires restraint.	6 weeks
Secondary	Agitation occurrence	Cohen-Mansfield Agitation Inventory will be used to assess the agitation occurence. A total CMAI score is obtained by summing all the individual items, giving a range from 29 to 203. A total score of >45 is usually regarded as clinically significant agitation.	6 weeks
Secondary	Emotional or psychological distress of carer	Neuropsychiatry Inventory Questionnaire will be used to assess the distress of caregivers. Caregiver distress is rated for each positive neuropsychiatric symptom domain on a scale anchored by scores from 0 to 5 points (0=no distress; 1=minimal distress; 2=mild distress; 3=moderate distress; 4=severe distress; and 5=very severe distress), giving a maximum score of 60.	6 weeks