NCT04696211

Brief Summary

Background: The high prevalence of chronic pain in community-dwelling older adults requires attention from nurses. The aim of the present study is to use a music-with-movement exercise program to improve the pain situations of older adults with chronic pain. Aims and objectives: The aim of this study is to implement a music-with-movement exercise program (MMEP) for older adults suffering from chronic pain. The objectives of this study are:

  • To evaluate the effects of a music-with-movement exercise program on improving the pain intensity, pain self-efficacy, mood, and quality of life of the older adults with chronic pain
  • To observe the participants' level of adherence to the music-with-movement exercise by using an exercise logbook and measurements of heart rate Anticipated outcomes: This study will be a pilot randomized controlled trial. An 8-week music-with-movement exercise program will be used as the intervention for older adults with chronic pain in District Elderly Centers in Hong Kong. It will consist of four sessions of center-based, face-to-face activities and four weeks home-based and digital-based activities delivered through a WhatsApp group. A music therapist, in consultation with the physiotherapist, will lead the center-based activities. Each center-based session will consist of 30 minutes of music-with-movement exercise and 10 minutes of instruction on pain knowledge and pain management. Each participant will receive an exercise logbook to practice and record the frequency of their engagement in the music-with-movement exercise at home. They will receive WhatsApp reminders to remind them to continue the home-based sessions. Outcome measures include pain intensity, pain self-efficacy, mood, heart rate and physical activity intensity, and quality of life. Data will be collected before and after the intervention. Participants need to complete the exercise logbook to record their adherence to the intervention. The findings of this study will provide clinical implications for nurses to integrate music with movement exercise to manage pain.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P50-P75 for not_applicable chronic-pain

Timeline
Completed

Started Apr 2021

Typical duration for not_applicable chronic-pain

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 4, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 6, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

April 1, 2021

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
Last Updated

January 6, 2021

Status Verified

January 1, 2021

Enrollment Period

2.5 years

First QC Date

January 4, 2021

Last Update Submit

January 4, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Pain intensity

    Changes from baseline to Week 8 in pain intensity using the Chinese version of Brief Pain Inventory (BPI-C)

    Baseline, Week 8

Secondary Outcomes (4)

  • Pain self-efficacy

    Baseline, Week 8

  • Loneliness

    Baseline, Week 8

  • Depression

    Baseline, Week 8

  • Satisfaction and acceptability

    Week 8

Study Arms (2)

Experimental group

EXPERIMENTAL

The music-with-movement exercise program (MMEP) is an 8-week program. In the first 4 weeks a center-based program will be offered in the District Elderly Centers, and from week 1 to week 8 home-based and digital-based activities will be delivered via a WhatsApp group.

Other: Music-with-movement exercise

Control group

NO INTERVENTION

The participants in the control group will continue to receive their usual care and receive a one-page pain management pamphlet.

Interventions

A music-with-movement exercise programme to reduce chronic pain in older adults.

Experimental group

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 60 or above
  • Can understand Cantonese
  • Have a history of non-cancer pain in the past 3 months
  • Have a pain score of at least 2 as measured by the Numeric Rating Scale (on an 11-point numeric scale)
  • Able to take part in an exercise and stretching program
  • Owns a smartphone and can access the Internet

You may not qualify if:

  • Have severe visual and/or auditory deficits
  • Have a serious organic disease or malignant tumor
  • Have a mental disorder diagnosed by neurologists or psychiatrists
  • Had surgical treatments in the past two months
  • Experienced drug addiction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Chronic PainAgnosia

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Study Officials

  • Mimi MY Tse, PhD

    School of Nursing, The Hong Kong Polytechnic University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mimi MY Tse, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 4, 2021

First Posted

January 6, 2021

Study Start

April 1, 2021

Primary Completion

October 1, 2023

Study Completion

October 1, 2023

Last Updated

January 6, 2021

Record last verified: 2021-01