- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04696211
A Music-with-movement Exercise Program for Community-dwelling Older Adults Suffering From Chronic Pain: a Pilot Randomized Controlled Trial
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Mimi MY Tse, PhD
- Phone Number: 852 2766 6541
- Email: mimi.tse@polyu.edu.hk
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental group
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.
|
A music-with-movement exercise programme to reduce chronic pain in older adults.
|
No Intervention: Control group
The participants in the control group will continue to receive their usual care and receive a one-page pain management pamphlet.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain intensity
Time Frame: Baseline, Week 8
|
Changes from baseline to Week 8 in pain intensity using the Chinese version of Brief Pain Inventory (BPI-C)
|
Baseline, Week 8
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain self-efficacy
Time Frame: Baseline, Week 8
|
Changes from baseline to Week 8 in pain self-efficacy using the Chinese version of Pain Self-efficacy Questionnaire
|
Baseline, Week 8
|
Loneliness
Time Frame: Baseline, Week 8
|
Changes from baseline to Week 8 in loneliness using the Chinese version of De Jong Gierveld Loneliness Scale
|
Baseline, Week 8
|
Depression
Time Frame: Baseline, Week 8
|
Changes from baseline to Week 8 in depression using the Chinese version of Geriatric Depression Scale
|
Baseline, Week 8
|
Satisfaction and acceptability
Time Frame: Week 8
|
Questions designed by the research team to collect the participants' satisfaction and acceptability
|
Week 8
|
Collaborators and Investigators
Investigators
- Principal Investigator: Mimi MY Tse, PhD, School of Nursing, The Hong Kong Polytechnic University
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MMEP
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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