A Music-with-movement Exercise Program for Community-dwelling Older Adults Suffering From Chronic Pain: a Pilot Randomized Controlled Trial
Primary Purpose
Chronic Pain, Elderly, Music-with-movement Exercise
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Music-with-movement exercise
Sponsored by
About this trial
This is an interventional supportive care trial for Chronic Pain
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Experimental group
Control group
Arm Description
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.
The participants in the control group will continue to receive their usual care and receive a one-page pain management pamphlet.
Outcomes
Primary Outcome Measures
Pain intensity
Changes from baseline to Week 8 in pain intensity using the Chinese version of Brief Pain Inventory (BPI-C)
Secondary Outcome Measures
Pain self-efficacy
Changes from baseline to Week 8 in pain self-efficacy using the Chinese version of Pain Self-efficacy Questionnaire
Loneliness
Changes from baseline to Week 8 in loneliness using the Chinese version of De Jong Gierveld Loneliness Scale
Depression
Changes from baseline to Week 8 in depression using the Chinese version of Geriatric Depression Scale
Satisfaction and acceptability
Questions designed by the research team to collect the participants' satisfaction and acceptability
Full Information
NCT ID
NCT04696211
First Posted
January 4, 2021
Last Updated
January 4, 2021
Sponsor
The Hong Kong Polytechnic University
1. Study Identification
Unique Protocol Identification Number
NCT04696211
Brief Title
A Music-with-movement Exercise Program for Community-dwelling Older Adults Suffering From Chronic Pain: a Pilot Randomized Controlled Trial
Official Title
A Music-with-movement Exercise Program for Community-dwelling Older Adults Suffering From Chronic Pain: a Pilot Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2021 (Anticipated)
Primary Completion Date
October 1, 2023 (Anticipated)
Study Completion Date
October 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hong Kong Polytechnic University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain, Elderly, Music-with-movement Exercise, Pain Management
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The participants in the control group will continue to receive their usual care and receive a one-page pain management pamphlet.
Intervention Type
Other
Intervention Name(s)
Music-with-movement exercise
Intervention Description
A music-with-movement exercise programme to reduce chronic pain in older adults.
Primary Outcome Measure Information:
Title
Pain intensity
Description
Changes from baseline to Week 8 in pain intensity using the Chinese version of Brief Pain Inventory (BPI-C)
Time Frame
Baseline, Week 8
Secondary Outcome Measure Information:
Title
Pain self-efficacy
Description
Changes from baseline to Week 8 in pain self-efficacy using the Chinese version of Pain Self-efficacy Questionnaire
Time Frame
Baseline, Week 8
Title
Loneliness
Description
Changes from baseline to Week 8 in loneliness using the Chinese version of De Jong Gierveld Loneliness Scale
Time Frame
Baseline, Week 8
Title
Depression
Description
Changes from baseline to Week 8 in depression using the Chinese version of Geriatric Depression Scale
Time Frame
Baseline, Week 8
Title
Satisfaction and acceptability
Description
Questions designed by the research team to collect the participants' satisfaction and acceptability
Time Frame
Week 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mimi MY Tse, PhD
Phone
852 2766 6541
Email
mimi.tse@polyu.edu.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mimi MY Tse, PhD
Organizational Affiliation
School of Nursing, The Hong Kong Polytechnic University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
A Music-with-movement Exercise Program for Community-dwelling Older Adults Suffering From Chronic Pain: a Pilot Randomized Controlled Trial
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