Chronic PainNCT04696211
A Music-with-movement Exercise Program for Community-dwelling Older Adults Suffering From Chronic Pain: a Pilot Randomized Controlled Trial
A study testing Music-with-movement exercise in people with Chronic Pain and Elderly, run by The Hong Kong Polytechnic University.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Pain, Elderly, Music-with-movement Exercise
- What is being tested?
- Music-with-movement exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2021to 1 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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:
Read more
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.
- Conditions
- Chronic Pain, Elderly, Music-with-movement Exercise, Pain Management
- Being tested
- Music-with-movement exercise
- Medical subject headings
- Chronic Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music-with-movement exerciseOther
A music-with-movement exercise programme to reduce chronic pain in older adults.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
Changes from baseline to Week 8 in pain intensity using the Chinese version of Brief Pain Inventory (BPI-C)
Measured: Baseline, Week 8
Secondary outcomes (4)
Pain self-efficacy
Changes from baseline to Week 8 in pain self-efficacy using the Chinese version of Pain Self-efficacy Questionnaire
Measured: Baseline, Week 8
Loneliness
Changes from baseline to Week 8 in loneliness using the Chinese version of De Jong Gierveld Loneliness Scale
Measured: Baseline, Week 8
Depression
Changes from baseline to Week 8 in depression using the Chinese version of Geriatric Depression Scale
Measured: Baseline, Week 8
Satisfaction and acceptability
Questions designed by the research team to collect the participants' satisfaction and acceptability
Measured: Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2021
- Study start1 Apr 2021 (estimated)
- Primary completion1 Oct 2023 (estimated)
- Study completion1 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, TSE Mun Yee Mimi, The Hong Kong Polytechnic University
- Investigators
- Mimi MY Tse, PhD, Principal investigator, School of Nursing, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04696211
- Sponsor's protocol ID
- MMEP
- Status last verified
- Jan 2021
- First submitted
- 4 Jan 2021
- Last updated
- 6 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Music-with-movement Exercise Program for Community-dwelling Older Adults Suffering From Chronic Pain: a Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04696211
- Acronym / sponsor ID
- MMEP
- Conditions
- Chronic Pain, Elderly, Music-with-movement Exercise, Pain Management
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 1 Apr 2021 (estimated)
- Primary completion
- 1 Oct 2023 (estimated)
- Study completion
- 1 Oct 2023 (estimated)
- First posted
- 6 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Music-with-movement exerciseThe 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. |
| 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music-with-movement exerciseA music-with-movement exercise programme to reduce chronic pain in older adults. | Other | Experimental group |
Primary outcome
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)
4 secondary outcomes
Pain self-efficacy
Time frame: Baseline, Week 8
Loneliness
Time frame: Baseline, Week 8
Depression
Time frame: Baseline, Week 8
Satisfaction and acceptability
Time frame: Week 8
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mimi MY Tse, PhD principal investigator
School of Nursing, The Hong Kong Polytechnic University
Questions about this trial
What is this clinical trial studying?
A study testing Music-with-movement exercise in people with Chronic Pain and Elderly, run by The Hong Kong Polytechnic University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mimi MY Tse, PhD (852 2766 6541, mimi.tse@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: Baseline, Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2021.