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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
The Hong Kong Polytechnic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chronic Pain

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    January 4, 2021
    Last Updated
    January 4, 2021
    Sponsor
    The Hong Kong Polytechnic University
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    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

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    A Music-with-movement Exercise Program for Community-dwelling Older Adults Suffering From Chronic Pain: a Pilot Randomized Controlled Trial

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