- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07456618
Using Music During Wound Care Among Seniors With Pressure Injuries
Investigating the Use of Music During Wound Care
Pressure injuries (also known as pressure wounds or bed sores) are increasingly common among older adults living in care homes. These wounds often require regular dressing changes, which can be uncomfortable for some.
The researchers believe that listening to music during wound care may have an effect on pain, wound healing, and the overall wound care experience, compared with wound care without music.
The goal of this clinical study is to test this idea by examining whether listening to music before and during wound care is linked to differences in pain, wound healing, and the overall wound care experience in older adults with pressure injuries.
The main questions this study aims to answer are:
Does listening to music before and during pressure injury care affect pain during wound care? Does listening to music before and during pressure injury care affect how pressure injuries heal over time? Does listening to music affect the overall experience of pressure injury care? Researchers will compare wound care with music to wound care without music to better understand whether music makes a difference.
The study will take place in eleven long-term care homes in Ontario. Participants will be residents aged 60 years and older who have a stage II, III, or IV pressure injury and who are already receiving regular wound care as part of their usual care. This study will not include residents who have infected or necrotic wounds, or who are at the end of life.
Participants will continue to receive the same wound care they would normally receive. Some homes will include music during wound care, and some homes will not.
Participants in homes using music will:
Listen to a playlist of music they personally enjoy for about 15 minutes before wound care begins Continue listening to the music during the wound care procedure Be able to change the volume or stop the music at any time Participants in homes not using music will receive the same standard pressure injury care without music.
Information for the study will come from clinical records that nurses already complete during routine wound care, such as notes about pain and wound healing. Staff involved in playing the music will also complete a short questionnaire about their observations of the wound care experience. Photos of wounds that are already taken as part of usual care may be reviewed to look at healing over time.
Participants may take part in the study for up to six months or until their wound has healed. Taking part is voluntary, and participants or their decision-makers can choose to stop at any time. The study does not change the medical care participants receive.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sinead George
- Phone Number: 20705 (905) 525-9140
- Email: georgs19@mcmaster.ca
Study Locations
-
-
Ontario
-
Burlington, Ontario, Canada, L7S 1X2
- Wellington Park Care Centre
-
Contact:
- Sandy Croley
- Phone Number: 416-479-4345
- Email: sandycroley@kinderaliving.ca
-
Hagersville, Ontario, Canada, N0A 1H0
- Anson Place Care Centre
-
Contact:
- Sandy Croley
- Phone Number: 416-479-4345
- Email: sandycroley@kinderaliving.ca
-
Hamilton, Ontario, Canada, L8G 1J3
- Arbour Creek Care Centre
-
Contact:
- Sandy Croley
- Phone Number: 416-479-4345
- Email: sandycroley@kinderaliving.ca
-
Hamilton, Ontario, Canada, L8R 3L8
- Dundurn Place Care Centre
-
Contact:
- Sandy Croley
- Phone Number: 416-479-4345
- Email: sandycroley@kinderaliving.ca
-
Mississauga, Ontario, Canada, L5B 1B5
- Cooksville Care Centre
-
Contact:
- Sandy Croley
- Phone Number: 416-479-4345
- Email: sandycroley@kinderaliving.ca
-
North York, Ontario, Canada, M3N 1M9
- Hawthorne Place Care Centre
-
Contact:
- Sandy Croley
- Phone Number: 416-479-4345
- Email: sandycroley@kinderaliving.ca
-
Stoney Creek, Ontario, Canada, L8E 5J2
- Orchard Terrace Care Centre
-
Contact:
- Sandy Croley
- Phone Number: 416-479-4345
- Email: sandycroley@kinderaliving.ca
-
Strathroy, Ontario, Canada, N7G 2A8
- Sprucedale Care Centre
-
Contact:
- Sandy Croley
- Phone Number: 416-479-4345
- Email: sandycroley@kinderaliving.ca
-
Toronto, Ontario, Canada, M9B 3Z9
- Eatonville Care Centre
-
Contact:
- Sandy Croley
- Phone Number: 416-479-4345
- Email: sandycroley@kinderaliving.ca
-
Windsor, Ontario, Canada, N8N 0B3
- Banwell Gardens Care Centre
-
Contact:
- Sandy Croley
- Phone Number: 416-479-4345
- Email: sandycroley@kinderaliving.ca
-
Windsor, Ontario, Canada, N9A 4P4
- Berkshire Care Centre
-
Contact:
- Sandy Croley
- Phone Number: 416-479-4345
- Email: sandycroley@kinderaliving.ca
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 60 years or older
- Has a stage II, III, or IV pressure injury
Exclusion Criteria:
- Designated as end of life and/or has a Kennedy terminal pressure injury
- Has an unstageable pressure injury
- The pressure injury has necrotic tissue or necrotic bone present
- The pressure injury is infected
- The pressure injury is caused by a medical device in that area
- Severe to profound hearing loss that is not corrected by a hearing aid or other assistive hearing device.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Music intervention arm
Participants in this group will have their personalized playlists (i.e., based on their musical preferences) played for them ~15 minutes before and during their standard wound care.
The participants can adjust the volume and/or pause the music at any time.
|
Personalized playlists of each individual resident's favourite music will be created.
This playlist will be played at the resident's preferred volume, using headphones if requested, 15 min before and during their wound care.
|
|
No Intervention: Control arm
Participants in this group will receive standard wound care.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Presence of wound pain during dressing change
Time Frame: At each dressing change (weekly or every 2-3 days, depending on the participant), up to 6 months.
|
Measured as yes/no.
|
At each dressing change (weekly or every 2-3 days, depending on the participant), up to 6 months.
|
|
Frequency of wound pain during dressing changes
Time Frame: At each dressing change, up to 6 months.
|
Measured categorically as none/intermittent/at dressing/ continuous.
|
At each dressing change, up to 6 months.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Wound area
Time Frame: Measured weekly for up to 6 months.
|
Wound length and width will be combined to report area in cm^2.
|
Measured weekly for up to 6 months.
|
|
Time to complete healing
Time Frame: Measured for up to 6 months.
|
Measured as time from the first documented instance of the wound in the individual's electronic medical record, to full epithelization (also reported in their chart).
|
Measured for up to 6 months.
|
|
Caregivers' perceptions
Time Frame: Measured weekly for up to 6 months.
|
Brief post-wound care questionnaire completed by the recreational team members where they will track their perceptions of the overall wound care experience.
Responses to Likert-scale items assessing observed comfort, distraction, and overall experience (ranging from strongly disagree to strongly agree, with an option of unable to observe).
For the intervention group, was music played (yes/no), and using the same above Likert-scale, whether the music had a positive effect on the resident's comfort and experience during wound care.
Space for a comment to elaborate as well.
|
Measured weekly for up to 6 months.
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Exploratory photo analysis
Time Frame: Measured weekly, up to 6 months.
|
Two blinded registered nurses will visually analyze the series of photos for each participant (with dates they were taken) and they will assess the healing of the wound on a scale of 0-10, 0 = Healing not as expected / worsening; 5 = Healing progressing as expected; 10 = Optimal healing / exceeds expectations. They will state whether they think the participant was in the intervention or control group, and any additional comments about the wound healing. |
Measured weekly, up to 6 months.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Chelsea Mackinnon, McMaster University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
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
- 19584
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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.
Clinical Trials on Pressure Injury
-
Coloplast A/SCompletedPressure Injury PreventionDenmark
-
Second Affiliated Hospital, School of Medicine,...RecruitingOral Mucosal Pressure InjuryChina
-
King Abdullah Medical CityRecruitingPressure Injury | Pressure Ulcer, Buttock | Pressure Injury Stage 2 | Pressure Ulcers Stage II | BedsoreSaudi Arabia
-
University of GaziantepCompletedNursing Education | Pressure Injury | Medical Device-Related Pressure InjuryTurkey (Türkiye)
-
Saglik Bilimleri UniversitesiEnrolling by invitationPressure Injury | Risk Assessment | Nursing Care | Pressure Injury PreventionTurkey (Türkiye)
-
National Taiwan University HospitalCompletedPressure Injury | Implementation | Alternating Pressure Air MattressTaiwan
-
Ankara Yildirim Beyazıt UniversityAnkara City Hospital BilkentCompletedPressure Injury PreventionTurkey
-
Taipei Medical University WanFang HospitalKaohsiung Medical University Chung-Ho Memorial Hospital; Oneness Biotech Co...Terminated
-
Istanbul Medipol University HospitalMedipol University; Kartal Dr. Lütfi Kirdar City HospitalRecruitingPressure Injury | Skin Lesions | Skin InjuryTurkey (Türkiye)
-
Mehmet Akif Ersoy UniversityMassachusetts College of Pharmacy and Health Science; University of Massachusetts...Not yet recruitingPressure Ulcer Prevention | Pressure InjuriesUnited States
Clinical Trials on Music listening
-
Anglia Ruskin UniversityCompletedDepression | Stress | Anxiety | Visual Impairment | Low Vision | Emotional AdjustmentUnited Kingdom
-
Inonu UniversityCompletedCancer | ChemotherapyTurkey
-
Cliniques universitaires Saint-Luc- Université...Completed
-
Selcuk UniversityCompletedPostoperative Pain | Cesarean Section; DehiscenceTurkey (Türkiye)
-
Aydin Adnan Menderes UniversityCompletedPain | Anxiety | Nurse's RoleTurkey
-
Erasmus Medical CenterCompleted
-
New York UniversityRecruiting
-
The Hong Kong Polytechnic UniversityCompleted
-
University of British ColumbiaNortheastern UniversityRecruiting
-
Turku University HospitalAcademy of FinlandCompleted