NCT07456618

Brief Summary

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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
12mo left

Started Apr 2026

Geographic Reach
1 country

11 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress12%
Apr 2026Jun 2027

First Submitted

Initial submission to the registry

February 26, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 6, 2026

Completed
26 days until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

March 6, 2026

Status Verified

March 1, 2026

Enrollment Period

6 months

First QC Date

February 26, 2026

Last Update Submit

March 3, 2026

Conditions

Keywords

Pressure UlcerPressure InjuryMusicWound CareLong-Term CareAgedQuality of Life

Outcome Measures

Primary Outcomes (2)

  • Presence of wound pain during dressing change

    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

    Measured categorically as none/intermittent/at dressing/ continuous.

    At each dressing change, up to 6 months.

Secondary Outcomes (3)

  • Wound area

    Measured weekly for up to 6 months.

  • Time to complete healing

    Measured for up to 6 months.

  • Caregivers' perceptions

    Measured weekly for up to 6 months.

Other Outcomes (1)

  • Exploratory photo analysis

    Measured weekly, up to 6 months.

Study Arms (2)

Music intervention arm

EXPERIMENTAL

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.

Other: Music listening

Control arm

NO INTERVENTION

Participants in this group will receive standard wound care.

Interventions

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.

Music intervention arm

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years or older
  • Has a stage II, III, or IV pressure injury

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Wellington Park Care Centre

Burlington, Ontario, L7S 1X2, Canada

Location

Anson Place Care Centre

Hagersville, Ontario, N0A 1H0, Canada

Location

Arbour Creek Care Centre

Hamilton, Ontario, L8G 1J3, Canada

Location

Dundurn Place Care Centre

Hamilton, Ontario, L8R 3L8, Canada

Location

Cooksville Care Centre

Mississauga, Ontario, L5B 1B5, Canada

Location

Hawthorne Place Care Centre

North York, Ontario, M3N 1M9, Canada

Location

Orchard Terrace Care Centre

Stoney Creek, Ontario, L8E 5J2, Canada

Location

Sprucedale Care Centre

Strathroy, Ontario, N7G 2A8, Canada

Location

Eatonville Care Centre

Toronto, Ontario, M9B 3Z9, Canada

Location

Banwell Gardens Care Centre

Windsor, Ontario, N8N 0B3, Canada

Location

Berkshire Care Centre

Windsor, Ontario, N9A 4P4, Canada

Location

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin UlcerSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Chelsea Mackinnon

    McMaster University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Masking Details
For one of the outcomes, the photo-based analysis, the outcomes assessors will be blinded. The study is otherwise not blinded.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: One group will listen to music before/during wound care, the other will not.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Sessional Instructor

Study Record Dates

First Submitted

February 26, 2026

First Posted

March 6, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

June 1, 2027

Last Updated

March 6, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

We believe that for the purposes of reporting outcomes in this study, aggregate data will be sufficient.

Locations