Using Music During Wound Care Among Seniors With Pressure Injuries
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorMcMaster University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
60 years or older
Has a stage II, III, or IV pressure injury
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Music listening
Other interventionPersonalized 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.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Music intervention armExperimental treatment 1 intervention
Group B: Control armNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Presence of wound pain during dressing change
Measured as yes/no.
Time frame
At each dressing change (weekly or every 2-3 days, depending on the participant), up to 6 months.2
Frequency of wound pain during dressing changes
Measured categorically as none/intermittent/at dressing/ continuous.
Time frame
At each dressing change, up to 6 months.Secondary outcomes
1
Wound area
Wound length and width will be combined to report area in cm\^2.
Time frame
Measured weekly for up to 6 months.2
Time to complete healing
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).
Time frame
Measured for up to 6 months.3
Caregivers' perceptions
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.
Time frame
Measured weekly for up to 6 months.Other outcomes
1
Exploratory photo analysis
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.
Time frame
Measured weekly, up to 6 months.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
McMaster University
Lead sponsor
Kindera Living
Collaborator
Room 217 Foundation
Collaborator
Queen's University
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: