Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 9:07 PM
Study NCT ID:
NCT07456618
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-06
First Post:
2026-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Using Music During Wound Care Among Seniors With Pressure Injuries
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003668', 'term': 'Pressure Ulcer'}], 'ancestors': [{'id': 'D012883', 'term': 'Skin Ulcer'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'For one of the outcomes, the photo-based analysis, the outcomes assessors will be blinded. The study is otherwise not blinded.'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'One group will listen to music before/during wound care, the other will not.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2027-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-03', 'studyFirstSubmitDate': '2026-02-26', 'studyFirstSubmitQcDate': '2026-03-03', 'lastUpdatePostDateStruct': {'date': '2026-03-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Exploratory photo analysis', 'timeFrame': 'Measured weekly, up to 6 months.', 'description': '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.\n\nThey will state whether they think the participant was in the intervention or control group, and any additional comments about the wound healing.'}], 'primaryOutcomes': [{'measure': 'Presence of wound pain during dressing change', 'timeFrame': 'At each dressing change (weekly or every 2-3 days, depending on the participant), up to 6 months.', 'description': 'Measured as yes/no.'}, {'measure': 'Frequency of wound pain during dressing changes', 'timeFrame': 'At each dressing change, up to 6 months.', 'description': 'Measured categorically as none/intermittent/at dressing/ continuous.'}], 'secondaryOutcomes': [{'measure': 'Wound area', 'timeFrame': 'Measured weekly for up to 6 months.', 'description': 'Wound length and width will be combined to report area in cm\\^2.'}, {'measure': 'Time to complete healing', 'timeFrame': 'Measured for up to 6 months.', 'description': "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)."}, {'measure': "Caregivers' perceptions", 'timeFrame': 'Measured weekly for up to 6 months.', 'description': "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."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pressure Ulcer', 'Pressure Injury', 'Music', 'Wound Care', 'Long-Term Care', 'Aged', 'Quality of Life'], 'conditions': ['Pressure Injuries', 'Pressure Injury', 'Pressure Ulcer (PU)']}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.\n\nThe 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.\n\nThe main questions this study aims to answer are:\n\nDoes 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.\n\nThe 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.\n\nParticipants 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.\n\nParticipants in homes using music will:\n\nListen 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.\n\nInformation 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.\n\nParticipants 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 60 years or older\n* Has a stage II, III, or IV pressure injury\n\nExclusion Criteria:\n\n* Designated as end of life and/or has a Kennedy terminal pressure injury\n* Has an unstageable pressure injury\n* The pressure injury has necrotic tissue or necrotic bone present\n* The pressure injury is infected\n* The pressure injury is caused by a medical device in that area\n* Severe to profound hearing loss that is not corrected by a hearing aid or other assistive hearing device.'}, 'identificationModule': {'nctId': 'NCT07456618', 'briefTitle': 'Using Music During Wound Care Among Seniors With Pressure Injuries', 'organization': {'class': 'OTHER', 'fullName': 'McMaster University'}, 'officialTitle': 'Investigating the Use of Music During Wound Care', 'orgStudyIdInfo': {'id': '19584'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Music intervention arm', 'description': '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.', 'interventionNames': ['Other: Music listening']}, {'type': 'NO_INTERVENTION', 'label': 'Control arm', 'description': 'Participants in this group will receive standard wound care.'}], 'interventions': [{'name': 'Music listening', 'type': 'OTHER', 'description': "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.", 'armGroupLabels': ['Music intervention arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'L7S 1X2', 'city': 'Burlington', 'state': 'Ontario', 'country': 'Canada', 'contacts': [{'name': 'Sandy Croley', 'role': 'CONTACT', 'email': 'sandycroley@kinderaliving.ca', 'phone': '416-479-4345'}], 'facility': 'Wellington Park Care Centre', 'geoPoint': {'lat': 43.38621, 'lon': -79.83713}}, {'zip': 'N0A 1H0', 'city': 'Hagersville', 'state': 'Ontario', 'country': 'Canada', 'contacts': [{'name': 'Sandy Croley', 'role': 'CONTACT', 'email': 'sandycroley@kinderaliving.ca', 'phone': '416-479-4345'}], 'facility': 'Anson Place Care Centre', 'geoPoint': {'lat': 42.96681, 'lon': -80.04965}}, {'zip': 'L8G 1J3', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'contacts': [{'name': 'Sandy Croley', 'role': 'CONTACT', 'email': 'sandycroley@kinderaliving.ca', 'phone': '416-479-4345'}], 'facility': 'Arbour Creek Care Centre', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 'L8R 3L8', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'contacts': [{'name': 'Sandy Croley', 'role': 'CONTACT', 'email': 'sandycroley@kinderaliving.ca', 'phone': '416-479-4345'}], 'facility': 'Dundurn Place Care Centre', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 'L5B 1B5', 'city': 'Mississauga', 'state': 'Ontario', 'country': 'Canada', 'contacts': [{'name': 'Sandy Croley', 'role': 'CONTACT', 'email': 'sandycroley@kinderaliving.ca', 'phone': '416-479-4345'}], 'facility': 'Cooksville Care Centre', 'geoPoint': {'lat': 43.5789, 'lon': -79.6583}}, {'zip': 'M3N 1M9', 'city': 'North York', 'state': 'Ontario', 'country': 'Canada', 'contacts': [{'name': 'Sandy Croley', 'role': 'CONTACT', 'email': 'sandycroley@kinderaliving.ca', 'phone': '416-479-4345'}], 'facility': 'Hawthorne Place Care Centre'}, {'zip': 'L8E 5J2', 'city': 'Stoney Creek', 'state': 'Ontario', 'country': 'Canada', 'contacts': [{'name': 'Sandy Croley', 'role': 'CONTACT', 'email': 'sandycroley@kinderaliving.ca', 'phone': '416-479-4345'}], 'facility': 'Orchard Terrace Care Centre', 'geoPoint': {'lat': 43.21681, 'lon': -79.76633}}, {'zip': 'N7G 2A8', 'city': 'Strathroy', 'state': 'Ontario', 'country': 'Canada', 'contacts': [{'name': 'Sandy Croley', 'role': 'CONTACT', 'email': 'sandycroley@kinderaliving.ca', 'phone': '416-479-4345'}], 'facility': 'Sprucedale Care Centre', 'geoPoint': {'lat': 42.9551, 'lon': -81.62232}}, {'zip': 'M9B 3Z9', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'contacts': [{'name': 'Sandy Croley', 'role': 'CONTACT', 'email': 'sandycroley@kinderaliving.ca', 'phone': '416-479-4345'}], 'facility': 'Eatonville Care Centre', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'N8N 0B3', 'city': 'Windsor', 'state': 'Ontario', 'country': 'Canada', 'contacts': [{'name': 'Sandy Croley', 'role': 'CONTACT', 'email': 'sandycroley@kinderaliving.ca', 'phone': '416-479-4345'}], 'facility': 'Banwell Gardens Care Centre', 'geoPoint': {'lat': 42.30008, 'lon': -83.01654}}, {'zip': 'N9A 4P4', 'city': 'Windsor', 'state': 'Ontario', 'country': 'Canada', 'contacts': [{'name': 'Sandy Croley', 'role': 'CONTACT', 'email': 'sandycroley@kinderaliving.ca', 'phone': '416-479-4345'}], 'facility': 'Berkshire Care Centre', 'geoPoint': {'lat': 42.30008, 'lon': -83.01654}}], 'centralContacts': [{'name': 'Sinead George', 'role': 'CONTACT', 'email': 'georgs19@mcmaster.ca', 'phone': '(905) 525-9140', 'phoneExt': '20705'}], 'overallOfficials': [{'name': 'Chelsea Mackinnon', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'McMaster University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'We believe that for the purposes of reporting outcomes in this study, aggregate data will be sufficient.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'McMaster University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Kindera Living', 'class': 'UNKNOWN'}, {'name': 'Room 217 Foundation', 'class': 'UNKNOWN'}, {'name': "Queen's University", 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Sessional Instructor', 'investigatorFullName': 'Chelsea Mackinnon', 'investigatorAffiliation': 'McMaster University'}}}}