- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07459855
This is a Study to Find Out Whether Music Therapy Can Reduce Stress During Wound Care
March 3, 2026 updated by: Ente Ospedaliero Cantonale, Bellinzona
Music Therapy to Reduce Stress and Increase Satisfaction in Patients Undergoing Surgical Wound Dressings in the In-hospital Setting: a Randomized Study
This study involves hospitalized patients who need wound dressing procedures.
Patients will be assigned by chance to one of two groups.
One group will listen to music of their choice during wound care, while the other group will receive standard wound care without music.
The investigators will then compare the two groups to see whether listening to music helps reduce stress and improve the experience during the procedure.
Study Overview
Study Type
Interventional
Enrollment (Estimated)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Davide La Regina, MD
- Phone Number: 0041918119106
- Email: ricerca.chirurgiaorl@eoc.ch
Study Locations
-
-
-
Bellinzona, Switzerland
- Recruiting
- Ospedale Regionale Bellinzona e Valli, Ente Ospedaliero Cantonale
-
Contact:
- Davide La Regina, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Hospitalized patients undergoing wound dressing procedures
- Age ≥ 18 years
Exclusion Criteria:
- Pregnant or lactating women
- Cognitive impairment or language barriers
- Severe hearing impairment
- Clinical instability requiring urgent medical intervention at the time of wound dressing
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: music listening
patient-selected music during wound dressing
|
patient-selected music
|
|
No Intervention: no music listened
standard care without music
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
change in heart rate
Time Frame: periprocedural
|
periprocedural
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
change in blood pressure
Time Frame: periprocedural
|
periprocedural
|
|
|
change in respiratory rate
Time Frame: periprocedural
|
periprocedural
|
|
|
change in oxygen saturation
Time Frame: periprocedural
|
periprocedural
|
|
|
pain intensity
Time Frame: periprocedural
|
Patient-reported outcomes.
Patient-reported pain intensity is assessed using the Numerical Rating Scale (NRS; range 0-10).
The Numerical Rating Scale is a scale ranging from 0 (no pain) to 10 (worst imaginable pain).
Higher scores indicate greater pain intensity and therefore represent a worse outcome.
|
periprocedural
|
|
perceived anxiety
Time Frame: periprocedural
|
Patient-reported outcomes, assessed using a Numerical Rating Scale (NRS, 0-10).
The Numerical Rating Scale is a scale ranging from 0 (no anxiety) to 10 (worst imaginable anxiety).
Higher scores indicate greater anxiety and therefore represent a worse outcome.
|
periprocedural
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Davide La Regina, MD, EOC
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
February 11, 2026
Primary Completion (Estimated)
May 31, 2026
Study Completion (Estimated)
May 31, 2026
Study Registration Dates
First Submitted
February 16, 2026
First Submitted That Met QC Criteria
March 3, 2026
First Posted (Actual)
March 10, 2026
Study Record Updates
Last Update Posted (Actual)
March 10, 2026
Last Update Submitted That Met QC Criteria
March 3, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ORBV-CHIR-009
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.
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