An interventional study of Music intervention Group 1 and Music intervention Group 2 in Pain, Blood Pressure and Heart Rate, sponsored by Azienda Unita Sanitaria Locale di Piacenza. Not yet recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-15.
Sponsored by Azienda Unita Sanitaria Locale di Piacenza · Not applicable, Interventional, and Treatment
This randomized controlled trial (RCT) evaluates the effectiveness of music as a complementary intervention for pain control during non-surgical reduction of distal radius fractures in orthopedic patients. Distal radius fractures are among the most common traumatic injuries presenting to emergency departments and are frequently associated with intense procedural pain and significant physiological stress responses. Despite standard pharmacological analgesia, optimal pain management during fracture reduction remains a clinical challenge, and evidence regarding non-pharmacological adjuncts in the emergency orthopedic setting is still limited The study will enroll 192 adult patients admitted to the orthopedic emergency departments of AUSL Piacenza and AOU Parma with distal radius fractures requiring closed reduction. Participants will be randomly assigned (1:1:1) to one of three groups: a 20-minute session of patient-preferred music, a 20-minute session of standardized music selected by a music therapist, or standard care without music. Pain intensity will be assessed using the Numerical Rating Scale (NRS), while physiological stress will be evaluated through heart rate and blood pressure measurements, collected at baseline (T0) and 20 minutes later (T1), immediately after the reduction procedure The trial is designed as a prospective, randomized, controlled study with blinded data analysis, and all data will be collected and managed in compliance with current privacy and data protection regulations. By generating robust evidence on a low-cost, safe, and easily implementable intervention, the PolSound trial aims to improve procedural pain management and patient experience in emergency orthopedic care, potentially supporting the integration of music-based interventions into standard analgesic protocols.
10,054 studies on the registry are indexed under Pain; 1,649 are open to participants now.
This study's planned enrollment of 192 is above the median of 66 across 8,493 interventional studies indexed under Pain.
Browse Pain studies →Azienda Unita Sanitaria Locale di Piacenza is the lead sponsor of 15 studies on the registry; 6 are open to participants now.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
After enrolment and baseline assessment (NRS, heart rate, blood pressure - T0), patients allocated to the intervention groups will receive a 20-minute music session before fracture reduction, followed by reassessment of outcomes at T1 and CRF completion. Group 1 will listen to patient-preferred music via headphones. Music will be administered at the patient's bedside or in the treatment area, ensuring privacy, minimal distractions, and patient comfort.
Other: Music intervention Group 1
After enrolment and baseline assessment (NRS, heart rate, blood pressure - T0), patients allocated to the intervention groups will receive a 20-minute music session before fracture reduction, followed by reassessment of outcomes at T1 and CRF completion. Group 2 will listen to a standardized music playlist selected by a music therapist (instrumental, slow tempo 60-80 BPM, stable dynamics, moderate volume). Music will be administered at the patient's bedside or in the treatment area, ensuring privacy, minimal distractions, and patient comfort.
Other: Music intervention Group 2
The control group will receive standard care without music during the same time interval.
After enrolment and baseline assessment (NRS, heart rate, blood pressure - T0), patients allocated to the intervention groups will receive a 20-minute music session before fracture reduction, followed by reassessment of outcomes at T1 and CRF completion. Group 1 will listen to patient-preferred music via headphones. Music will be administered at the patient's bedside or in the treatment area, ensuring privacy, minimal distractions, and patient comfort.
After enrolment and baseline assessment (NRS, heart rate, blood pressure - T0), patients allocated to the intervention groups will receive a 20-minute music session before fracture reduction, followed by reassessment of outcomes at T1 and CRF completion. Group 2 will listen to a standardized music playlist selected by a music therapist (instrumental, slow tempo 60-80 BPM, stable dynamics, moderate volume). Music will be administered at the patient's bedside or in the treatment area, ensuring privacy, minimal distractions, and patient comfort.
Difference in Numerical Rating Scale (NRS) pain score between T0 and T1
Difference in procedural pain intensity after 20 minutes compared with baseline, evaluated by NRS scores between T0 and T1. The NRS is an 11-point numeric scale ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain intensity. A reduction in NRS score reflects improved pain control.
Time frame: Baseline and 20 minutes after baseline
Plan to share: Undecided
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This study is not yet recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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Azienda Unita Sanitaria Locale di Piacenza