PainNCT07344883
Effects of Music on Procedural Pain in Distal Radius Fracture Reduction
A study testing Music intervention Group 1 and Music intervention Group 2 in people with Pain and Blood Pressure, run by Azienda Unita Sanitaria Locale di Piacenza at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Blood Pressure, Heart Rate
- What is being tested?
- Music intervention Group 1 and Music intervention Group 2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 1 siteItaly
- Study dates
- Feb 2026to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients of both sexes, 18 years of age or older
- Patients with distal radius fracture requiring non-surgical (closed) reduction
- Able to provide informed consent
Who cannot join
- Patients with severe hearing impairment
- Patients diagnosed with cognitive or psychiatric disorders
- Patients requiring emergency/urgent intervention
- Open fractures (exposed fractures)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effects of Music on Pain in Orthopedic Patients With Distal Radius Fractures Undergoing Non-surgical Reduction: a Randomized Controlled Trial
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.
- Conditions
- Pain, Blood Pressure, Heart Rate, Music Therapy, Nursing
- Being tested
- Music intervention Group 1, Music intervention Group 2
- Keywords
- nursing, musictherapy, pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music intervention Group 1Other
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.
Music intervention Group 2Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1-Patient-preferred music | Experimental | 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. Receives: Other: Music intervention Group 1 |
| Group 2-Standardized music playlist | Experimental | 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. Receives: Other: Music intervention Group 2 |
| Group 3- NO MUSICTHERAPY | No intervention | The control group will receive standard care without music during the same time interval. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 20 minutes after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study startFeb 2026 (estimated)
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 192 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Unita Sanitaria Locale di Piacenza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Massimo Guasconi, Azienda Unita Sanitaria Locale di Piacenza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07344883
- Sponsor's protocol ID
- PolSound
- Status last verified
- Jan 2026
- First submitted
- 8 Jan 2026
- Last updated
- 15 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Music on Pain in Orthopedic Patients With Distal Radius Fractures Undergoing Non-surgical Reduction: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07344883
- Acronym / sponsor ID
- PolSound
- Conditions
- Pain, Blood Pressure, Heart Rate, Music Therapy, Nursing
- Keywords
- nursing, musictherapy, pain
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 192 participants (estimated)
- Lead sponsor
- Azienda Unita Sanitaria Locale di PiacenzaUniversity, hospital or other
- Study start
- Feb 2026 (estimated)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 15 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1-Patient-preferred music | Experimental | Other: Music intervention Group 1After 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. |
| Group 2-Standardized music playlist | Experimental | Other: Music intervention Group 2After 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. |
| Group 3- NO MUSICTHERAPY | No intervention | –The control group will receive standard care without music during the same time interval. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients of both sexes, 18 years of age or older
- Patients with distal radius fracture requiring non-surgical (closed) reduction
- Able to provide informed consent
Key exclusion criteria (4 listed)
- Patients with severe hearing impairment
- Patients diagnosed with cognitive or psychiatric disorders
- Patients requiring emergency/urgent intervention
- Open fractures (exposed fractures)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music intervention Group 1After 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 | Group 1-Patient-preferred music |
| Music intervention Group 2After 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 | Group 2-Standardized music playlist |
Primary outcome
Difference in Numerical Rating Scale (NRS) pain score between T0 and T1
Time frame: Baseline and 20 minutes after baseline
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music intervention Group 1 and Music intervention Group 2 in people with Pain and Blood Pressure, run by Azienda Unita Sanitaria Locale di Piacenza at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Massimo Guasconi, MSN, PhD (+390523303854, m.guasconi2@ausl.pc.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in Numerical Rating Scale (NRS) pain score between T0 and T1 (time frame: Baseline and 20 minutes after baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026.