Effects of Music on Procedural Pain in Distal Radius Fracture Reduction

NCT07344883 | Not Yet Recruiting

• 1 other identifier: PolSound
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

nursing; musictherapy; pain

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and 20 minutes after baseline

Study Arms (3)

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.

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.

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.

Interventions

Music intervention Group 2 OTHER

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.

Group 2-Standardized music playlist

Music intervention Group 1 OTHER

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.

Group 1-Patient-preferred music

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients with severe hearing impairment
• Patients diagnosed with cognitive or psychiatric disorders
• Patients requiring emergency/urgent intervention
• Open fractures (exposed fractures)

Sponsors & Collaborators

• Azienda Unita Sanitaria Locale di Piacenza: lead

Study Sites (1)

AUSL of Piacenza

Piacenza, PC, 29122, Italy

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Massimo Guasconi, MSN, PhD

CONTACT

+390523303854; m.guasconi2@ausl.pc.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Data processing will be blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: RN, PhD

Study Record Dates

• First Submitted: January 8, 2026
• First Posted: January 15, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: January 15, 2026

Record last verified: 2026-01

Locations

IT (1)