Effects of Music on Procedural Pain in Distal Radius Fracture Reduction

NCT ID: NCT07344883

Last Updated: 2026-01-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 192 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-02-28
• Study Completion Date: 2027-02-28

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group 1-Patient-preferred music

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 Type: EXPERIMENTAL

Music intervention Group 1

Intervention Type: 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 2-Standardized music playlist

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 Type: EXPERIMENTAL

Music intervention Group 2

Intervention Type: 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 3- NO MUSICTHERAPY

The control group will receive standard care without music during the same time interval.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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 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.

Intervention Type: OTHER

Music intervention Group 2

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azienda Unita Sanitaria Locale di Piacenza

OTHER

Sponsor Role: lead

Responsible Party

Massimo Guasconi

RN, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

AUSL of Piacenza

Piacenza, PC, Italy

Countries

Italy

Central Contacts

Massimo Guasconi, MSN, PhD

Role: CONTACT

m.guasconi2@ausl.pc.it

+390523303854

Other Identifiers

PolSound

Identifier Type: -

Identifier Source: org_study_id