Effects of Music on Procedural Pain in Distal Radius Fracture Reduction

Официальное название

Effects of Music on Pain in Orthopedic Patients With Distal Radius Fractures Undergoing Non-surgical Reduction: a Randomized Controlled Trial

Обзор

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.

Вмешательства

• Другое 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.
• Другое 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 p

Первичные конечные точки

• Difference in Numerical Rating Scale (NRS) pain score between T0 and T1 [Срок оценки: Baseline and 20 minutes after baseline]

Критерии участия

Критерии включения

• 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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Италия · 1 центр

• AUSL of Piacenza — Piacenza

Идентификаторы

NCT: NCT07344883 · PolSound

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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