NCT07008482

Effects of Music on Preoperative Anxiety in Patients With Femoral Fractures Undergoing Surgery

Effects of Music on Preoperative Anxiety in Patients With Femoral Fractures Scheduled for Surgical Intervention: A Randomized Controlled Study

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 154 (estimated)
• Sponsor: Azienda Unita Sanitaria Locale di Piacenza · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This randomized controlled trial (RCT) investigates the effectiveness of music therapy in reducing preoperative anxiety among elderly patients with femoral fractures. Preoperative anxiety is known to worsen physiological stability, increase pain perception, and negatively impact recovery, yet specific evidence on non-pharmacological interventions like music therapy in the orthogeriatric setting is lacking. The study will enroll 154 adult patients admitted to the Orthogeriatrics Unit for elective femoral fracture surgery. Participants will be randomly assigned to receive either a 20-minute session of music therapy or standard care. Anxiety will be measured using the APAIS scale, and pain will be assessed with the NRS scale, both before and after the intervention. The trial is designed as a blinded, prospective RCT, with data collected and managed under current privacy regulations. By generating robust data on this low-cost, safe intervention, the study aims to improve preoperative management and patient outcomes in orthopedic surgical care.

Conditions

• Anxiety
• Pain
• Surgery
• Femoral Fractures
• Music Therapy

Interventions

Type	Name	Description
OTHER	Music intervention	patient enrolment, administration of the APAIS and NRS scales (T0), administration of the standard music therapy/assistance intervention (20 minutes duration), re-evaluation with re-administration of the APAIS and NRS scales (T1) and completion of the CRF. The administration will take place at the patient's bedside, respecting the privacy and confidentiality of the subjects involved, guaranteeing absolute tranquillity, also with the help of dividers to avoid distractions and interruptions.

Timeline

• Start date: 2025-09-01
• Primary completion: 2026-07-01
• Completion: 2026-07-01
• First posted: 2025-06-06
• Last updated: 2025-08-12