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

Not Applicable

Not yet recruiting

• Conditions: Anxiety; Surgery; Femoral Fractures; Pain; Music Therapy

• Registration Number: NCT07008482
• Lead Sponsor: Azienda Unita Sanitaria Locale di Piacenza

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-05-29
• Study First Submitted QC: 2025-05-29
• Study First Posted: 2025-06-06
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-11
• Last Update Posted: 2025-08-12
• Study Start: 2025-09-01
• Primary Completion: 2026-07
• Study Completion: 2026-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 154

Inclusion Criteria

• Patients of both sexes, 18 years of age or older
• Patients with femur fracture who are candidates for surgery
• Able to provide informed consent.

Exclusion Criteria

• Patients with a diagnosis of hearing loss
• Patients diagnosed with cognitive or psychiatric disorders
• Patients undergoing emergency/emergency surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Difference between the Amsterdam Preoperative Anxiety and Information Scale (APAIS) at T0 and T1	Baseline and 20 minutes after baseline	Difference in preoperative anxiety level after 20 minutes and baseline evaluated by APAIS scores between T0 and T1. The APAIS consists of six questions, with each question rated on a 5-point Likert scale (1=not at all, 5=extremely), and has a minimum score of 6 and a maximum score of 30. Higher APAIS scores indicate a worse outcome with higher levels of anxiety and a greater desire for information.