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

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.

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Key information

Conditions

Anxiety Anxiety Disorders Femoral Fractures Fractures, Bone Leg Injuries Mental Disorders Music Therapy Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Surgery Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Music intervention

Other

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.

Primary outcomes

Difference between the Amsterdam Preoperative Anxiety and Information Scale (APAIS) at T0 and T1

Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Massimo Guasconi, MSN

CONTACT

[email protected]

+390523303854

Sponsors and collaborators

Lead sponsor

Azienda Unita Sanitaria Locale di Piacenza

Other

Registry information

Official study title

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

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Jun 6, 2025
Registry last updated: Aug 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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