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

NCT07008482 | Not Yet Recruiting

• 1 other identifier: SINFEMIA
• Study Type: interventional
• Target: 154
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Anxiety; Pain; Surgery; Femoral Fractures; Music Therapy

Keywords

NURSING; MUSICTHERAPY; ANXIETY; PAIN

Outcome Measures

Primary Outcomes (1)

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

  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.

  Baseline and 20 minutes after baseline

Study Arms (2)

MUSIC THERAPY

EXPERIMENTAL

Other: Music intervention

NO MUSICTHERAPY

NO INTERVENTION

Interventions

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.

MUSIC THERAPY

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Azienda Unita Sanitaria Locale di Piacenza: lead

MeSH Terms

Conditions

Anxiety Disorders; Pain; Femoral Fractures

Condition Hierarchy (Ancestors)

Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Fractures, Bone; Wounds and Injuries; Leg Injuries

Central Study Contacts

Massimo Guasconi, MSN

CONTACT

+390523303854; m.guasconi2@ausl.pc.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Data processing will be blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: RN, MSN

Study Record Dates

• First Submitted: May 29, 2025
• First Posted: June 6, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: August 12, 2025

Record last verified: 2025-08