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

NCT ID: NCT07008482

Last Updated: 2025-08-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

154 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-30

Study Completion Date

2026-07-31

Brief Summary

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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

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Conditions

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Anxiety Pain Surgery Femoral Fractures Music Therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators
Data processing will be blinded

Study Groups

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MUSIC THERAPY

Group Type EXPERIMENTAL

Music intervention

Intervention Type 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.

NO MUSICTHERAPY

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Azienda Unita Sanitaria Locale di Piacenza

OTHER

Sponsor Role lead

Responsible Party

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Massimo Guasconi

RN, MSN

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Massimo Guasconi, MSN

Role: CONTACT

+390523303854

Other Identifiers

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SINFEMIA

Identifier Type: -

Identifier Source: org_study_id

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