AnxietyNCT07008482
Effects of Music on Preoperative Anxiety in Patients With Femoral Fractures Undergoing Surgery
A study testing Music intervention in people with Anxiety and Pain, run by Azienda Unita Sanitaria Locale di Piacenza.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Music intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- No sites listed yet
- Study dates
- Sep 2025to Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients of both sexes, 18 years of age or older
- Patients with femur fracture who are candidates for surgery
- Able to provide informed consent.
Who cannot join
- Patients with a diagnosis of hearing loss
- Patients diagnosed with cognitive or psychiatric disorders
- Patients undergoing emergency/emergency surgery
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effects of Music on Preoperative Anxiety in Patients With Femoral Fractures Scheduled for Surgical Intervention: A Randomized Controlled Study
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
- Being tested
- Music intervention
- Keywords
- NURSING, MUSICTHERAPY, ANXIETY, PAIN
- Medical subject headings
- Anxiety Disorders, Pain, Femoral Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music interventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| MUSIC THERAPY | Experimental | Not described Receives: Other: Music intervention |
| NO MUSICTHERAPY | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 20 minutes after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2025
- Study startSep 2025 (estimated)
- Primary completionJul 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 154 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Unita Sanitaria Locale di Piacenza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Massimo Guasconi, Azienda Unita Sanitaria Locale di Piacenza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07008482
- Sponsor's protocol ID
- SINFEMIA
- Status last verified
- Aug 2025
- First submitted
- 29 May 2025
- Last updated
- 12 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Music on Preoperative Anxiety in Patients With Femoral Fractures Scheduled for Surgical Intervention: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07008482
- Acronym / sponsor ID
- SINFEMIA
- Conditions
- Anxiety, Pain, Surgery, Femoral Fractures, Music Therapy
- Keywords
- NURSING, MUSICTHERAPY, ANXIETY, PAIN
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 154 participants (estimated)
- Lead sponsor
- Azienda Unita Sanitaria Locale di PiacenzaUniversity, hospital or other
- Study start
- Sep 2025 (estimated)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 6 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MUSIC THERAPY | Experimental | Other: Music intervention |
| NO MUSICTHERAPY | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients of both sexes, 18 years of age or older
- Patients with femur fracture who are candidates for surgery
- Able to provide informed consent.
Key exclusion criteria (3 listed)
- Patients with a diagnosis of hearing loss
- Patients diagnosed with cognitive or psychiatric disorders
- Patients undergoing emergency/emergency surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music interventionpatient 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. | Other | MUSIC THERAPY |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Music intervention in people with Anxiety and Pain, run by Azienda Unita Sanitaria Locale di Piacenza.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Massimo Guasconi, MSN (+390523303854, m.guasconi2@ausl.pc.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference between the Amsterdam Preoperative Anxiety and Information Scale (APAIS) at T0 and T1 (time frame: Baseline and 20 minutes after baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2025.