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Music During the Reduction of Distal Radius Fractures as an Adjunctive Therapy for Pain and Anxiety Management.

Music During the Reduction of Distal Radius Fractures as an Adjunctive Therapy for Pain and Anxiety Management: A Randomized Controlled Clinical Trial

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05974384
Enrollment
100
Registered
2023-08-03
Start date
2023-03-01
Completion date
2025-03-01
Last updated
2024-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Distal Radius Fracture Reduction

Brief summary

Fractures of the distal end of the radius are one of the most frequent fractures diagnosed in the emergency room. The initial management, and in many cases definitive, is carried out through manipulation, closed reduction and immobilization in the emergency room. Different methods of anesthesia have been described to reduce pain during the manipulation and reduction procedure, such as: hematoma block, periosteal block, general anesthesia, intravenous regional anesthesia, nitrous oxide, intramuscular sedation, and conscious sedation. Despite the use of different methods of anesthesia, none is fully effective and each of these methods is not free of complications. Adjuvant measures could play an important role in improving the patient's experience during the procedure, however, there is little evidence in this regard. Music is increasingly being studied and developed as an adjunctive therapy in the management of pain and anxiety in different medical procedures, demonstrating a statistically significant reduction in pain and anxiety. However, in the literature there is no evidence of studies that evaluate the effect of music during the reduction of fractures in traumatology as an adjuvant therapy for the management of pain and anxiety. In our experience, despite the anesthesia used, reductions of distal radius fractures are usually a painful procedure that involves a certain degree of discomfort for the patient. For this reason, the investigators believe this study is necessary, as it could demonstrate a new adjuvant therapy that reduces pain and anxiety and improves the overall experience of the patient, in addition to being music, a low-cost tool with no risks for patient safety.

Interventions

DEVICENo Music

No listening to music while intervention is carried out

DEVICEMusic

Listening to music while intervention is carried out

Sponsors

Corporacion Parc Tauli
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

Inclusion criteria

* Patients older than 18 years. * Clinical and radiological diagnosis of a fracture of the distal end of a closed radius that has an indication for closed reduction.

Exclusion criteria

* Diagnosis of other concomitant fractures. * Allergy to local anesthetics. * Significant hearing impairment and/or use of hearing aids. * Patients whose comorbidities prevent correct participation in the procedure (such as cognitive impairment, diagnosis of psychiatric diseases, patients under the influence of drugs...).

Design outcomes

Primary

MeasureTime frameDescription
Change in VAS scale for painWill be completed just after the fracture immobilizationIt will be completed after the procedure and the punctuation will go from 0 to 10
Change in Anxiety STAI-6Done just before and after the pfracture immobilizationPuntuation between 20 and 80, 50 considered high anxiety level

Secondary

MeasureTime frameDescription
Cardiac frequencyWill be assessed just before, during and after the fracture immobilizationMeasurement of the cardiac frequency assessed before, during and after fracture immobilization
Blood pressureWill be assessed just before, during and after the fracture imobilizationMeasurement of the blood pressure will be assessed before, during and after fracture immobilization
Satisfaction after procedureJust after the immobilization, when patient will be discharged1 to 5 scale for satisfaction with the procedure

Countries

Spain

Contacts

Primary ContactEnrique Cueva, Doctor
enrique.cueva.sevieri@gmail.com937 23 10 10
Backup ContactMireia Viñas, Doctor
mmvinas@tauli.cat937 23 10 10

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026