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

Study Overview
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Brief Summary
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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.

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

Conditions
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Distal Radius Fracture Reduction

Intervention / Treatment
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* Device: No Music
* Device: Music


Participation Criteria
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Eligibility Criteria
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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...).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: No Music<br>Intervention without music | Device: No Music<br>* No listening to music while intervention is carried out<br>|
| Active Comparator: Music<br>Intervention while listening to music | Device: Music<br>* Listening to music while intervention is carried out<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in VAS scale for pain | It will be completed after the procedure and the punctuation will go from 0 to 10 | Will be completed just after the fracture immobilization | 
| Change in Anxiety STAI-6 | Puntuation between 20 and 80, 50 considered high anxiety level | Done just before and after the pfracture immobilization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac frequency |  | Will be assessed just before, during and after the fracture imobilization | 
| Blood pressure |  | Will be assessed just before, during and after the fracture imobilization | 
| Satisfaction after procedure | 1 to 5 scale for satisfaction with the procedure | Just after the immobilization, when patient will be discharged |