RecruitingNot ApplicableNCT05974384

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


Sponsor

Corporacion Parc Tauli

Enrollment

100 participants

Start Date

Mar 1, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether listening to music during the procedure to reset a broken wrist (closed reduction) helps reduce pain and anxiety. Patients are randomly assigned to listen to music or not during the procedure. **You may be eligible if...** - You are 18 or older - You have been diagnosed with a broken wrist (distal radius fracture) that needs to be physically repositioned (reduced) without surgery **You may NOT be eligible if...** - You have other fractures at the same time - You have an allergy to local anesthetics - You have significant hearing impairment or use hearing aids - You have cognitive impairment, a psychiatric diagnosis, or are under the influence of substances that would prevent proper participation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICENo Music

No listening to music while intervention is carried out

DEVICEMusic

Listening to music while intervention is carried out


Locations(1)

Hospital Parc Taulí

Sabadell, Barcelona, Spain

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NCT05974384


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