Music During the Reduction of Distal Radius Fractures as an Adjunctive Therapy for Pain and Anxiety Management.
Recruiting · NCT05974384 · Interventional (participants receive a specific treatment) · Lead sponsor: Corporacion Parc Tauli
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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...).
Where it is running
1 location listed.
- Hospital Parc Taulí - Sabadell, Barcelona, Spain