NCT05974384 Music During the Reduction of Distal Radius Fractures as an Adjunctive Therapy for Pain and Anxiety Management.
| NCT ID | NCT05974384 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Corporacion Parc Tauli |
| Condition | Distal Radius Fracture Reduction |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2023-03-01 |
| Primary Completion | 2024-11-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2023-03-01 with a primary completion date of 2024-11-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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...).
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05974384 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 100 Years, studying Distal Radius Fracture Reduction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05974384 currently recruiting?
Yes, NCT05974384 is actively recruiting participants. Contact the research team at enrique.cueva.sevieri@gmail.com for enrollment information.
Where is the NCT05974384 trial being conducted?
This trial is being conducted at Sabadell, Spain.
Who is sponsoring the NCT05974384 clinical trial?
NCT05974384 is sponsored by Corporacion Parc Tauli. The trial plans to enroll 100 participants.