An interventional study of No Music and Music in Distal Radius Fracture Reduction, sponsored by Corporacion Parc Tauli. Recruiting at 1 site in Spain. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2024-08-14.
Sponsored by Corporacion Parc Tauli · Not applicable, Interventional, and Supportive care
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.
2,261 studies on the registry are indexed under Fractures, Bone; 325 are open to participants now.
This study's planned enrollment of 100 is above the median of 69 across 1,482 interventional studies indexed under Fractures, Bone.
Browse Fractures, Bone studies →Corporacion Parc Tauli is the lead sponsor of 163 studies on the registry; 25 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Intervention without music
Device: No Music
Intervention while listening to music
Device: Music
No listening to music while intervention is carried out
Listening to music while intervention is carried out
Change in VAS scale for pain
It will be completed after the procedure and the punctuation will go from 0 to 10
Time frame: Will be completed just after the fracture immobilization
Change in Anxiety STAI-6
Puntuation between 20 and 80, 50 considered high anxiety level
Time frame: Done just before and after the pfracture immobilization
Cardiac frequency
Measurement of the cardiac frequency assessed before, during and after fracture immobilization
Time frame: Will be assessed just before, during and after the fracture immobilization
Blood pressure
Measurement of the blood pressure will be assessed before, during and after fracture immobilization
Time frame: Will be assessed just before, during and after the fracture imobilization
Satisfaction after procedure
1 to 5 scale for satisfaction with the procedure
Time frame: Just after the immobilization, when patient will be discharged
Plan to share: No
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Corporacion Parc Tauli