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临床试验/NCT05974384
NCT05974384招募中不适用

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

Corporacion Parc Tauli2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
100
试验地点
2
主要终点
Change in Anxiety STAI-6

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Investigator)

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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...).

结局指标

主要结局

Change in Anxiety STAI-6

时间窗: Done just before and after the pfracture immobilization

Puntuation between 20 and 80, 50 considered high anxiety level

Change in VAS scale for pain

时间窗: Will be completed just after the fracture immobilization

It will be completed after the procedure and the punctuation will go from 0 to 10

次要结局

  • Cardiac frequency(Will be assessed just before, during and after the fracture immobilization)
  • Blood pressure(Will be assessed just before, during and after the fracture imobilization)
  • Satisfaction after procedure(Just after the immobilization, when patient will be discharged)

研究者

发起方
Corporacion Parc Tauli
申办方类型
Other
责任方
Principal Investigator
主要研究者

Heber Enrique Cueva Sevieri

Doctor

Corporacion Parc Tauli

研究点 (2)

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