Music During the Reduction of Distal Radius Fractures as an Adjunctive Therapy for Pain and Anxiety Management.

Corporacion Parc Tauli

Status: Enrolling

Conditions: Distal Radius Fracture Reduction

Treatments: Device: No Music; Device: Music

Study type: Interventional

Funder types: Other

Identifiers

NCT05974384

Music Radio

Details and patient eligibility

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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...).

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups, including a placebo group

No Music

Placebo Comparator group

Description:

Intervention without music

Treatment:

Device: No Music

Music

Active Comparator group

Description:

Intervention while listening to music

Treatment:

Device: Music