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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-01

Study Completion Date

2025-03-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Acute Effects of Interferential Current on Edema, Pain and Muscle Strength in Patients With Distal Radius Fracture

NCT03438864

Radius Fractures Edema Pain

COMPLETED NA

PEMF in the Treatment of Fresh Distal Radius Fractures

NCT04287257

Distal Radius Fracture

UNKNOWN NA

Effect of High Frequency Electrical Currents in Healthy Subjects.

NCT02837458

High Frequency Current

COMPLETED NA

Treatment of Lateral Epicondylalgia With Shock Waves

NCT06587412

Epicondylitis of the Elbow Epicondylitis, Lateral

RECRUITING NA

Shock Wave Therapy for Lower Limb Lymphedema

NCT06454734

Lymphedema, Lower Limb

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Distal Radius Fracture Reduction

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

No Music

Intervention without music

Group Type PLACEBO_COMPARATOR

No Music

Intervention Type DEVICE

No listening to music while intervention is carried out

Music

Intervention while listening to music

Group Type ACTIVE_COMPARATOR

Music

Intervention Type DEVICE

Listening to music while intervention is carried out

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

No Music

No listening to music while intervention is carried out

Intervention Type DEVICE

Music

Listening to music while intervention is carried out

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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...).

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No