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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Distal Radius Fracture Reduction
• Intervention / Treatment: Device: No Music; Device: Music

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Enrique Cueva, Doctor; Phone Number: 21660 937 23 10 10; Email: enrique.cueva.sevieri@gmail.com
• Study Contact Backup: Name: Mireia Viñas, Doctor; Phone Number: 21660 937 23 10 10; Email: mmvinas@tauli.cat

Study Locations

• Spain
  • Barcelona
    • Sabadell, Barcelona, Spain, 08208
      • Recruiting
      • Hospital Parc Tauli
      • Contact: Mireia; Phone Number: 21660

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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...).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: No Music; Intervention without music	Device: No Music; No listening to music while intervention is carried out
Active Comparator: Music; Intervention while listening to music	Device: Music; Listening to music while intervention is carried out

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in VAS scale for pain	It will be completed after the procedure and the punctuation will go from 0 to 10	Will be completed just after the fracture immobilization
Change in Anxiety STAI-6	Puntuation between 20 and 80, 50 considered high anxiety level	Done just before and after the pfracture immobilization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Satisfaction after procedure	1 to 5 scale for satisfaction with the procedure	Just after the immobilization, when patient will be discharged
Cardiac frequency	Measurement of the cardiac frequency assessed before, during and after fracture immobilization	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	Will be assessed just before, during and after the fracture imobilization

Collaborators and Investigators

• Sponsor: Corporacion Parc Tauli

Publications and helpful links

General Publications

• Chhabra AB, Yildirim B. Adult Distal Radius Fracture Management. J Am Acad Orthop Surg. 2021 Nov 15;29(22):e1105-e1116. doi: 10.5435/JAAOS-D-20-01335.
• Tabrizi A, Mirza Tolouei F, Hassani E, Taleb H, Elmi A. Hematoma Block Versus General Anesthesia in Distal Radius Fractures in Patients Over 60 Years in Trauma Emergency. Anesth Pain Med. 2016 Nov 27;7(1):e40619. doi: 10.5812/aapm.40619. eCollection 2017 Feb.
• Low S, Papay M, Eingartner C. Pain Perception following Initial Closed Reduction in the Preoperative Care of Unstable, Dorsally Displaced Distal Radius Fractures. J Hand Microsurg. 2019 Aug;11(2):111-116. doi: 10.1055/s-0039-1688681. Epub 2019 May 26.
• Lee JH. The Effects of Music on Pain: A Meta-Analysis. J Music Ther. 2016 Winter;53(4):430-477. doi: 10.1093/jmt/thw012. Epub 2016 Oct 19. Erratum In: J Music Ther. 2021 Aug 24;58(3):372. doi: 10.1093/jmt/thab012.
• Sprague S, Scott T, Dodds S, Pogorzelski D, McKay P, Harris AD, Wood A, Thabane L, Bhandari M, Mehta S, Gaski G, Boulton C, Marcano-Fernandez F, Guerra-Farfan E, Hebden J, O'Hara LM, Slobogean GP; PREP-IT Investigators. Cluster identification, selection, and description in cluster randomized crossover trials: the PREP-IT trials. Trials. 2020 Aug 12;21(1):712. doi: 10.1186/s13063-020-04611-9. Erratum In: Trials. 2020 Sep 30;21(1):821. doi: 10.1186/s13063-020-04767-4.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Estimated): November 1, 2024
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: July 14, 2023
• First Submitted That Met QC Criteria: July 24, 2023
• First Posted (Actual): August 3, 2023

Study Record Updates

• Last Update Posted (Actual): August 14, 2024
• Last Update Submitted That Met QC Criteria: August 13, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Arm Injuries; Forearm Injuries; Wrist Injuries; Fractures, Bone; Radius Fractures; Wrist Fractures
• Other Study ID Numbers: Music Radio

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No