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

NCT05974384 | Recruiting DMC

• 1 other identifier: Music Radio
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Distal Radius Fracture Reduction

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• 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

Study Arms (2)

No Music

PLACEBO COMPARATOR

Intervention without music

Device: No Music

Music

ACTIVE COMPARATOR

Intervention while listening to music

Device: Music

Interventions

No Music DEVICE

No listening to music while intervention is carried out

No Music

Music DEVICE

Listening to music while intervention is carried out

Music

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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...).

Sponsors & Collaborators

• Corporacion Parc Tauli: lead

Study Sites (1)

Hospital Parc Taulí

Sabadell, Barcelona, 08208, Spain

RECRUITING

Related Publications (5)

• 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.

  PMID: 34288886 BACKGROUND

• 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.

  PMID: 28920036 BACKGROUND

• 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.

  PMID: 27760797 BACKGROUND

• 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.

  PMID: 32787892 BACKGROUND

• 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.

  PMID: 31413496 BACKGROUND

MeSH Terms

Interventions

Music Therapy

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Enrique Cueva, Doctor

CONTACT

937 23 10 10; enrique.cueva.sevieri@gmail.com

Mireia Viñas, Doctor

CONTACT

937 23 10 10; mmvinas@tauli.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: July 14, 2023
• First Posted: August 3, 2023
• Study Start: March 1, 2023
• Primary Completion: November 1, 2024
• Study Completion: March 1, 2025
• Last Updated: August 14, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)