search
Back to results

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

Primary Purpose

Distal Radius Fracture Reduction

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
No Music
Music
Sponsored by
Corporacion Parc Tauli
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Distal Radius Fracture Reduction

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept 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...).

Sites / Locations

  • Hospital Parc TaulíRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

No Music

Music

Arm Description

Intervention without music

Intervention while listening to music

Outcomes

Primary Outcome Measures

Change in VAS scale for pain
It will be completed after the procedure and the punctuation will go from 0 to 10
Change in Anxiety STAI-6
Puntuation between 20 and 80, 50 considered high anxiety level

Secondary Outcome Measures

Cardiac frequency
Blood pressure
Satisfaction after procedure
1 to 5 scale for satisfaction with the procedure

Full Information

First Posted
July 14, 2023
Last Updated
July 24, 2023
Sponsor
Corporacion Parc Tauli
search

1. Study Identification

Unique Protocol Identification Number
NCT05974384
Brief Title
Music During the Reduction of Distal Radius Fractures as an Adjunctive Therapy for Pain and Anxiety Management.
Official Title
Music During the Reduction of Distal Radius Fractures as an Adjunctive Therapy for Pain and Anxiety Management: A Randomized Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2023 (Actual)
Primary Completion Date
March 1, 2024 (Anticipated)
Study Completion Date
March 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Corporacion Parc Tauli

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Distal Radius Fracture Reduction

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
No Music
Arm Type
Placebo Comparator
Arm Description
Intervention without music
Arm Title
Music
Arm Type
Active Comparator
Arm Description
Intervention while listening to music
Intervention Type
Device
Intervention Name(s)
No Music
Intervention Description
No listening to music while intervention is carried out
Intervention Type
Device
Intervention Name(s)
Music
Intervention Description
Listening to music while intervention is carried out
Primary Outcome Measure Information:
Title
Change in VAS scale for pain
Description
It will be completed after the procedure and the punctuation will go from 0 to 10
Time Frame
Will be completed just after the fracture immobilization
Title
Change in Anxiety STAI-6
Description
Puntuation between 20 and 80, 50 considered high anxiety level
Time Frame
Done just before and after the pfracture immobilization
Secondary Outcome Measure Information:
Title
Cardiac frequency
Time Frame
Will be assessed just before, during and after the fracture imobilization
Title
Blood pressure
Time Frame
Will be assessed just before, during and after the fracture imobilization
Title
Satisfaction after procedure
Description
1 to 5 scale for satisfaction with the procedure
Time Frame
Just after the immobilization, when patient will be discharged

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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...).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Enrique Cueva, Doctor
Phone
937 23 10 10
Ext
21660
Email
enrique.cueva.sevieri@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mireia Viñas, Doctor
Phone
937 23 10 10
Ext
21660
Email
mmvinas@tauli.cat
Facility Information:
Facility Name
Hospital Parc Taulí
City
Sabadell
State/Province
Barcelona
ZIP/Postal Code
08208
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mireia
Phone
21660

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34288886
Citation
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.
Results Reference
background
PubMed Identifier
28920036
Citation
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.
Results Reference
background
PubMed Identifier
27760797
Citation
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.
Results Reference
background
PubMed Identifier
32787892
Citation
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.
Results Reference
background
PubMed Identifier
31413496
Citation
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.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs