Distal Radius Fracture ReductionNCT05974384
Music During the Reduction of Distal Radius Fractures as an Adjunctive Therapy for Pain and Anxiety Management.
A study testing No Music and Music in people with Distal Radius Fracture Reduction, run by Corporacion Parc Tauli at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Distal Radius Fracture Reduction
- What is being tested?
- No Music and Music
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2023to 4 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Distal Radius Fracture Reduction
- Being tested
- No Music, Music
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No MusicDevice
No listening to music while intervention is carried out
MusicDevice
Listening to music while intervention is carried out
| Study group | Role | What they receive |
|---|---|---|
| No Music | Placebo comparator | Intervention without music Receives: Device: No Music |
| Music | Active comparator | Intervention while listening to music Receives: Device: Music |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in VAS scale for pain
It will be completed after the procedure and the punctuation will go from 0 to 10
Measured: Will be completed just after the fracture immobilization
Change in Anxiety STAI-6
Puntuation between 20 and 80, 50 considered high anxiety level
Measured: Done just before and after the pfracture immobilization
Secondary outcomes (3)
Cardiac frequency
Measurement of the cardiac frequency assessed before, during and after fracture immobilization
Measured: 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
Measured: Will be assessed just before, during and after the fracture imobilization
Satisfaction after procedure
1 to 5 scale for satisfaction with the procedure
Measured: Just after the immobilization, when patient will be discharged
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2023
- Study start1 Mar 2023
- Primary completion4 Feb 2025
- Study completion4 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Distal Radius Fracture ReductionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corporacion Parc Tauli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heber Enrique Cueva Sevieri, Corporacion Parc Tauli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05974384
- Sponsor's protocol ID
- Music Radio
- Status last verified
- Aug 2024
- First submitted
- 14 Jul 2023
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 34288886Tabrizi 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.
PubMed 28920036Lee 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.
PubMed 27760797Sprague 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.
PubMed 32787892Low 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.
PubMed 31413496
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Music During the Reduction of Distal Radius Fractures as an Adjunctive Therapy for Pain and Anxiety Management: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05974384
- Acronym / sponsor ID
- Music Radio
- Conditions
- Distal Radius Fracture Reduction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Corporacion Parc TauliUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 4 Feb 2025 (actual)
- Study completion
- 4 Feb 2025 (actual)
- First posted
- 3 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No Music | Placebo comparator | Device: No MusicIntervention without music |
| Music | Active comparator | Device: MusicIntervention while listening to music |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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...).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No MusicNo listening to music while intervention is carried out | Device | No Music |
| MusicListening to music while intervention is carried out | Device | Music |
Primary outcome
Change in VAS scale for pain
Time frame: Will be completed just after the fracture immobilization
It will be completed after the procedure and the punctuation will go from 0 to 10
Change in Anxiety STAI-6
Time frame: Done just before and after the pfracture immobilization
Puntuation between 20 and 80, 50 considered high anxiety level
3 secondary outcomes
Cardiac frequency
Time frame: Will be assessed just before, during and after the fracture immobilization
Blood pressure
Time frame: Will be assessed just before, during and after the fracture imobilization
Satisfaction after procedure
Time frame: Just after the immobilization, when patient will be discharged
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- Background: PubMed 34288886Chhabra 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.
- Background: PubMed 28920036Tabrizi 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.
- Background: PubMed 27760797Lee 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.
- Background: PubMed 32787892Sprague 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.
- Background: PubMed 31413496Low 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.
- Individual participant dataSharing planned: No
Related trials for Distal Radius Fracture Reduction
Recruiting
No Reduction Compared to Closed Reduction for Distal Radius Fractures in Patients Over 65 or Older
Distal Radius Fracture, Casting
RecruitingPhase 1
Impact of Early ADL Education on Outcomes Post DRF ORIF
Distal Radius Fractures
Active, not recruitingPhase 4
Brachial Plexus Nerve Block Versus Haematoma Block for Closed Reduction of Distal Radius Fracture in Adults - The BLOCK Trial. A Multicentre Randomised Controlled Trial.
Distal Radius Fractures, Fracture Dislocation
RecruitingPhase 4
A Clinical Trial on the Use of Lidocaine Infusion During Surgery for Pediatric Upper Extremity Fractures and Its Impact on Total Perioperative Opioid Requirements
Fracture Arm, Fracture Closed of Lower End of Forearm, Unspecified
Recruiting
Distal Radius Interventions for Fracture Treatment
Fracture Distal Radius
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing No Music and Music in people with Distal Radius Fracture Reduction, run by Corporacion Parc Tauli at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in VAS scale for pain (time frame: Will be completed just after the fracture immobilization). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05974384, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026.