Lower Extremity FractureADTPPNCT05927480
Audio Distraction for Traction Pin Placement
A study testing Audio distraction in people with Lower Extremity Fracture, run by HealthPartners Institute at 2 sites in United States.
Trial summary
Traction pin placement is a common way to temporarily manage femur fractures and unstable acetabular fractures while awaiting surgery. Skeletal traction is thought to reduce patient discomfort by improving fracture alignment as well as relaxing muscle spasm pain felt from the broken bone by stretching out the leg. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lower Extremity Fracture
- What is being tested?
- Audio distraction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 2 sitesUnited States
- Study dates
- 25 Apr 2018to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Conscious, oriented, able to give informed consent
- Medical need for distal femoral or proximal tibial skeletal traction pin placement
Who cannot join
- Medical contraindication to skeletal traction
- Endotracheal intubation
- Unable to participate in verbal communication throughout the procedure and in the recovery phase
- Sensory impairment to pain
- Inability to make accurate mark on VAS 2/2 cognitive, motor or visual deficiencies.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Jackson Memorial Hospital
Miami, Florida, 33136
Regions Hospital
Saint Paul, Minnesota, 55101
About this study
Official title: Audio Distraction for Traction Pin Placement: A Randomized Controlled Trial
Traction pin placement is a common way to temporarily manage femur fractures and unstable acetabular fractures while awaiting surgery. Skeletal traction is thought to reduce patient discomfort by improving fracture alignment as well as relaxing muscle spasm pain felt from the broken bone by stretching out the leg. Skeletal traction may also help prevent articular surface damage in the hip by decreasing joint pressure. Despite the benefits of skeletal traction, insertion of the traction pin can be a painful and unpleasant experience for the patient. Our study hopes to see if listening to music with headphones during insertion of the traction pin decrease patient pain and anxiety.
Read the detailed description
Given that skeletal traction is the current standard of care at our institution; our study will focus on the use of audio distraction during placement of skeletal traction and the effect on patient discomfort. There have been multiple studies examining the use of various distraction techniques for pain and anxiety, mainly with patients undergoing GI procedures, such as colonoscopy. The goal of our study is to investigate the use audio distraction with music from an mp3 player and headphones, and the effect on patient anxiety and pain during the placement of a skeletal traction pin. Provider-perceived patient cooperation and procedure difficulty will also be assessed.
This is a prospective randomized controlled trial at Regions Hospital in Saint Paul, MN and Jackson Memorial Hospital in Miami, Florida to compare primary outcomes of subjects between audio distraction and no audio distraction groups during traction pin placement. Recruitment of patients for inclusion in this study will be completed by the orthopedic resident placing the skeletal traction pin. Patients will be recruited for inclusion in this study after determining the medical need for placement of a skeletal traction pin. Routine care will be provided by the orthopedic resident for skeletal traction pin placement. Those included in this study and randomized into the treatment arm will be given an mp3 device and headphones to listen to a genre of music of their choosing in addition to being treated to the current routine care. Those randomized into the control arm will be treated to the current routine care without any use of music. Patients will be randomized into 2 groups; audio distraction with music versus control group with no music.
- Conditions
- Lower Extremity Fracture
- Being tested
- Audio distraction
- Keywords
- Skeletal Traction, Audio Distraction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Audio distractionBehavioural
Music on an mp3 player will be provided to the patient for them to listen to while having the traction pin placed.
| Study group | Role | What they receive |
|---|---|---|
| Audio Distraction | Experimental | Those included in this study and randomized into the treatment arm will be given an mp3 device and headphones to listen to genre of music of their choosing in addition to be treated to the routine care with the skeletal traction pin. Receives: Behavioral: Audio distraction |
| Control | No intervention | Those randomized into this arm will receive the current routine care which is treatment with a skeletal traction pin and no audio distraction. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-reported Pain
A 10-point visual analog scale for pain with 1 being the best possible outcome and 10 being the worst possible outcome. Scale is from 1-10.
Measured: Immediately after the procedure
Patient-reported Anxiety
A 10-point visual analog scale for anxiety with 1 being the best possible outcome and 10 being the worst possible outcome. Scale is from 1-10.
Measured: Immediately after the procedure
Patient-reported Overall Experience
A 10-point visual analog scale for patient's reported overall experience with 1 being the best possible outcome and 10 being the worst possible outcome. Scale is from 1-10.
Measured: Immediately after the procedure
Secondary outcomes (2)
Procedure Time
Overall time required for placement of skeletal traction pin
Measured: Obtained by resident from start of lidocaine injection to end of procedure (disconnecting the drill) (up to 60 minutes).
Physician Reported Procedure Difficulty
Resident physician will fill out survey after the procedure to evaluate the difficulty of the procedure on a 1-10 scale (1 - easy to 10- most difficult).
Measured: Immediately after the procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start25 Apr 2018
- Primary completion19 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Lower Extremity FractureStudies 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
- Model description
- There are two treatment arms. Each undergo traction pin placement, but one arm is provided headphones with music while the other is not offered anything.
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- HealthPartners Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Jackson Health System
- Responsible party
- Sponsor
- Investigators
- Brian P Cunningham, Principal investigator, brian.cunningham@parknicollet.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05927480
- Sponsor's protocol ID
- A17-285
- Acronym
- ADTPP
- Status last verified
- May 2023
- First submitted
- 6 Jun 2023
- Last updated
- 3 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: In order to secure patient confidentiality and data security, all data will be de-identified. All patients will be assigned a research identification number (not their MRN) that cannot be associated with their name, birthdate, or other identifying information. Patient information will only be accessed via secure servers for Regions Hospital and on encrypted password-protected computers. If it is necessary to transmit patient data, it will be transmitted in the de-identified format, using only patient research identification numbers. At the end of the study, the electronic files will be permanently deleted and patient identifiers will be removed. All hard copies will be shredded.
Publications
DeFroda SF, Gil JA, Born CT. Indications and anatomic landmarks for the application of lower extremity traction: a review. Eur J Trauma Emerg Surg. 2016 Dec;42(6):695-700. doi: 10.1007/s00068-016-0712-3. Epub 2016 Jul 23.
PubMed 27448398Resch S, Thorngren KG. Preoperative traction for hip fracture: a randomized comparison between skin and skeletal traction in 78 patients. Acta Orthop Scand. 1998 Jun;69(3):277-9. doi: 10.3109/17453679809000929.
PubMed 9703402Bampton P, Draper B. Effect of relaxation music on patient tolerance of gastrointestinal endoscopic procedures. J Clin Gastroenterol. 1997 Jul;25(1):343-5. doi: 10.1097/00004836-199707000-00010.
PubMed 9412917Bechtold ML, Perez RA, Puli SR, Marshall JB. Effect of music on patients undergoing outpatient colonoscopy. World J Gastroenterol. 2006 Dec 7;12(45):7309-12. doi: 10.3748/wjg.v12.i45.7309.
PubMed 17143946Palakanis KC, DeNobile JW, Sweeney WB, Blankenship CL. Effect of music therapy on state anxiety in patients undergoing flexible sigmoidoscopy. Dis Colon Rectum. 1994 May;37(5):478-81. doi: 10.1007/BF02076195.
PubMed 8181411Hornblow AR, Kidson MA. The visual analogue scale for anxiety: a validation study. Aust N Z J Psychiatry. 1976 Dec;10(4):339-41. doi: 10.3109/00048677609159523. No abstract available.
PubMed 1071419Todd KH, Funk KG, Funk JP, Bonacci R. Clinical significance of reported changes in pain severity. Ann Emerg Med. 1996 Apr;27(4):485-9. doi: 10.1016/s0196-0644(96)70238-x.
PubMed 8604867Singer AJ, Thode HC Jr. Determination of the minimal clinically significant difference on a patient visual analog satisfaction scale. Acad Emerg Med. 1998 Oct;5(10):1007-11. doi: 10.1111/j.1553-2712.1998.tb02781.x.
PubMed 9862594
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Audio Distraction for Traction Pin Placement: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05927480
- Acronym / sponsor ID
- ADTPP / A17-285
- Conditions
- Lower Extremity Fracture
- Keywords
- Skeletal Traction, Audio Distraction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- HealthPartners InstituteUniversity, hospital or other
- Collaborators
- Jackson Health System
- Study start
- 25 Apr 2018 (actual)
- Primary completion
- 19 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 3 Jul 2023 (actual)
- Results
- Posted 3 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Traction pin placement is a common way to temporarily manage femur fractures and unstable acetabular fractures while awaiting surgery. Skeletal traction is thought to reduce patient discomfort by improving fracture alignment as well as relaxing muscle spasm pain felt from the broken bone by stretching out the leg. Skeletal traction may also help prevent articular surface damage in the hip by decreasing joint pressure. Despite the benefits of skeletal traction, insertion of the traction pin can be a painful and unpleasant experience for the patient. Our study hopes to see if listening to music with headphones during insertion of the traction pin decrease patient pain and anxiety.
Detailed description
Given that skeletal traction is the current standard of care at our institution; our study will focus on the use of audio distraction during placement of skeletal traction and the effect on patient discomfort. There have been multiple studies examining the use of various distraction techniques for pain and anxiety, mainly with patients undergoing GI procedures, such as colonoscopy. The goal of our study is to investigate the use audio distraction with music from an mp3 player and headphones, and the effect on patient anxiety and pain during the placement of a skeletal traction pin. Provider-perceived patient cooperation and procedure difficulty will also be assessed.
This is a prospective randomized controlled trial at Regions Hospital in Saint Paul, MN and Jackson Memorial Hospital in Miami, Florida to compare primary outcomes of subjects between audio distraction and no audio distraction groups during traction pin placement. Recruitment of patients for inclusion in this study will be completed by the orthopedic resident placing the skeletal traction pin. Patients will be recruited for inclusion in this study after determining the medical need for placement of a skeletal traction pin. Routine care will be provided by the orthopedic resident for skeletal traction pin placement. Those included in this study and randomized into the treatment arm will be given an mp3 device and headphones to listen to a genre of music of their choosing in addition to being treated to the current routine care. Those randomized into the control arm will be treated to the current routine care without any use of music. Patients will be randomized into 2 groups; audio distraction with music versus control group with no music.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- There are two treatment arms. Each undergo traction pin placement, but one arm is provided headphones with music while the other is not offered anything.
| Arm | Type | Receives |
|---|---|---|
| Audio Distraction | Experimental | Behavioral: Audio distractionThose included in this study and randomized into the treatment arm will be given an mp3 device and headphones to listen to genre of music of their choosing in addition to be treated to the routine care with the skeletal traction pin. |
| Control | No intervention | –Those randomized into this arm will receive the current routine care which is treatment with a skeletal traction pin and no audio distraction. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Conscious, oriented, able to give informed consent
- Medical need for distal femoral or proximal tibial skeletal traction pin placement
Key exclusion criteria (5 listed)
- Medical contraindication to skeletal traction
- Endotracheal intubation
- Unable to participate in verbal communication throughout the procedure and in the recovery phase
- Sensory impairment to pain
- Inability to make accurate mark on VAS 2/2 cognitive, motor or visual deficiencies.
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 |
|---|---|---|
| Audio distractionMusic on an mp3 player will be provided to the patient for them to listen to while having the traction pin placed. | Behavioural | Audio Distraction |
Primary outcome
Patient-reported Pain
Time frame: Immediately after the procedure
A 10-point visual analog scale for pain with 1 being the best possible outcome and 10 being the worst possible outcome. Scale is from 1-10.
Patient-reported Anxiety
Time frame: Immediately after the procedure
A 10-point visual analog scale for anxiety with 1 being the best possible outcome and 10 being the worst possible outcome. Scale is from 1-10.
Patient-reported Overall Experience
Time frame: Immediately after the procedure
A 10-point visual analog scale for patient's reported overall experience with 1 being the best possible outcome and 10 being the worst possible outcome. Scale is from 1-10.
2 secondary outcomes
Procedure Time
Time frame: Obtained by resident from start of lidocaine injection to end of procedure (disconnecting the drill) (up to 60 minutes).
Physician Reported Procedure Difficulty
Time frame: Immediately after the procedure.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 27448398DeFroda SF, Gil JA, Born CT. Indications and anatomic landmarks for the application of lower extremity traction: a review. Eur J Trauma Emerg Surg. 2016 Dec;42(6):695-700. doi: 10.1007/s00068-016-0712-3. Epub 2016 Jul 23.
- Background: PubMed 9703402Resch S, Thorngren KG. Preoperative traction for hip fracture: a randomized comparison between skin and skeletal traction in 78 patients. Acta Orthop Scand. 1998 Jun;69(3):277-9. doi: 10.3109/17453679809000929.
- Background: PubMed 9412917Bampton P, Draper B. Effect of relaxation music on patient tolerance of gastrointestinal endoscopic procedures. J Clin Gastroenterol. 1997 Jul;25(1):343-5. doi: 10.1097/00004836-199707000-00010.
- Background: PubMed 17143946Bechtold ML, Perez RA, Puli SR, Marshall JB. Effect of music on patients undergoing outpatient colonoscopy. World J Gastroenterol. 2006 Dec 7;12(45):7309-12. doi: 10.3748/wjg.v12.i45.7309.
- Background: PubMed 8181411Palakanis KC, DeNobile JW, Sweeney WB, Blankenship CL. Effect of music therapy on state anxiety in patients undergoing flexible sigmoidoscopy. Dis Colon Rectum. 1994 May;37(5):478-81. doi: 10.1007/BF02076195.
- Background: PubMed 1071419Hornblow AR, Kidson MA. The visual analogue scale for anxiety: a validation study. Aust N Z J Psychiatry. 1976 Dec;10(4):339-41. doi: 10.3109/00048677609159523. No abstract available.
- Background: PubMed 8604867Todd KH, Funk KG, Funk JP, Bonacci R. Clinical significance of reported changes in pain severity. Ann Emerg Med. 1996 Apr;27(4):485-9. doi: 10.1016/s0196-0644(96)70238-x.
- Background: PubMed 9862594Singer AJ, Thode HC Jr. Determination of the minimal clinically significant difference on a patient visual analog satisfaction scale. Acad Emerg Med. 1998 Oct;5(10):1007-11. doi: 10.1111/j.1553-2712.1998.tb02781.x.
- Individual participant dataSharing planned: No. In order to secure patient confidentiality and data security, all data will be de-identified. All patients will be assigned a research identification number (not their MRN) that cannot be associated with their name, birthdate, or other identifying information. Patient information will only be accessed via secure servers for Regions Hospital and on encrypted password-protected computers. If it is necessary to transmit patient data, it will be transmitted in the de-identified format, using only patient research identification numbers. At the end of the study, the electronic files will be permanently deleted and patient identifiers will be removed. All hard copies will be shredded.
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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.
Brian P Cunningham principal investigator
brian.cunningham@parknicollet.com
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Audio distraction in people with Lower Extremity Fracture, run by HealthPartners Institute at 2 sites in United States.
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 5 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 3 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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. 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?
Yes. Results are posted in the registry (first posted 3 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Patient-reported Pain (time frame: Immediately after the procedure). The study lists 3 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 NCT05927480, which also lists 8 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 3 Dec 2024.