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| Name | Class |
|---|---|
| Jackson Health System | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Audio distraction | Behavioral | Music on an mp3 player will be provided to the patient for them to listen to while having the traction pin placed. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | Immediately after the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Procedure Time | Overall time required for placement of skeletal traction pin | Obtained by resident from start of lidocaine injection to end of procedure (disconnecting the drill) (up to 60 minutes). |
| Physician Reported Procedure Difficulty |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brian P Cunningham | brian.cunningham@parknicollet.com | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jackson Memorial Hospital | Miami | Florida | 33136 | United States | ||
| Regions Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27448398 | Background | 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. | |
| 9703402 | Background | Resch 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. |
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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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Of the 54 enrolled participants, all 54 met inclusion criteria and were randomized into the two arms of the study.
A prospective randomized controlled trial was conducted to from 2018-2022 at two level-I trauma centers across North America.
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| ID | Title | Description |
|---|---|---|
| FG000 | Audio Distraction | 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. Audio distraction: Music on an mp3 player will be provided to the patient for them to listen to while having the traction pin placed. |
| FG001 | Control | Those randomized into this arm will receive the current routine care which is treatment with a skeletal traction pin and no audio distraction. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Audio Distraction | 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. Audio distraction: Music on an mp3 player will be provided to the patient for them to listen to while having the traction pin placed. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | units on a scale | Immediately after the procedure |
|
Use of in-ear headphones for listening to music during the application of the traction pin which was approximately a 1-hour time frame.
Only participants in the audio distraction arm who used the in-ear headphones were at risk.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Audio Distraction | 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. Audio distraction: Music on an mp3 player will be provided to the patient for them to listen to while having the traction pin placed. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sandy Vang, Director of Research Administration at Regions Hospital | HealthPartners Institute | 1-651-254-6961 | sandy.x.vang@healthpartners.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 22, 2017 | Mar 27, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 20, 2018 | Mar 27, 2024 | ICF_001.pdf |
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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.
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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).
| Immediately after the procedure. |
| Saint Paul |
| Minnesota |
| 55101 |
| United States |
| 9412917 | Background | Bampton 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. |
| 17143946 | Background | Bechtold 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. |
| 8181411 | Background | Palakanis 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. |
| 1071419 | Background | Hornblow 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. |
| 8604867 | Background | Todd 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. |
| 9862594 | Background | Singer 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. |
| BG001 | Control | Those randomized into this arm will receive the current routine care which is treatment with a skeletal traction pin and no audio distraction. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Body Mass Index (BMI) | kilograms per square meter (kg/m^2) | Mean | Standard Deviation | kilograms per square meter (kg/m^2) |
|
| Number of Participants with Substance Abuse History | Count of Participants | Participants |
|
| Number of Participants with Smoking History (Yes/No) | Count of Participants | Participants |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | units on a scale | Immediately after the procedure |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | units on a scale | Immediately after the procedure |
|
|
|
| Secondary | Procedure Time | Overall time required for placement of skeletal traction pin | Posted | Mean | Standard Deviation | minutes | Obtained by resident from start of lidocaine injection to end of procedure (disconnecting the drill) (up to 60 minutes). |
|
|
|
| Secondary | 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). | Posted | Mean | Standard Deviation | score on a scale | Immediately after the procedure. |
|
|
|
| 0 |
| 28 |
| 0 |
| 28 |
| 0 |
| 28 |
| EG001 | Control | Those randomized into this arm will receive the current routine care which is treatment with a skeletal traction pin and no audio distraction. | 0 | 26 | 0 | 26 | 0 | 26 |
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