Audio Distraction for Traction Pin Placement

NCT05927480 | Completed Results

• 1 other identifier: A17-285
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Lower Extremity Fracture

Keywords

Skeletal Traction; Audio Distraction

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (2)

• Procedure Time

  Obtained by resident from start of lidocaine injection to end of procedure (disconnecting the drill) (up to 60 minutes).

• Physician Reported Procedure Difficulty

  Immediately after the procedure.

Study Arms (2)

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.

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.

Interventions

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.

Audio Distraction

Eligibility Criteria

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

You may qualify if:

• Conscious, oriented, able to give informed consent
• Medical need for distal femoral or proximal tibial skeletal traction pin placement

You may not qualify if:

• 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.

Sponsors & Collaborators

• HealthPartners Institute: lead
• Jackson Health System: collaborator

Study Sites (2)

Jackson Memorial Hospital

Miami, Florida, 33136, United States

Location

Regions Hospital

Saint Paul, Minnesota, 55101, United States

Location

Related Publications (8)

• 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.

  PMID: 27448398 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.

  PMID: 9703402 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.

  PMID: 9412917 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.

  PMID: 17143946 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.

  PMID: 8181411 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.

  PMID: 1071419 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.

  PMID: 8604867 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.

  PMID: 9862594 BACKGROUND

Results Point of Contact

• Title: Sandy Vang, Director of Research Administration at Regions Hospital
• Organization: HealthPartners Institute

sandy.x.vang@healthpartners.com

1-651-254-6961

Study Officials

• Brian P Cunningham

  brian.cunningham@parknicollet.com

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 6, 2023
• First Posted: July 3, 2023
• Study Start: April 25, 2018
• Primary Completion: December 19, 2022
• Study Completion: December 31, 2022
• Last Updated: December 3, 2024
• Results First Posted: December 3, 2024

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)