Audio Distraction for Traction Pin Placement (ADTPP)

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.

Study Overview

• Status: Completed
• Conditions: Lower Extremity Fracture
• Intervention / Treatment: Behavioral: Audio distraction

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 Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • Jackson Memorial Hospital
  • Minnesota
    • Saint Paul, Minnesota, United States, 55101
      • Regions Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Audio distraction; Music on an mp3 player will be provided to the patient for them to listen to while having the traction pin placed.
No Intervention: Control; 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 the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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.

Collaborators and Investigators

• Sponsor: HealthPartners Institute
• Collaborators: Jackson Health System
• Investigators: Principal Investigator: Brian P Cunningham, brian.cunningham@parknicollet.com

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2018
• Primary Completion (Actual): December 19, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: June 6, 2023
• First Submitted That Met QC Criteria: June 28, 2023
• First Posted (Actual): July 3, 2023

Study Record Updates

• Last Update Posted (Actual): December 3, 2024
• Last Update Submitted That Met QC Criteria: November 26, 2024
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Skeletal Traction; Audio Distraction
• Other Study ID Numbers: A17-285

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No