Audio Distraction for Traction Pin Placement

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Audio Distraction for Traction Pin Placement: A Randomized Controlled Trial

Conditions
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Lower Extremity Fracture

Intervention / Treatment
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* Behavioral: Audio distraction


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Audio Distraction<br>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<br>* Music on an mp3 player will be provided to the patient for them to listen to while having the traction pin placed.<br>|
| No Intervention: Control<br>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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Experience | A 10-point visual analog scale for patient experience with 1 being the worst possible outcome and 10 being the best possible outcome. Scale is from 1-10. | Immediately after the procedure | 
| Patient 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 Anxiety | A 10-point visual analog scale for anxiety with 1 being the worst possible outcome and 10 being the best possible outcome. Scale is from 1-10. | Immediately after the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain medication | Pain medication used pre/post traction pin placement by the resident to be verified via chart review | up to 2 weeks | 
| 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). | 
| Provider ease of procedure | Resident will fill out survey after the procedure to evaluate the difficulty of the procedure. Cooperation of patient on 1-10 scale; fully cooperative to combative. Ease of procedure on 1-10 scale; easy to most difficult. | Immediately after the procedure. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Skeletal Traction, Audio Distraction