Audio Distraction for Traction Pin Placement

Not Applicable

Completed

Conditions: Lower Extremity Fracture

Interventions: Behavioral: Audio distraction

Registration Number: NCT05927480

Lead Sponsor: HealthPartners Institute

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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 54

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Audio Distraction	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.

Primary Outcome Measures

Name	Time	Method
Patient-reported Pain	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	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	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.

Secondary Outcome Measures

Name	Time	Method
Procedure Time	Obtained by resident from start of lidocaine injection to end of procedure (disconnecting the drill) (up to 60 minutes).	Overall time required for placement of skeletal traction pin
Physician Reported Procedure Difficulty	Immediately after the procedure.	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).