Audio Distraction for Traction Pin Placement (ADTPP)

HealthPartners Institute

Status: Completed

Conditions: Lower Extremity Fracture

Treatments: Behavioral: Audio distraction

Study type: Interventional

Funder types: Other

Identifiers

NCT05927480

A17-285

Details and patient eligibility

About

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.

Full 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.

Enrollment: 54 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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54 participants in 2 patient groups

Audio Distraction

Experimental group

Description:

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.

Treatment:

Behavioral: Audio distraction

Control

No Intervention group

Description:

Those randomized into this arm will receive the current routine care which is treatment with a skeletal traction pin and no audio distraction.