Skip to main content
OpenTrials
Completed

NCT Number: NCT05927480

Audio Distraction for Traction Pin Placement

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Lower Extremity Fracture

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jackson Memorial Hospital, Miami, Florida, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Patient-reported Pain

    Time frame: 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.

  2. Patient-reported Anxiety

    Time frame: 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.

  3. Patient-reported Overall Experience

    Time frame: 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 outcomes

  1. Procedure Time

    Time frame: 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

  2. Physician Reported Procedure Difficulty

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

HealthPartners Institute

Other

Collaborators

  • Jackson Health System

Registry information

Official study title

Audio Distraction for Traction Pin Placement: A Randomized Controlled Trial

Acronym: ADTPP

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Jul 3, 2023
Registry last updated
Dec 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.