Lower Extremity Fracture
Conditions
Keywords
Skeletal Traction, Audio Distraction
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.
Interventions
BEHAVIORALAudio distraction
Music on an mp3 player will be provided to the patient for them to listen to while having the traction pin placed.
Sponsors
Jackson Health System
HealthPartners Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
United States
Participant flow
Recruitment details
A prospective randomized controlled trial was conducted to from 2018-2022 at two level-I trauma centers across North America.
Pre-assignment details
Of the 54 enrolled participants, all 54 met inclusion criteria and were randomized into the two arms of the study.
Participants by arm
| Arm | Count |
|---|---|
| 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.
Audio distraction: Music on an mp3 player will be provided to the patient for them to listen to while having the traction pin placed. | 28 |
| Control Those randomized into this arm will receive the current routine care which is treatment with a skeletal traction pin and no audio distraction. | 26 |
| Total | 54 |
Baseline characteristics
| Characteristic | Control | Total | Audio Distraction |
|---|---|---|---|
| Age, Continuous | 52.5 Years STANDARD_DEVIATION 19.5 | 51.8 Years STANDARD_DEVIATION 20.6 | 51.2 Years STANDARD_DEVIATION 21.8 |
| Body Mass Index (BMI) | 29.2 kilograms per square meter (kg/m^2) STANDARD_DEVIATION 11.8 | 28.5 kilograms per square meter (kg/m^2) STANDARD_DEVIATION 9.1 | 27.7 kilograms per square meter (kg/m^2) STANDARD_DEVIATION 5.6 |
| Number of Participants with Smoking History (Yes/No) | 11 Participants | 18 Participants | 7 Participants |
| Number of Participants with Substance Abuse History | 4 Participants | 11 Participants | 7 Participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Sex: Female, Male Female | 9 Participants | 23 Participants | 14 Participants |
| Sex: Female, Male Male | 17 Participants | 31 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 28 | 0 / 26 |
| other Total, other adverse events | 0 / 28 | 0 / 26 |
| serious Total, serious adverse events | 0 / 28 | 0 / 26 |
Outcome results
Primary
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.
Time frame: Immediately after the procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Audio Distraction | Patient-reported Anxiety | 4.8 units on a scale | Standard Deviation 3.3 |
| Control | Patient-reported Anxiety | 7.1 units on a scale | Standard Deviation 2.8 |
Primary
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.
Time frame: Immediately after the procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Audio Distraction | Patient-reported Overall Experience | 3.9 units on a scale | Standard Deviation 2.9 |
| Control | Patient-reported Overall Experience | 3.5 units on a scale | Standard Deviation 2.2 |
Primary
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.
Time frame: Immediately after the procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Audio Distraction | Patient-reported Pain | 5.3 units on a scale | Standard Deviation 3.2 |
| Control | Patient-reported Pain | 6.1 units on a scale | Standard Deviation 2.4 |
Secondary
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).
Time frame: Immediately after the procedure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Audio Distraction | Physician Reported Procedure Difficulty | 2.6 score on a scale | Standard Deviation 2 |
| Control | Physician Reported Procedure Difficulty | 2.8 score on a scale | Standard Deviation 1.7 |
Secondary
Procedure Time
Overall time required for placement of skeletal traction pin
Time frame: Obtained by resident from start of lidocaine injection to end of procedure (disconnecting the drill) (up to 60 minutes).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Audio Distraction | Procedure Time | 16.3 minutes | Standard Deviation 7.9 |
| Control | Procedure Time | 27.2 minutes | Standard Deviation 17.1 |