Trial Outcomes & Findings for Audio Distraction for Traction Pin Placement (NCT NCT05927480)
NCT ID: NCT05927480
Last Updated: 2024-12-03
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
54 participants
Primary outcome timeframe
Immediately after the procedure
Results posted on
2024-12-03
Participant Flow
A prospective randomized controlled trial was conducted to from 2018-2022 at two level-I trauma centers across North America.
Of the 54 enrolled participants, all 54 met inclusion criteria and were randomized into the two arms of the study.
Participant milestones
| Measure |
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.
|
Control
Those randomized into this arm will receive the current routine care which is treatment with a skeletal traction pin and no audio distraction.
|
|---|---|---|
|
Overall Study
STARTED
|
28
|
26
|
|
Overall Study
COMPLETED
|
28
|
26
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Audio Distraction
n=28 Participants
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.
|
Control
n=26 Participants
Those randomized into this arm will receive the current routine care which is treatment with a skeletal traction pin and no audio distraction.
|
Total
n=54 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51.2 Years
STANDARD_DEVIATION 21.8 • n=28 Participants
|
52.5 Years
STANDARD_DEVIATION 19.5 • n=26 Participants
|
51.8 Years
STANDARD_DEVIATION 20.6 • n=54 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=28 Participants
|
9 Participants
n=26 Participants
|
23 Participants
n=54 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=28 Participants
|
17 Participants
n=26 Participants
|
31 Participants
n=54 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Body Mass Index (BMI)
|
27.7 kilograms per square meter (kg/m^2)
STANDARD_DEVIATION 5.6 • n=28 Participants
|
29.2 kilograms per square meter (kg/m^2)
STANDARD_DEVIATION 11.8 • n=26 Participants
|
28.5 kilograms per square meter (kg/m^2)
STANDARD_DEVIATION 9.1 • n=54 Participants
|
|
Number of Participants with Substance Abuse History
|
7 Participants
n=28 Participants
|
4 Participants
n=26 Participants
|
11 Participants
n=54 Participants
|
|
Number of Participants with Smoking History (Yes/No)
|
7 Participants
n=28 Participants
|
11 Participants
n=26 Participants
|
18 Participants
n=54 Participants
|
PRIMARY outcome
Timeframe: Immediately after the procedureA 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.
Outcome measures
| Measure |
Audio Distraction
n=28 Participants
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.
|
Control
n=26 Participants
Those randomized into this arm will receive the current routine care which is treatment with a skeletal traction pin and no audio distraction.
|
|---|---|---|
|
Patient-reported Pain
|
5.3 units on a scale
Standard Deviation 3.2
|
6.1 units on a scale
Standard Deviation 2.4
|
PRIMARY outcome
Timeframe: Immediately after the procedureA 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.
Outcome measures
| Measure |
Audio Distraction
n=28 Participants
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.
|
Control
n=26 Participants
Those randomized into this arm will receive the current routine care which is treatment with a skeletal traction pin and no audio distraction.
|
|---|---|---|
|
Patient-reported Anxiety
|
4.8 units on a scale
Standard Deviation 3.3
|
7.1 units on a scale
Standard Deviation 2.8
|
PRIMARY outcome
Timeframe: Immediately after the procedureA 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.
Outcome measures
| Measure |
Audio Distraction
n=28 Participants
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.
|
Control
n=26 Participants
Those randomized into this arm will receive the current routine care which is treatment with a skeletal traction pin and no audio distraction.
|
|---|---|---|
|
Patient-reported Overall Experience
|
3.9 units on a scale
Standard Deviation 2.9
|
3.5 units on a scale
Standard Deviation 2.2
|
SECONDARY outcome
Timeframe: 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
Outcome measures
| Measure |
Audio Distraction
n=28 Participants
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.
|
Control
n=26 Participants
Those randomized into this arm will receive the current routine care which is treatment with a skeletal traction pin and no audio distraction.
|
|---|---|---|
|
Procedure Time
|
16.3 minutes
Standard Deviation 7.9
|
27.2 minutes
Standard Deviation 17.1
|
SECONDARY outcome
Timeframe: 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).
Outcome measures
| Measure |
Audio Distraction
n=28 Participants
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.
|
Control
n=26 Participants
Those randomized into this arm will receive the current routine care which is treatment with a skeletal traction pin and no audio distraction.
|
|---|---|---|
|
Physician Reported Procedure Difficulty
|
2.6 score on a scale
Standard Deviation 2.0
|
2.8 score on a scale
Standard Deviation 1.7
|
Adverse Events
Audio Distraction
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Sandy Vang, Director of Research Administration at Regions Hospital
HealthPartners Institute
Phone: 1-651-254-6961
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place