Audio Distraction for Traction Pin Placement: A Randomized Controlled Trial
Phase: NA
Conditions: Lower Extremity Fracture
Sponsor: HealthPartners Institute

Study Narrative 
Title:  Audio Distraction for Traction Pin Placement: A Randomized Controlled Trial 
8/22/2017 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Participant Contact Project Narrative 
1. Summary  
a. 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.  
 
2. Study aims:  
a. Primary:   
i. To determine if audio distraction will improve subject’s overall experience 
during skeletal traction pin placement compared to those without audio 
distraction. 
ii. To determine if subject anxiety decreases with the use of audio distraction 
compared to those without audio distraction during skeletal traction pin 
placement 
iii. To determine if subject pain decreases with the use of audio distraction 
compared to those without audio distraction during skeletal traction pin 
placement 
 
b. Secondary:  
i. To determine if audio distraction changes provider perception of procedure 
difficulty  
ii. To determine if audio distraction changes overall skeletal traction pin placement 
procedure time 
iii. To determine if pain medicine use is different in patients who have audio 
distraction compared to those without audio distraction during skeletal traction 
pin placement. 
 
3. Background, Rationale, Significance 
a. Lower extremity injuries, including acetabular and mid shaft femur fractures, are 
common injuries seen at trauma centers (Liao, HHS 2015). The incidence of acetabular 
fractures has remained stable at 3/100,000 per year (Laird, JBJ 2005) and diaphyseal 
femur fractures occur at a rate of 1/10,000 per year (Weiss, JBJS 2010). Femur and 
acetabular fractures may disrupt the mechanical axis of the lower extremity, therefore 
causing joint dysfunction if not properly repaired (Probe, AAOS 2003). Due to these 
possible complications, lower extremity fractures are acute issues which are 
immediately addressed in an emergent setting. There has been effort to improve 
outcomes by earlier intervention and surgery (Plaisier, Injury 2000). If these fractures 
are unable to be repaired acutely, the current standard of care in orthopedics is to place 
a skeletal traction pin. 

 
Supracondylar femoral skeletal traction pin placement continues to be the popular 
choice for preoperative stabilization of lower extremity fractures, including acetabular 
and femoral fractures (Resell, 2009). The traction pin theoretically improves pain and 
provides axial reduction of pelvic and lower extremity fractures. This, in theory, 
prevents significant skeletal muscle contraction and improves the ease of fracture 
reduction in the operating room. Traction has also been hypothesized to decrease 
damage to articular cartilage from impingement on bone (Browner, ES 2015).  This has 
been the standard of care for decades in orthopedics and therefore has not been 
adequately studied or demonstrated in the literature.  
 
Skeletal traction is useful in immobilization and stabilization of fractures, and can be 
applied quickly and safely with minimal contraindications (Defroda, EJTES 2016). There 
is also data to support less discomfort with traction pin placement compared to casting 
for lower extremity fractures (Resell 2009). However, the procedure is relatively invasive 
and can cause significant discomfort and anxiety in the patient. The supplies needed 
such as needles for anesthesia, scalpel, traction pin set, drill, and traction frame can be 
intimidating for a patient already experiencing discomfort from a lower extremity 
fracture.  
 
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 (Bampton 1997, Bechtold 2006, Palankis 1994, Silva 
2016, Smolen 2002). The goal of our study is to investigate the use audio distraction 
with subject preferred music from an mp3 player, and the effect on patient anxiety and 
pain during the placement of a skeletal traction pin. Then also retrospectively observe if 
audio distraction alters secondary outcome measures. 
 
b. A pilot study has not been performed, as such there is no preliminary data. However, 
results of studies addressing audio distraction and patient discomfort in Colonoscopy 
procedures identify significant decreases in subject pain [p<0.0001], discomfort 
[p=0.037], and providers’ perception of procedure difficulty [p<0.02] (Bechtold 2006 & 
Costa 2010). These studies also identify significant increases to overall patient 
satisfaction [p<0.0001].  
 
c. This research will be important to the scientific and orthopedic community as it will 
potentially establish a method of improving patient care during a frequently used and 
uncomfortable orthopedic procedure.  
 
4. Approach 
a. Study design  

i. This will be a prospective randomized controlled trial at Regions Hospital in 
Saint Paul, MN and Hennepin County Medical Center in Minneapolis, MN to 
compare primary outcomes of subjects between audio distraction groups during 
traction pin placement. This study will also include a cross-sectional descriptive 
element by examining above listed secondary outcome measures. It will explore 
if either of these outcomes are different between the two subject groups in an 
exploratory fashion. 
 
Group selection was randomized through Microsoft Excel 2010, of which 
subjects are split into blocks of 10, with each block held at a fix ratio of 0.5 for 
audio distraction and without audio distraction.  
i. Inclusion 
1. >18 years old 
2. Conscious, oriented, able to give informed consent 
3. Medical need for  distal femoral or proximal tibial skeletal traction pin 
placement 
ii. Exclusion 
1. Medical contraindication to skeletal traction 
2. Endotracheal intubation 
3. Unable to participate in verbal communication throughout the 
procedure and in the recovery phase 
4. Sensory impairment to pain 
5. Inability to make accurate mark on VAS 2/2 cognitive, motor or visual 
deficiencies.  
 
b. Data collection process  
i. Identify patients at Regions Hospital who meet inclusion criteria who are 
determined to need skeletal traction pin placement  
1. Patients meeting inclusion criteria will be identified by the on call junior 
residents at Regions Hospital and Hennepin County Medical Center 
ii. Recruitment of patients for inclusion in this study will be complete 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.  
iii. Consent 
1. Written informed consent will be obtained by the orthopedic resident 
performing traction pin placement prior to initiating steps for traction 
pin placement 
2. Patients will acknowledge that the study has been explained adequately 
and that they are free to withdraw from study at any time without 
effect on their treatment and management 
3. Patients will provide consent for participation in this study at the time 
of consenting for placement of the skeletal traction pin.  Minors do not 
meet inclusion criteria for this study. 

iv. Data sources needed for this study 
1. Chart review for current injury, date and time of injury, and medications 
given during hospital visit. 
2. Chart Review for patient age, gender, height and weight 
3. Survey for patient 
a. Visual analog scale  (VAS) to rate pain 
b. Visual analog scale (VAS) to rate anxiety 
c. Visual analog scale (VAS) to rate overall patient experience 
4. Survey for resident 
a. Cooperation of patient on 1-10 scale; fully cooperative to 
combative 
b. Ease of procedure on 1-10 scale; easy to most difficult  
5. Overall time required for placement of skeletal traction pin 
v. Process steps for data acquisition  
1. Demographic data (age, sex, injury, date/time of injury)- completed by 
patient; obtained by resident, and/or retrospective chart review by the 
research assistant. 
2. Time of procedure from injection of lidocaine to completion 
(disconnecting drill); obtained by resident 
a. Start time just prior to lidocaine injection 
b. Stop time after drill disconnected from pin 
3. Medications given during procedure; obtained via retrospective chart 
review by research assistant  
4. Post-procedure VAS pain, anxiety, and experience surveys completed by 
patient, obtained by resident immediately after hanging of traction 
weight. 
5. Post-procedure patient compliance and ease of procedure surveys 
completed by the resident after completion of procedure 
 
c. Intervention, treatments 
i. Standard of 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 to listen to genera of music of their choosing in 
addition to be treated to the current standard of care.  Those randomized into 
the control arm will be treated to the current standard of care  
ii. Patients will be randomized by the orthopedic resident into 2 groups; Audio 
distraction with music versus control group with no music.  This will be done by 
sealed envelopes drawn after consent for the procedure.   
 
d. Outcomes/endpoint and other variable definitions, and instruments used   
i. A 10-point visual analog scale for patient experience (1 worst possible 
experience, 10 best possible experience) 
1. Singer 1998; Results suggested that the satisfaction VAS is both reliable 
and valid. 

ii. A 10-point visual analog scale for pain (1 no pain, 10 worst pain) 
1. Bijur 2001; Results demonstrated that the VAS is sufficiently reliable to 
be used to assess acute pain 
2. Todd 1996; demonstrated the validity of the VAS for acute pain 
measurement among ED patients to measure acute pain 
iii. A 10-point visual analog scale for anxiety (1 no anxiety, 10 worst anxiety) 
1. Hornblow 1976; Results suggest that VAS is sufficiently reliable to be 
used to assess acute pain. 
iv. Pain medication used pre/post traction pin placement 
v. Overall time required for placement of skeletal traction pin 
vi. Resident perception of procedural difficulty 
vii. Intermediary Newman-Keuls (SNK) analysis techniques will be utilized to 
regularly perform preliminary post-hoc tests. This will aid towards  
 
e. Statistical analysis plan  
i. T-Test of Sampling Demographic Data 
ii. T-test of Primary Outcome Measures between subject groups 
1. Pain Survey Scores 
2. Anxiety Survey Scores 
3. Experience Survey Scores 
iii. Linear & Logistic Regression Analysis of Primary Outcomes 
1. Addition of Demographic Covariates 
2. Observing both Linear & Non-Linear identities of the relationship. 
iv. T-Test of Secondary Outcome Measures between subject groups 
1. Perception of Difficulty 
2. Procedural Time 
3. Pain Medication 
v. Linear & Logistic Regression Analysis of Secondary Outcomes 
1. Addition of Demographic Covariates 
2. Observing both Linear & Non-Linear identities of the relationship 
vi. Power analysis or statement of precision 
A power analysis was performed to estimate the minimum sample size needed 
to adequately detect a clinically significant change in anxiety and pain scores 
between the audio distraction groups. At a Type I error rate of 0.05 (α=0.05) and 
80% power (β=0.80), the power analysis identifies a minimum sample size of 42 
total participants, 21 for each group. The estimated effect size is 2.0 on the 
utilized 10-point scale with a two-sided standard deviation of two. These 
measures for effect size are adopted from a previously performed colonoscopy 
audio distraction study which identified clinically significant results (Costa 2010). 
A power analysis for secondary outcome measures was not performed due to 
their non-inferential nature. 
vii. Strengths 

1. Regions Hospital and Hennepin County Medical Center provides 
sufficient access to the study population and the facility is adequate to 
conduct the study. Both Level I Trauma centers. 
2. Adequate qualified staff members to conduct the study 
3. Staff will be adequately trained on the protocol and their specific 
research related duties. 
4. Exhaustive primary & secondary outcome assessment. 
5. Use of verified survey techniques. 
6. Conservative effect size estimate compared to previous research. 
viii. Limitations 
1. Traction pin placement is typically done in an acute situation, which 
may limit how much information we will be able to get from the patient 
survey  
2. Subject recall bias with pain measurement 
3. Different techniques for traction pin placement  
a. Attempt to have a standardized procedure for the residents to 
follow 
4. Pain tolerance of patients 
a. This will be controlled by appropriate randomization  
5. Recall bias with procedural difficulty assessment in participating 
resident providers. Comparing procedural difficulty to previous 
experience, not novel. 
 
5. State that a score of five dictates a normal procedural difficulty then rate procedural difficulty 
based on that score. Median value selected on 10-point scale. 
Setting/Environment/Organizational feasibility 
a. This study will be conducted at Regions Hospital in Saint Paul, MN and Hennepin County 
Medical Center (HCMC) in Minneapolis, MN 
b. This HealthPartners setting is a level 1 trauma center with the patient population 
appropriate to carry out the proposed study.  HCMC is a level 1 trauma center with a 
similarly appropriate patient population. 
c. The orthopedic department leadership has been engaged in development and approval 
of this study 
 
6. Risks and Benefits  
a. Potential risk factors with audio distraction group 
i. Patient may not hear resident when attempting to communicate 
1. Resident will be able to communicate with an assistant in the room to 
get the attention of the patient, if needed. 
ii. Patient may receive less pain management with the assumption they will have 
higher pain tolerance from the audio distraction 
1. Resident will continue to follow standard of care for traction pin 
placement 
iii. Benefit for patient in audio distraction group to experience less discomfort 
during traction pin placement 

iv. Benefit to society, as this study may provide an opportunity for providers to 
decrease the level of discomfort in patients who need traction pin placement. 
 
7. Data Confidentiality and Privacy 
a. In order to secure patient confidentiality and data security, all data will be de-identified. 
All patients will be assigned a research identification number (not their MRN) that 
cannot be associated with their name, birthdate, or other identifying information. 
b. Patient information will only be accessed via secure servers for Regions Hospital and on 
encrypted password-protected computers. If it is necessary to transmit patient data, it 
will be transmitted in the de-identified format, using only patient research identification 
numbers. 
i. De-identified data will be shared with collaborating sites (HCMC) 
c. At the end of the study, the electronic files will be permanently deleted and patient 
identifiers will be removed.  All hard copies will be shredded.  
 
8. Timeline 
a. August 2017: IRB submission 
b. September 2017: IRB approval 
c. October 2017: Protocol implementation 
d. October 2017: Patient enrollment  
e. October 2018: Patient enrollment closes 
f. November 2018: Data analysis 
g. December 2018: Manuscript preparation 
h. February 2019: Manuscript submission 
 
9. Dissemination/Sharing Results/Integration and Impact 
a. We do plan on publishing to peer reviewed orthopedic journals such as; 
i. The Journal of Bone and Joint Surgery 
ii. Clinical Orthopedics and Related Research 
iii. Journal of Orthopedic Trauma 
b. We plan to disseminate the information on a local and regional level by presenting at; 
i. University of Minnesota Grand Round 
ii. Regions Department of Orthopedic Surgery Grand Rounds 
iii. Minnesota Orthopedic Society poster presentation 
iv. Mid-America Orthopedic Society poster presentation 
c. Results will be shared with HealthPartners 
i. The results of this project could possibly change the stand of care for placing 
skeletal traction pins at Regions Hospital 
 
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