Audio Distraction for Traction Pin Placement

Lower Extremity Fracture Clinical Trial

— ADTPP  

Official title:

Audio Distraction for Traction Pin Placement: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05927480
• Other study ID #: A17-285
• Status: Completed
• Phase: N/A
• Start date: April 25, 2018
• Est. completion date: December 31, 2022

Study information

• Verified date: May 2023
• Source: HealthPartners Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: December 31, 2022
• Est. primary completion date: December 19, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lower Extremity Fracture

Intervention

Behavioral:
• Audio distraction
Music on an mp3 player will be provided to the patient for them to listen to while having the traction pin placed.

Locations

Country	Name	City	State
United States	Jackson Memorial Hospital	Miami	Florida
United States	Regions Hospital	Saint Paul	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
HealthPartners Institute	Jackson Health System

Country where clinical trial is conducted

United States, 

References & Publications (8)

Bampton P, Draper B. Effect of relaxation music on patient tolerance of gastrointestinal endoscopic procedures. J Clin Gastroenterol. 1997 Jul;25(1):343-5. doi: 10.1097/00004836-199707000-00010. — View Citation

Bechtold ML, Perez RA, Puli SR, Marshall JB. Effect of music on patients undergoing outpatient colonoscopy. World J Gastroenterol. 2006 Dec 7;12(45):7309-12. doi: 10.3748/wjg.v12.i45.7309. — View Citation

DeFroda SF, Gil JA, Born CT. Indications and anatomic landmarks for the application of lower extremity traction: a review. Eur J Trauma Emerg Surg. 2016 Dec;42(6):695-700. doi: 10.1007/s00068-016-0712-3. Epub 2016 Jul 23. — View Citation

Hornblow AR, Kidson MA. The visual analogue scale for anxiety: a validation study. Aust N Z J Psychiatry. 1976 Dec;10(4):339-41. doi: 10.3109/00048677609159523. No abstract available. — View Citation

Palakanis KC, DeNobile JW, Sweeney WB, Blankenship CL. Effect of music therapy on state anxiety in patients undergoing flexible sigmoidoscopy. Dis Colon Rectum. 1994 May;37(5):478-81. doi: 10.1007/BF02076195. — View Citation

Resch S, Thorngren KG. Preoperative traction for hip fracture: a randomized comparison between skin and skeletal traction in 78 patients. Acta Orthop Scand. 1998 Jun;69(3):277-9. doi: 10.3109/17453679809000929. — View Citation

Singer AJ, Thode HC Jr. Determination of the minimal clinically significant difference on a patient visual analog satisfaction scale. Acad Emerg Med. 1998 Oct;5(10):1007-11. doi: 10.1111/j.1553-2712.1998.tb02781.x. — View Citation

Todd KH, Funk KG, Funk JP, Bonacci R. Clinical significance of reported changes in pain severity. Ann Emerg Med. 1996 Apr;27(4):485-9. doi: 10.1016/s0196-0644(96)70238-x. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Experience	A 10-point visual analog scale for patient experience with 1 being the worst possible outcome and 10 being the best possible outcome. Scale is from 1-10.	Immediately after the procedure
Primary	Patient 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.	Immediately after the procedure
Primary	Patient Anxiety	A 10-point visual analog scale for anxiety with 1 being the worst possible outcome and 10 being the best possible outcome. Scale is from 1-10.	Immediately after the procedure
Secondary	Pain medication	Pain medication used pre/post traction pin placement by the resident to be verified via chart review	up to 2 weeks
Secondary	Procedure time	Overall time required for placement of skeletal traction pin	Obtained by resident from start of lidocaine injection to end of procedure (disconnecting the drill) (up to 60 minutes).
Secondary	Provider ease of procedure	Resident will fill out survey after the procedure to evaluate the difficulty of the procedure. Cooperation of patient on 1-10 scale; fully cooperative to combative. Ease of procedure on 1-10 scale; easy to most difficult.	Immediately after the procedure.