Lower Extremity Fracture Clinical Trial
— ADTPPOfficial title:
Audio Distraction for Traction Pin Placement: A Randomized Controlled Trial
Verified date | May 2023 |
Source | HealthPartners Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
United States | Jackson Memorial Hospital | Miami | Florida |
United States | Regions Hospital | Saint Paul | Minnesota |
Lead Sponsor | Collaborator |
---|---|
HealthPartners Institute | Jackson Health System |
United States,
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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. |
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