MedDataX Logo

Audio Distraction for Traction Pin Placement

NCT ID: NCT05927480

Last Updated: 2024-12-03

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-25

Study Completion Date

2022-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Lower Extremity Fracture

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Audio distraction

Intervention Type BEHAVIORAL

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Audio distraction

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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Jackson Health System

OTHER

Sponsor Role collaborator

HealthPartners Institute

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Brian P Cunningham

Role: PRINCIPAL_INVESTIGATOR

[email protected]

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Jackson Memorial Hospital

Miami, Florida, United States

Site Status

Regions Hospital

Saint Paul, Minnesota, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 27448398 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9703402 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9412917 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17143946 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8181411 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 1071419 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8604867 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9862594 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

A17-285

Identifier Type: -

Identifier Source: org_study_id