ClinicalTrials.gov
ClinicalTrials.gov Menu

Use of the Modified Beef Tongue Model for Teaching Repair of Obstetrical Fourth-Degree Laceration to Residents

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03341351
Recruitment Status : Completed
First Posted : November 14, 2017
Last Update Posted : April 18, 2018
Sponsor:
Information provided by (Responsible Party):
Joseph Malek, University of Alabama at Birmingham

Brief Summary:
This is a study evaluating the use of the modified beef tongue model for teaching repair of obstetrical fourth-degree laceration to residents. Participants will be randomized to either an instructional video using the modified beef tongue model or to an instructional workshop using the modified beef tongue model. Primary outcome will be measured as change in technical skills score as measured by change from baseline on a validated objective structured assessment of technical skills (OSTATS) for repair of fourth-degree laceration.

Condition or disease Intervention/treatment Phase
Fourth Degree Perineal Laceration Involving Anal Mucosa Obstetric; Injury Obstetric Labor Complications Other: Instructional video Other: Instructional workshop Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Outcome assessor performing the objective structured assessment of technical skills will be masked to the intervention of the participant.
Primary Purpose: Health Services Research
Official Title: Use of the Modified Beef Tongue Model for Teaching Repair of Obstetrical
Actual Study Start Date : November 14, 2017
Actual Primary Completion Date : March 29, 2018
Actual Study Completion Date : March 29, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears

Arm Intervention/treatment
Active Comparator: Instructional video
The modified beef tongue video group will be given an instructional video created using the modified beef tongue model to show anatomy and proper repair of the laceration.
Other: Instructional video
Instructional video using the modified beef tongue model

Active Comparator: Instructional workshop
The group randomized to the modified beef tongue instructional workshop will undergo an interactive workshop using the modified beef tongue model to show anatomy and proper repair of the laceration.
Other: Instructional workshop
Instructional workshop using the modified beef tongue model.




Primary Outcome Measures :
  1. Technical skills score [ Time Frame: up to 24 weeks ]
    The primary outcome will be change in technical skills score measured as change from baseline in a validated objective structured assessment of technical skills (OSATS) for repair of fourth degree obstetric laceration. This OSATS was described by Siddiqui et al and is based on a task-specific checklist for fourth-degree lacerations and has a maximum score of 20 and minimum score of 0. The higher the score the better the performance.


Secondary Outcome Measures :
  1. Participant preference [ Time Frame: up to 24 weeks ]
    Participant preference of model between instructional video and instructional workshop. Participants will be asked to rate their overall preference between models on a scale of 1 to 10 with 1 being the video and 10 being the instructional workshop.

  2. Knowledge assessment [ Time Frame: up to 24 weeks ]
    Knowledge assessed by written test performed pre- and post-intervention. The written test is the same as the one used by Patel et al to evaluate residents' knowledge about fourth-degree laceration repair. The questions are based on Williams's obstetric chapter on episiotomy repair. The test has a minimum score of 0 and maximum score of 17 with a higher score indicating better performance.

  3. Participant confidence [ Time Frame: up to 24 weeks ]
    Participant's confidence in fourth-degree laceration repair as measured by change in confidence score from pre- to post-intervention. This is based on the participant's response to a 10 point Likert scale with 1 being not confident and 10 being completely confident.

  4. Time of repair [ Time Frame: up to 24 weeks ]
    Time taken for repair of fourth degree laceration

  5. Ease of use of model [ Time Frame: up to 24 weeks ]
    Ease of use of the model as reported by participants. This is based on the participant's response to a 10 point Likert scale with 1 being not easy and 10 being the easiest.

  6. Satisfaction [ Time Frame: up to 24 weeks ]
    Overall satisfaction of each model as reported by participants. This is based on the participant's response to a 10 point Likert scale with 1 being not satisfied and 10 being completely satisfied.

  7. Model realism [ Time Frame: up to 24 weeks ]
    Model realism as reported by participants. This is based on the participant's response to a 10 point Likert scale with 1 being not realistic and 10 being the most realistic.

  8. Factors associated with higher knowledge scores [ Time Frame: up to 24 weeks ]
    Factors associated with higher knowledge scores (e.g. PGY level, number of prior repairs, prior didactics). The written test is the same as the one used by Patel et al to evaluate residents' knowledge about fourth-degree laceration repair. The questions are based on Williams's obstetric chapter on episiotomy repair. The test has a minimum score of 0 and maximum score of 17 with a higher score indicating better performance.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Residents currently in training program at University of Alabama at Birmingham

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03341351


Locations
United States, Alabama
University of Alabama Birmingham Hospital
Birmingham, Alabama, United States, 35233
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
Principal Investigator: Joseph Malek, MD University of Alabama at Birmingham
  Study Documents (Full-Text)

Documents provided by Joseph Malek, University of Alabama at Birmingham:
Informed Consent Form  [PDF] September 29, 2017


Publications:
Responsible Party: Joseph Malek, Instructor/Fellow, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT03341351     History of Changes
Other Study ID Numbers: IRB-300000074
First Posted: November 14, 2017    Key Record Dates
Last Update Posted: April 18, 2018
Last Verified: April 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Joseph Malek, University of Alabama at Birmingham:
Fourth-degree laceration
Beef tongue model

Additional relevant MeSH terms:
Lacerations
Obstetric Labor Complications
Wounds and Injuries
Pregnancy Complications