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

Primary Purpose

Fourth Degree Perineal Laceration Involving Anal Mucosa, Obstetric; Injury, Obstetric Labor Complications

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Instructional video
Instructional workshop
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Fourth Degree Perineal Laceration Involving Anal Mucosa focused on measuring Fourth-degree laceration, Beef tongue model

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Sites / Locations

  • University of Alabama Birmingham Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Instructional video

Instructional workshop

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Technical skills score
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

Participant preference
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.
Knowledge assessment
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.
Participant confidence
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.
Time of repair
Time taken for repair of fourth degree laceration
Ease of use of model
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.
Satisfaction
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.
Model realism
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.
Factors associated with higher knowledge scores
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.

Full Information

First Posted
October 26, 2017
Last Updated
April 17, 2018
Sponsor
University of Alabama at Birmingham
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1. Study Identification

Unique Protocol Identification Number
NCT03341351
Brief Title
Use of the Modified Beef Tongue Model for Teaching Repair of Obstetrical Fourth-Degree Laceration to Residents
Official Title
Use of the Modified Beef Tongue Model for Teaching Repair of Obstetrical
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
November 14, 2017 (Actual)
Primary Completion Date
March 29, 2018 (Actual)
Study Completion Date
March 29, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Institutional Review Board approval has been obtained and written informed consent will be obtained prior to initiation of the study. All obstetrics and gynecology residents at the University of Alabama will be eligible for the study. Eligible residents who desire will be enrolled and consented for the trial. Participants will then complete a short pre-intervention knowledge assessment written test and be asked to rate their confidence level in completing a fourth-degree repair based on a Likert scale. 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 and showed construct validity given a significant difference in scores between postgraduate year (PGY)-1 and PGY-4 residents. Participants will also complete a baseline objective structured assessment of technical skills (OSATS) assessment for repair of fourth-degree obstetric laceration on a commercial anatomical replica, the Sultan Anal Sphincter Trainer (Limbs & Things Inc, Savannah, Georgia). This model comes with a replaceable perineal pad that allows approximately 24 repairs before replacement is necessary. The validated OSATS used will be the assessment described by Siddiqui et al and validated on a surgical model. The repair will be videotaped and then distributed to evaluators who will use the 20 item task specific checklist described by Siddiqui et al. The time taken for the repair will be recorded. Demographic and baseline data will be collected on the participants including PGY level, number of fourth-degree lacerations performed, whether they have read a textbook regarding fourth-degree laceration repair, whether they have read a journal article regarding fourth-degree laceration repair, whether they have attended a didactic session in pelvic anatomy, and whether they have attended a didactic session on fourth-degree laceration repair. Participants will then be randomized into two groups. Randomization will be performed using a computer-generated block design so that each group has a balanced number of residents in each postgraduate year training level. One group will be randomized to the modified beef tongue video and one will be randomized to the modified beef tongue instructional workshop. 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. 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. The modified beef tongue for the video and workshop will be prepared according to the model previously described in the literature. The modified model includes beef tripe (small intestine) used for anal mucosa and chicken leg muscles for anal sphincter muscle analogs. The tripe is tunneled through the body of the trimmed beef tongue and sutured like an ostomy to simulate the anal canal. The tongue is incised toward the tripe "anal canal." Chicken leg muscles are tunneled from the incision out to the cut edges of the beef tongue to create anal sphincter muscle analogs. Following the didactic intervention, participants from each group will be given the written knowledge assessment test again and the objective structured assessment of technical skills (OSATS) for repair of fourth-degree laceration on the commercial anatomical replica again. The time taken for the repair will be recorded. Residents will also be asked to evaluate model realism, ease of use, and satisfaction using a Likert scale. The residents will be asked to assess their confidence again using a Likert scale. The participants will then be crossed over and those who were initially randomized to the video group will then undergo the instructional workshop and the ones initially in the workshop group will be given the instructional video. Participants will then 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. They will also complete the written knowledge test again. The results of this trial may help to inform to a cost- and time-efficient manner of instruction on the repair of 3rd and 4th degree lacerations. A weakness is that it is unclear whether this will translate to effectiveness at the time of an actual third- and fourth-degree repair.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fourth Degree Perineal Laceration Involving Anal Mucosa, Obstetric; Injury, Obstetric Labor Complications
Keywords
Fourth-degree laceration, Beef tongue model

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Outcome assessor performing the objective structured assessment of technical skills will be masked to the intervention of the participant.
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Instructional video
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Instructional workshop
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Instructional video
Intervention Description
Instructional video using the modified beef tongue model
Intervention Type
Other
Intervention Name(s)
Instructional workshop
Intervention Description
Instructional workshop using the modified beef tongue model.
Primary Outcome Measure Information:
Title
Technical skills score
Description
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.
Time Frame
up to 24 weeks
Secondary Outcome Measure Information:
Title
Participant preference
Description
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.
Time Frame
up to 24 weeks
Title
Knowledge assessment
Description
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.
Time Frame
up to 24 weeks
Title
Participant confidence
Description
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.
Time Frame
up to 24 weeks
Title
Time of repair
Description
Time taken for repair of fourth degree laceration
Time Frame
up to 24 weeks
Title
Ease of use of model
Description
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.
Time Frame
up to 24 weeks
Title
Satisfaction
Description
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.
Time Frame
up to 24 weeks
Title
Model realism
Description
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.
Time Frame
up to 24 weeks
Title
Factors associated with higher knowledge scores
Description
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.
Time Frame
up to 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Residents currently in training program at University of Alabama at Birmingham Exclusion Criteria: None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph Malek, MD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama Birmingham Hospital
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19084100
Citation
Siddiqui NY, Stepp KJ, Lasch SJ, Mangel JM, Wu JM. Objective structured assessment of technical skills for repair of fourth-degree perineal lacerations. Am J Obstet Gynecol. 2008 Dec;199(6):676.e1-6. doi: 10.1016/j.ajog.2008.07.054.
Results Reference
background
PubMed Identifier
19924368
Citation
Patel M, LaSala C, Tulikangas P, O'Sullivan DM, Steinberg AC. Use of a beef tongue model and instructional video for teaching residents fourth-degree laceration repair. Int Urogynecol J. 2010 Mar;21(3):353-8. doi: 10.1007/s00192-009-1042-3.
Results Reference
background
PubMed Identifier
28178060
Citation
Illston JD, Ballard AC, Ellington DR, Richter HE. Modified Beef Tongue Model for Fourth-Degree Laceration Repair Simulation. Obstet Gynecol. 2017 Mar;129(3):491-496. doi: 10.1097/AOG.0000000000001908.
Results Reference
background

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

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