Rapid Prototyping Models for Patient Education

January 27, 2022 updated by: Milton S. Hershey Medical Center

Use of 3-D Printed Models to Improve Patient Understanding During the Informed Consent Process: A Pilot Study

Pre-made rapid prototyping models will be used to increase patient education versus current methodologies.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Post-partum women and their co-parent will have a medical condition explained to them first verbally, followed by a questionnaire, and then with the use of anatomical models created by rapid prototyping, followed by a questionnaire. The two questionnaires will then be compared.

Study Type

Observational

Enrollment (Actual)

20

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Post-partum women and respective co-parents who are greater than 18 years of age and fluent in the English language.

Description

Inclusion Criteria:

  • Mother
  • Post-partum
  • Atraumatic delivery of healthy, live infant at HMC
  • Age > 18

Co-parent

  • Co-parent
  • Atraumatic delivery of healthy, live infant at HMC
  • Age > 18

Exclusion Criteria:

  • any pregnancy related issues
  • fetal loss
  • NICU stay > 6 hours
  • Emergent cesarean section
  • Post-partum hemorrhage
  • Hysterectomy
  • Any other condition requiring unplanned, medical intervention during labor and delivery
  • Prior fetal loss or anomaly
  • Inability to read or write English
  • those who do not consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Post-partum Women
Post-partum women following an atraumatic pregnancy.
Other: RP model explanation and questionnaire
Rapid prototyping models of anatomy will be used to demonstrate an anatomic and medical condition and participants will grade the experience on a questionnaire.
Co-Parents
Co-parents to post-partum women following an atraumatic pregnancy.
Other: RP model explanation and questionnaire
Rapid prototyping models of anatomy will be used to demonstrate an anatomic and medical condition and participants will grade the experience on a questionnaire.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Difference in questionnaire score
Time Frame: through study completion, an average of 1 year
through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Participant Age
Time Frame: through study completion, an average of 1 year
through study completion, an average of 1 year
Participant Education Level
Time Frame: through study completion, an average of 1 year
through study completion, an average of 1 year
Participant Gender
Time Frame: through study completion, an average of 1 year
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Milton S. Hershey Medical Center

Investigators

  • Principal Investigator: James Mooney, MD, Milton S. Hershey Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

March 9, 2016

First Submitted That Met QC Criteria

March 18, 2016

First Posted (Estimate)

March 24, 2016

Study Record Updates

Last Update Posted (Actual)

February 11, 2022

Last Update Submitted That Met QC Criteria

January 27, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 3980

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data will not be shared with participants

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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