NCT02718807CompletedNot Applicable
Use of 3-D Printed Models to Improve Patient Understanding During the Informed Consent Process: A Pilot Study
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 20
- Primary Endpoint
- Difference in questionnaire score
Study Overview
Brief Summary
Pre-made rapid prototyping models will be used to increase patient education versus current methodologies.
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Post-partum
- •Atraumatic delivery of healthy, live infant at HMC
- •Age > 18
- •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
Outcomes
Primary Outcomes
Difference in questionnaire score
Time Frame: through study completion, an average of 1 year
Secondary Outcomes
- Participant Age(through study completion, an average of 1 year)
- Participant Gender(through study completion, an average of 1 year)
- Participant Education Level(through study completion, an average of 1 year)
Investigators
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