Rapid Prototyping Models for Patient Education
Sponsor
Milton S. Hershey Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT02718807
Collaborator
(none)
20
8
Study Details
Study Description
Brief Summary
Pre-made rapid prototyping models will be used to increase patient education versus current methodologies.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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
Actual Enrollment
:
20 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Use of 3-D Printed Models to Improve Patient Understanding During the Informed Consent Process: A Pilot Study
Study Start Date
:
May 1, 2016
Actual Primary Completion Date
:
Dec 1, 2016
Actual Study Completion Date
:
Jan 1, 2017
Arms and Interventions
| Arm | 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.
|
Outcome Measures
Primary Outcome Measures
- Difference in questionnaire score [through study completion, an average of 1 year]
Secondary Outcome Measures
- Participant Age [through study completion, an average of 1 year]
- Participant Education Level [through study completion, an average of 1 year]
- Participant Gender [through study completion, an average of 1 year]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Milton S. Hershey Medical Center
Investigators
- Principal Investigator: James Mooney, MD, Milton S. Hershey Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
- Challoner A, Erolin C. Creating pathology models from MRI data: a comparison of virtual 3D modelling and rapid prototyping techniques. J Vis Commun Med. 2013 Jun;36(1-2):11-9. doi: 10.3109/17453054.2013.790011.
- Farrell EH, Whistance RN, Phillips K, Morgan B, Savage K, Lewis V, Kelly M, Blazeby JM, Kinnersley P, Edwards A. Systematic review and meta-analysis of audio-visual information aids for informed consent for invasive healthcare procedures in clinical practice. Patient Educ Couns. 2014 Jan;94(1):20-32. doi: 10.1016/j.pec.2013.08.019. Epub 2013 Aug 30. Review.
- Gonzalez-Cota A, Kruger GH, Raghavan P, Reynolds PI. Computational modeling and prototyping of a pediatric airway management instrument. Anesth Analg. 2010 Sep;111(3):649-52. doi: 10.1213/ANE.0b013e3181e5ea7c. Epub 2010 Jun 25.
- Kinnersley P, Phillips K, Savage K, Kelly MJ, Farrell E, Morgan B, Whistance R, Lewis V, Mann MK, Stephens BL, Blazeby J, Elwyn G, Edwards AG. Interventions to promote informed consent for patients undergoing surgical and other invasive healthcare procedures. Cochrane Database Syst Rev. 2013 Jul 6;(7):CD009445. doi: 10.1002/14651858.CD009445.pub2. Review.
- Mankovich NJ, Cheeseman AM, Stoker NG. The display of three-dimensional anatomy with stereolithographic models. J Digit Imaging. 1990 Aug;3(3):200-3.
- Miller SF, Sanz-Guerrero J, Dodde RE, Johnson DD, Bhawuk A, Gurm HS, Shih AJ. A pulsatile blood vessel system for a femoral arterial access clinical simulation model. Med Eng Phys. 2013 Oct;35(10):1518-24. doi: 10.1016/j.medengphy.2013.04.010. Epub 2013 May 18.
- Mori K, Yamamoto T, Oyama K, Ueno H, Nakao Y, Honma K. Modified three-dimensional skull base model with artificial dura mater, cranial nerves, and venous sinuses for training in skull base surgery: technical note. Neurol Med Chir (Tokyo). 2008 Dec;48(12):582-7; discussion 587-8.
- Noecker AM, Chen JF, Zhou Q, White RD, Kopcak MW, Arruda MJ, Duncan BW. Development of patient-specific three-dimensional pediatric cardiac models. ASAIO J. 2006 May-Jun;52(3):349-53.
- Schubert C, van Langeveld MC, Donoso LA. Innovations in 3D printing: a 3D overview from optics to organs. Br J Ophthalmol. 2014 Feb;98(2):159-61. doi: 10.1136/bjophthalmol-2013-304446. Epub 2013 Nov 28. Review.
- Starosolski ZA, Kan JH, Rosenfeld SD, Krishnamurthy R, Annapragada A. Application of 3-D printing (rapid prototyping) for creating physical models of pediatric orthopedic disorders. Pediatr Radiol. 2014 Feb;44(2):216-21. doi: 10.1007/s00247-013-2788-9. Epub 2013 Nov 8.
- Suzuki M, Ogawa Y, Hagiwara A, Yamaguchi H, Ono H. Rapidly prototyped temporal bone model for otological education. ORL J Otorhinolaryngol Relat Spec. 2004;66(2):62-4.
- Zopf DA, Hollister SJ, Nelson ME, Ohye RG, Green GE. Bioresorbable airway splint created with a three-dimensional printer. N Engl J Med. 2013 May 23;368(21):2043-5. doi: 10.1056/NEJMc1206319.
Responsible Party:
Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier:
NCT02718807
Other Study ID Numbers:
- 3980
First Posted:
Mar 24, 2016
Last Update Posted:
Feb 11, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Milton S. Hershey Medical Center