Patient Education Clinical Trial
Official title:
Use of 3-D Printed Models to Improve Patient Understanding During the Informed Consent Process: A Pilot Study
NCT number | NCT02718807 |
Other study ID # | 3980 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | May 2016 |
Est. completion date | January 2017 |
Verified date | January 2022 |
Source | Milton S. Hershey Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Pre-made rapid prototyping models will be used to increase patient education versus current methodologies.
Status | Completed |
Enrollment | 20 |
Est. completion date | January 2017 |
Est. primary completion date | December 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Milton S. Hershey Medical Center |
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Mankovich NJ, Cheeseman AM, Stoker NG. The display of three-dimensional anatomy with stereolithographic models. J Digit Imaging. 1990 Aug;3(3):200-3. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Difference in questionnaire score | through study completion, an average of 1 year | ||
Secondary | Participant Age | through study completion, an average of 1 year | ||
Secondary | Participant Education Level | through study completion, an average of 1 year | ||
Secondary | Participant Gender | through study completion, an average of 1 year |
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