Rapid Prototyping Models for Patient Education

NCT02718807 | Completed

• 1 other identifier: 3980
• Study Type: observational
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Patient Education

Keywords

Patient Care; Education

Outcome Measures

Primary Outcomes (1)

• Difference in questionnaire score

  through study completion, an average of 1 year

Secondary Outcomes (3)

• 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

Study Arms (2)

Post-partum Women

Post-partum women following an atraumatic pregnancy.

Other: RP model explanation and questionnaire

Co-Parents

Co-parents to post-partum women following an atraumatic pregnancy.

Other: RP model explanation and questionnaire

Interventions

RP model explanation and questionnaire OTHER

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; Post-partum Women

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

Related Publications (12)

• 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;2013(7):CD009445. doi: 10.1002/14651858.CD009445.pub2.

  PMID: 23832767 BACKGROUND

• 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.

  PMID: 24041712 BACKGROUND

• 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.

  PMID: 23641760 BACKGROUND

• 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.

  PMID: 20581164 BACKGROUND

• Mankovich NJ, Cheeseman AM, Stoker NG. The display of three-dimensional anatomy with stereolithographic models. J Digit Imaging. 1990 Aug;3(3):200-3. doi: 10.1007/BF03167610.

  PMID: 2085555 BACKGROUND

• 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. doi: 10.2176/nmc.48.582.

  PMID: 19106500 BACKGROUND

• 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.

  PMID: 23688608 BACKGROUND

• 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. doi: 10.1097/01.mat.0000217962.98619.ab.

  PMID: 16760727 BACKGROUND

• 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.

  PMID: 24288392 BACKGROUND

• 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.

  PMID: 24202430 BACKGROUND

• 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. doi: 10.1159/000077796.

  PMID: 15162002 BACKGROUND

• 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. No abstract available.

  PMID: 23697530 BACKGROUND

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• James Mooney, MD

  Milton S. Hershey Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2016
• First Posted: March 24, 2016
• Study Start: May 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: January 1, 2017
• Last Updated: February 11, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share