Rapid Prototyping Models for Patient Education

NCT ID: NCT02718807

Last Updated: 2022-02-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-05-31

Study Completion Date

2017-01-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Patient Education

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Post-partum Women

Post-partum women following an atraumatic pregnancy.

RP model explanation and questionnaire

Intervention Type 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

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

RP model explanation and questionnaire

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Milton S. Hershey Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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James Mooney, MD

Role: PRINCIPAL_INVESTIGATOR

Milton S. Hershey Medical Center

References

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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.

Reference Type BACKGROUND
PMID: 23832767 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24041712 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23641760 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20581164 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 2085555 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19106500 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23688608 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16760727 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24288392 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24202430 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15162002 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23697530 (View on PubMed)

Other Identifiers

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3980

Identifier Type: -

Identifier Source: org_study_id

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