Virtual Reality for External Cephalic Version



Status:Recruiting
Healthy:No
Age Range:18 - 55
Updated:1/13/2019
Start Date:August 1, 2019
End Date:August 1, 2020
Contact:Allison Lee, MD
Email:al3196@cumc.columbia.edu
Phone:212 342 2028

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Virtual Reality Analgesia for External Cephalic Version

This will be a parallel design, nonblinded, randomized controlled superiority trial
investigating the utility of a VR experience to provide analgesia for ECV.

Subjects will be: Pregnant women, age >18 years, with a singleton pregnancy at >36 weeks
gestational age, healthy (American Society of Anesthesiologists physical status class II),
with an otherwise uncomplicated pregnancy (i.e. no fetal abnormalities or significant
maternal morbidity, scheduled for ECV at Columbia University Medical Center (CUMC) with a
plan to receive no anesthesia for the procedure.

Patients will be randomly assigned to either the VR (GROUP VR) or No VR group (GROUP NO_VR).
The intervention will be provided for the duration of the ECV procedure (typically 15 - 30
mins).

Inclusion Criteria:

- Pregnant women, age >18 years, with a singleton pregnancy at >36 weeks gestational
age, healthy (American Society of Anesthesiologists physical status class II), with an
otherwise uncomplicated pregnancy (i.e. no fetal abnormalities or significant maternal
morbidity, scheduled for ECV at CUMC with a plan to receive no anesthesia for the
procedure.

Exclusion Criteria:

- 1) severe claustrophobia or other psychological/psychiatric disorder which would
prevent the use of a VR headset; 2) history of severe motion sickness, which may lead
to nausea and vomiting or other discomfort with use of the a VR headset; 3) severe
visual impairment, which may prevent appreciation of the visual aspects of the VR
environment presented; 4) severe auditory impairment, which may prevent full
appreciation of the sounds presented in the VR environment; 5) facial skin or scalp
open lesions which could be irritated or risk infection to the patient or others if
the VR headset is used; 6) other viral/bacterial/fungal infectious illnesses that
could easily be spread by sharing of the device e.g. viral or bacterial
conjunctivitis, meningitis, influenza, common cold, and other upper respiratory tract
infections; 7) severe or uncontrolled seizure disorder, as the VR experience could
invoke seizures 8) bulky hairstyles which would significantly impair correct fitting
of the VR headset.
We found this trial at
1
site
630 W 168th St
New York, New York
212-305-2862
Phone: 212-342-2028
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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mi
from
New York, NY
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