This will be a parallel design, nonblinded, randomized controlled superiority trial investigating the utility of a virtual reality (VR) experience to provide analgesia for external cephalic version (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 Irving Medical Center (CUIMC) with a plan to receive no anesthesia for the procedure. Patients will be randomly assigned to either the VR or No VR group. The intervention will be provided for the duration of the ECV procedure (typically 15 - 30 mins).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
5
Virtual reality visualization and experience of a 3-dimensional relaxing nature scene with the accompanying audio.
Columbia University Irving Medical Center
New York, New York, United States
Mean maximal numerical rating scale (NRS) score ( scale 0 - 10) for pain during the ECV procedure.
Verbal rating of pain (scale 0 - 10) during ECV procedure, rated every 5 minutes
Time frame: The maximal rated pain score will be determined within 5 minutes of the end of the ECV procedure.
Success of ECV procedure
The successful manipulation of the fetus from the breech to cephalic position
Time frame: Within 5 minutes of the end of the ECV procedure
Rating of the likelihood of choosing the analgesia technique received again
Verbal rating of likelihood to choose the analgesia technique received again (scale 1 - 5, where 1 = I would not utilize again, 5 = I would definitely utilize again)
Time frame: Within 2 hours of the end of the procedure
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