Virtual Reality for External Cephalic Version (NCT03588182) | Clinical Trial Compass
TerminatedNot Applicable
Virtual Reality for External Cephalic Version
Stopped: PI left the institution
United States5 participantsStarted 2019-05-18
Plain-language summary
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).
Who can participate
Age range18 Years ā 55 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
What they're measuring
1
Mean maximal numerical rating scale (NRS) score ( scale 0 - 10) for pain during the ECV procedure.
Timeframe: The maximal rated pain score will be determined within 5 minutes of the end of the ECV procedure.