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PI left the institution
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group VR | Experimental | Virtual reality (VR) experience VR visualization of a 3-dimensional relaxing nature scene with the accompanying audio. The patient will be offered a selection of scenes from which to choose, played continuously on a Samsung Gear VRTM(San Jose, CA) headset and headphones. The goal is for the patient to use the intervention for the entire duration of the external cephalic version procedure (ECV), which typically lasts 15 - 30 minutes.The patient will also receive verbal reassurance and coaching as needed. The obstetrician will communicate as usual with the patient. |
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| Group No VR | No Intervention | No intervention will be provided for the control group, who will receive usual management at CUMC, which involves provision of no analgesia or sedation for the procedure, which typically lasts 15 - 30 minutes. Verbal reassurance and coaching is routinely provided by caregivers, including encouraging deep breathing, particularly during painful manipulation of the abdomen, for the duration of the procedure. The obstetrician will communicate as usual with the patient - for example advising that he/she is about to begin the procedure and giving updates as to the degree of success. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual Reality Experience | Other | Virtual reality visualization and experience of a 3-dimensional relaxing nature scene with the accompanying audio. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | The maximal rated pain score will be determined within 5 minutes of the end of the ECV procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| Success of ECV procedure | The successful manipulation of the fetus from the breech to cephalic position | Within 5 minutes of the end of the ECV procedure |
| Rating of the likelihood of choosing the analgesia technique received again |
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Inclusion Criteria:
Exclusion Criteria:
Pregnant women
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| Name | Affiliation | Role |
|---|---|---|
| Allison Lee, MD | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University Irving Medical Center | New York | New York | 10032 | United States |
An excel spreadsheet with data will be available on request.
After data analysis, for an indefinite period of time
An excel spreadsheet with data will be available on request.
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Parallel design, nonblinded, randomized controlled superiority trial
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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)
| Within 2 hours of the end of the procedure |