Analgesia Management for External Cephalic Version
Conditions
Keywords
Virtual Reality (VR)
Brief 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).
Detailed description
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).
Interventions
Virtual reality visualization and experience of a 3-dimensional relaxing nature scene with the accompanying audio.
Sponsors
Columbia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
Parallel design, nonblinded, randomized controlled superiority trial
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean maximal numerical rating scale (NRS) score ( scale 0 - 10) for pain during the ECV procedure. | The maximal rated pain score will be determined within 5 minutes of the end of the ECV procedure. | Verbal rating of pain (scale 0 - 10) during ECV procedure, rated every 5 minutes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Success of ECV procedure | Within 5 minutes of the end of the ECV procedure | The successful manipulation of the fetus from the breech to cephalic position |
| Rating of the likelihood of choosing the analgesia technique received again | Within 2 hours of the end of the procedure | 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) |
Countries
United States
Outcome results
None listed