Clinical trial NCT03588182: Virtual Reality for External Cephalic Version
Official title: Virtual Reality Analgesia for External Cephalic Version
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Analgesia Management for External Cephalic Version
Keywords: Virtual Reality (VR)
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2018-07-17
Enrollment: 5
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel design, nonblinded, randomized controlled superiority trial
Primary purpose: OTHER

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).

Eligibility criteria: 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.

Primary outcomes:
measure: 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.
Secondary outcomes:
measure: Success of ECV procedure
timeFrame: Within 5 minutes of the end of the ECV procedure
measure: Rating of the likelihood of choosing the analgesia technique received again
timeFrame: Within 2 hours of the end of the procedure
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Allison Lee, MD
role: PRINCIPAL_INVESTIGATOR
References: