NCT03588182

Virtual Reality for External Cephalic Version

Virtual Reality Analgesia for External Cephalic Version

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Columbia University · Academic / Other
• Sex: Female
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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).

Conditions

• Analgesia Management for External Cephalic Version

Interventions

Type	Name	Description
OTHER	Virtual Reality Experience	Virtual reality visualization and experience of a 3-dimensional relaxing nature scene with the accompanying audio.

Timeline

• Start date: 2019-05-18
• Primary completion: 2023-12-06
• Completion: 2023-12-06
• First posted: 2018-07-17
• Last updated: 2024-05-13

Locations

1 site across 1 country: United States