Virtual Reality for External Cephalic Version

NCT ID: NCT03588182

Last Updated: 2024-05-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-18
• Study Completion Date: 2023-12-06

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).

Conditions

Analgesia Management for External Cephalic Version

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Group VR

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.

Group Type: EXPERIMENTAL

Virtual Reality Experience

Intervention Type: OTHER

Virtual reality visualization and experience of a 3-dimensional relaxing nature scene with the accompanying audio.

Group No VR

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Virtual Reality Experience

Virtual reality visualization and experience of a 3-dimensional relaxing nature scene with the accompanying audio.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Allison Lee, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

Columbia University Irving Medical Center

New York, New York, United States

Countries

United States

Other Identifiers

AAAR9073

Identifier Type: -

Identifier Source: org_study_id