Virtual Reality for External Cephalic Version

• ClinicalTrials.gov Identifier: NCT03588182
• Recruitment Status: Active, not recruiting
• First Posted: July 17, 2018
• Last Update Posted: July 13, 2021
• Sponsor: Columbia University
• Information provided by (Responsible Party): Columbia University

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Analgesia Management for External Cephalic Version	Other: Virtual Reality Experience	Not Applicable

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).

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 52 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Parallel design, nonblinded, randomized controlled superiority trial
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Virtual Reality Analgesia for External Cephalic Version
• Actual Study Start Date: May 18, 2019
• Estimated Primary Completion Date: April 2022
• Estimated Study Completion Date: April 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	Other: Virtual Reality Experience; Virtual reality visualization and experience of a 3-dimensional relaxing nature scene with the accompanying audio.
No Intervention: 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.

Outcome Measures

Primary Outcome Measures :

1. Mean maximal numerical rating scale (NRS) score ( scale 0 - 10) for pain during the ECV procedure. [ Time Frame: 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 Outcome Measures :

1. Success of ECV procedure [ Time Frame: Within 5 minutes of the end of the ECV procedure ]
   The successful manipulation of the fetus from the breech to cephalic position
2. Rating of the likelihood of choosing the analgesia technique received again [ Time Frame: 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)

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 55 Years (Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Pregnant women
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

United States, New York

Columbia University Irving Medical Center

New York, New York, United States, 10032

Sponsors and Collaborators

Columbia University

Investigators

• Principal Investigator: Allison Lee, MD; Columbia University

More Information

• Responsible Party: Columbia University
• ClinicalTrials.gov Identifier: NCT03588182
• Other Study ID Numbers: AAAR9073
• First Posted: July 17, 2018
• Last Update Posted: July 13, 2021
• Last Verified: July 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: An excel spreadsheet with data will be available on request.
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF)
• Time Frame: After data analysis, for an indefinite period of time
• Access Criteria: An excel spreadsheet with data will be available on request.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Columbia University:

Virtual Reality (VR)