Virtual Reality for External Cephalic Version

NCT03588182 | Terminated

• 1 other identifier: AAAR9073
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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).

Conditions

Analgesia Management for External Cephalic Version

Keywords

Virtual Reality (VR)

Outcome Measures

Primary Outcomes (1)

• Mean maximal numerical rating scale (NRS) score ( scale 0 - 10) for pain during the ECV procedure.

  Verbal rating of pain (scale 0 - 10) during ECV procedure, rated every 5 minutes

  The maximal rated pain score will be determined within 5 minutes of the end of the ECV procedure.

Secondary Outcomes (2)

• Success of ECV procedure

  Within 5 minutes of the end of the ECV procedure

• Rating of the likelihood of choosing the analgesia technique received again

  Within 2 hours of the end of the procedure

Study Arms (2)

Group VR

EXPERIMENTAL

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

Group No VR

NO INTERVENTION

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.

Interventions

Virtual Reality Experience OTHER

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

Group VR

Eligibility Criteria

• Age: 18 Years - 55 Years
• Gender Eligibility Details: Pregnant women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• \) 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.

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

Study Officials

• Allison Lee, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel design, nonblinded, randomized controlled superiority trial

Study Record Dates

• First Submitted: July 4, 2018
• First Posted: July 17, 2018
• Study Start: May 18, 2019
• Primary Completion: December 6, 2023
• Study Completion: December 6, 2023
• Last Updated: May 13, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: After data analysis, for an indefinite period of time
• Access Criteria: An excel spreadsheet with data will be available on request.

Locations

US (1)