NCT03437031

Virtual Reality in Labor and Delivery for Reduction in Pain

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Cedars-Sinai Medical Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to identify whether use of virtual reality devices can improve the pain management of women in labor and delivery. The investigators will perform a randomized controlled trial of patients in labor at Cedars-Sinai Medical Center.

Detailed description

The purpose of this study is to identify whether use of virtual reality devices can improve the pain management of women in labor and delivery. The investigators hypothesize that use of virtual reality devices will result in a reduction in pain medication use, in epidural use, and prolong the duration of time prior to the patient receiving an epidural. The study will be conducted as two parallel randomized controlled trials: one for latent labor patients and one for patients in active labor (defined by whether they are \< 6 cm or \> 6 cm). Within each phase of labor, there will be 20 in the Virtual Reality arm and 20 in the Control arm for a total of 80 patients.

Conditions

• Labor Pain
• Virtual Reality
• Alternative Medicine

Interventions

Type	Name	Description
DEVICE	Virtual Reality device	For those patients randomized to VR, the study staff member will explain the use of the Samsung VR goggle set, and thereafter will allow the patient to use the device freely for up to 30 minutes. Intervals of 2-5 minutes is suggested for first-time use, and patients will be to allowed to discontinue it at any time as long as they are not experiencing any discomfort or side effects (dizziness, motion sickness, etc.). The study staff member will be present at all times, and will work with hospital staff as necessary to ensure the patient is receiving appropriate clinical care throughout the duration of the intervention.

Timeline

• Start date: 2018-03-01
• Primary completion: 2019-02-19
• Completion: 2019-02-19
• First posted: 2018-02-19
• Last updated: 2021-11-26
• Results posted: 2021-11-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study