Virtual Reality Compared to Nitrous Oxide for Labor Analgesia
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Patient satisfaction
Study Overview
Brief Summary
The purpose of this study is to determine if non-invasive distracting devices (Virtual Reality headsets) are non-inferior to conventional therapy (nitrous oxide) for addressing maternal needs during labor who desire non-epidural pain relief.
Detailed Description
The investigators will use a commercially available consumer-grade virtual reality (VR) device and nitrous oxide, a standard of care therapy for laboring women desiring non-epidural analgesic, to determine satisfaction with pain relief with each therapy.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Singleton pregnancy at >34 weeks
- •Regular uterine contractions
- •Pain > 2/10
- •English speaking
Exclusion Criteria
- •BMI > 40
- •Preeclampsia with severe features
- •Use of IV analgesics during labor
- •Diabetes requiring insulin therapy
- •Claustrophobia
- •History of epilepsy
Arms & Interventions
Virtual Reality then Nitrous Oxide
30 minute exposure to virtual reality, 5 minute washout period, then 30 minute exposure to nitrous oxide
Intervention: Oculus Quest 2 Virtual Reality Device (Device)
Virtual Reality then Nitrous Oxide
30 minute exposure to virtual reality, 5 minute washout period, then 30 minute exposure to nitrous oxide
Intervention: Nitrous oxide (Drug)
Nitrous Oxide then Virtual Reality
30 minute exposure to nitrous oxide, 5 minute washout period, then 30 minute exposure to virtual reality
Intervention: Oculus Quest 2 Virtual Reality Device (Device)
Nitrous Oxide then Virtual Reality
30 minute exposure to nitrous oxide, 5 minute washout period, then 30 minute exposure to virtual reality
Intervention: Nitrous oxide (Drug)
Outcomes
Primary Outcomes
Patient satisfaction
Time Frame: 70 minutes
Patient satisfaction with pain relief on a scale of 0-10
Secondary Outcomes
- Pain score(70 minutes)
- Nausea(70 minutes)
- Dizzy(70 minutes)
- Effectiveness(70 minutes)
- Cope with Pain(70 minutes)
- Anxiety(70 minutes)
Investigators
Brendan Carvalho
Chief, Division of Obstetric Anesthesia
Stanford University