Virtual Reality Compared to Nitrous Oxide for Labor Analgesia

Not Applicable

Completed

• Conditions: Labor Pain
• Interventions: Device: Oculus Quest 2 Virtual Reality Device; Drug: Nitrous oxide

• Registration Number: NCT04749043
• Lead Sponsor: Brendan Carvalho

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 Timeline

• Study First Submitted: 2021-02-02
• Study First Submitted QC: 2021-02-08
• Study First Posted: 2021-02-10
• Study Start: 2021-02-18
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-15
• Last Update Posted: 2024-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Nitrous Oxide then Virtual Reality	Oculus Quest 2 Virtual Reality Device	30 minute exposure to nitrous oxide, 5 minute washout period, then 30 minute exposure to virtual reality
Virtual Reality then Nitrous Oxide	Oculus Quest 2 Virtual Reality Device	30 minute exposure to virtual reality, 5 minute washout period, then 30 minute exposure to nitrous oxide
Nitrous Oxide then Virtual Reality	Nitrous oxide	30 minute exposure to nitrous oxide, 5 minute washout period, then 30 minute exposure to virtual reality
Virtual Reality then Nitrous Oxide	Nitrous oxide	30 minute exposure to virtual reality, 5 minute washout period, then 30 minute exposure to nitrous oxide

Primary Outcome Measures

Name	Time	Method
Patient satisfaction	70 minutes	Patient satisfaction with pain relief on a scale of 0-10

Secondary Outcome Measures

Name	Time	Method
Pain score	70 minutes	Pain level on a scale of 0-10
Nausea	70 minutes	Nausea level on a scale of 0-10
Dizzy	70 minutes	Dizziness level on a scale of 0-10
Effectiveness	70 minutes	Effectiveness of device in relieving pain on a scale of 0-10
Cope with Pain	70 minutes	Ability to cope with pain on a scale of 0-10
Anxiety	70 minutes	Anxiety level on a scale of 0-10

Trial Locations

Locations (1)

Stanford University School of Medicine; 🇺🇸 Stanford, California, United States