Virtual Reality Compared to Nitrous Oxide for Labor Analgesia

NCT04749043 | Completed

• 1 other identifier: 59344
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Labor Pain

Keywords

Virtual Reality

Outcome Measures

Primary Outcomes (1)

• Patient satisfaction

  Patient satisfaction with pain relief on a scale of 0-10

  70 minutes

Secondary Outcomes (6)

• Pain score

  70 minutes

• Anxiety

  70 minutes

• Nausea

  70 minutes

• Dizzy

  70 minutes

• Effectiveness

  70 minutes

Study Arms (2)

Virtual Reality then Nitrous Oxide

ACTIVE COMPARATOR

30 minute exposure to virtual reality, 5 minute washout period, then 30 minute exposure to nitrous oxide

Device: Oculus Quest 2 Virtual Reality Device; Drug: Nitrous oxide

Nitrous Oxide then Virtual Reality

ACTIVE COMPARATOR

30 minute exposure to nitrous oxide, 5 minute washout period, then 30 minute exposure to virtual reality

Device: Oculus Quest 2 Virtual Reality Device; Drug: Nitrous oxide

Interventions

Oculus Quest 2 Virtual Reality Device DEVICE

30 min VR experience exposure for labor analgesia. VR experiences include swimming in the ocean, walking through forests, engaging in 3D puzzles, exploring virtual lands, or interacting with musical objects

Nitrous Oxide then Virtual Reality; Virtual Reality then Nitrous Oxide

Nitrous oxide DRUG

30 min exposure for labor analgesia

Nitrous Oxide then Virtual Reality; Virtual Reality then Nitrous Oxide

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Singleton pregnancy at \>34 weeks
• Regular uterine contractions
• Pain \> 2/10
• English speaking

You may not qualify if:

• BMI \> 40
• Preeclampsia with severe features
• Use of IV analgesics during labor
• Diabetes requiring insulin therapy
• Claustrophobia
• History of epilepsy

Sponsors & Collaborators

• Brendan Carvalho: lead

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Labor Pain

Interventions

Nitrous Oxide

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nitrogen Oxides; Gases; Inorganic Chemicals; Nitrogen Compounds; Oxides; Oxygen Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief, Division of Obstetric Anesthesia

Model Details: Comparing VR to an "active control" of nitrous oxide as a current standard of care for non-epidural analgesic in a crossover design

Study Record Dates

• First Submitted: February 2, 2021
• First Posted: February 10, 2021
• Study Start: February 18, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: March 18, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)