Virtual Reality Compared to Nitrous Oxide for Labor Analgesia

March 15, 2024 updated by: Brendan Carvalho
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305
        • Stanford University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Virtual Reality then Nitrous Oxide
30 minute exposure to virtual reality, 5 minute washout period, then 30 minute exposure to nitrous oxide
Device: Oculus Quest 2 Virtual Reality 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
Drug: Nitrous oxide
30 min exposure for labor analgesia
Active Comparator: Nitrous Oxide then Virtual Reality
30 minute exposure to nitrous oxide, 5 minute washout period, then 30 minute exposure to virtual reality
Device: Oculus Quest 2 Virtual Reality 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
Drug: Nitrous oxide
30 min exposure for labor analgesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient satisfaction
Time Frame: 70 minutes
Patient satisfaction with pain relief on a scale of 0-10
70 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain score
Time Frame: 70 minutes
Pain level on a scale of 0-10
70 minutes
Anxiety
Time Frame: 70 minutes
Anxiety level on a scale of 0-10
70 minutes
Nausea
Time Frame: 70 minutes
Nausea level on a scale of 0-10
70 minutes
Dizzy
Time Frame: 70 minutes
Dizziness level on a scale of 0-10
70 minutes
Effectiveness
Time Frame: 70 minutes
Effectiveness of device in relieving pain on a scale of 0-10
70 minutes
Cope with Pain
Time Frame: 70 minutes
Ability to cope with pain on a scale of 0-10
70 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brendan Carvalho

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 18, 2021

Primary Completion (Actual)

December 31, 2023

Study Completion (Actual)

December 31, 2023

Study Registration Dates

First Submitted

February 2, 2021

First Submitted That Met QC Criteria

February 8, 2021

First Posted (Actual)

February 10, 2021

Study Record Updates

Last Update Posted (Actual)

March 18, 2024

Last Update Submitted That Met QC Criteria

March 15, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 59344

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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