Virtual Reality Compared to Nitrous Oxide for Labor Analgesia

NCT ID: NCT04749043

Last Updated: 2024-03-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-18

Study Completion Date

2023-12-31

Brief Summary

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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

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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.

Conditions

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Labor Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Comparing VR to an "active control" of nitrous oxide as a current standard of care for non-epidural analgesic in a crossover design
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Virtual Reality then Nitrous Oxide

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

Group Type ACTIVE_COMPARATOR

Oculus Quest 2 Virtual Reality Device

Intervention Type 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

Intervention Type DRUG

30 min exposure for labor analgesia

Nitrous Oxide then Virtual Reality

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

Group Type ACTIVE_COMPARATOR

Oculus Quest 2 Virtual Reality Device

Intervention Type 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

Intervention Type DRUG

30 min exposure for labor analgesia

Interventions

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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

Intervention Type DEVICE

Nitrous oxide

30 min exposure for labor analgesia

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Brendan Carvalho

OTHER

Sponsor Role lead

Responsible Party

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Brendan Carvalho

Chief, Division of Obstetric Anesthesia

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Stanford University School of Medicine

Stanford, California, United States

Site Status

Countries

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United States

Other Identifiers

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59344

Identifier Type: -

Identifier Source: org_study_id

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