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Virtual Reality Compared to Nitrous Oxide for Labor Analgesia

Virtual Reality Compared to Nitrous Oxide for Labor Analgesia

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04749043
Enrollment
20
Registered
2021-02-10
Start date
2021-02-18
Completion date
2023-12-31
Last updated
2024-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Labor Pain

Keywords

Virtual Reality

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.

Interventions

DEVICEOculus 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

DRUGNitrous oxide

30 min exposure for labor analgesia

Sponsors

Brendan Carvalho
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

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

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Patient satisfaction70 minutesPatient satisfaction with pain relief on a scale of 0-10

Secondary

MeasureTime frameDescription
Effectiveness70 minutesEffectiveness of device in relieving pain on a scale of 0-10
Cope with Pain70 minutesAbility to cope with pain on a scale of 0-10
Dizzy70 minutesDizziness level on a scale of 0-10
Anxiety70 minutesAnxiety level on a scale of 0-10
Nausea70 minutesNausea level on a scale of 0-10
Pain score70 minutesPain level on a scale of 0-10

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026