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OpenTrials
Completed

NCT Number: NCT04749043

Virtual Reality Compared to Nitrous Oxide for Labor Analgesia

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University School of Medicine

Stanford, California, 94305, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Drug

30 min exposure for labor analgesia

Primary outcomes

  1. Patient satisfaction

    Time frame: 70 minutes

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

Secondary outcomes

  1. Pain score

    Time frame: 70 minutes

    Pain level on a scale of 0-10

  2. Anxiety

    Time frame: 70 minutes

    Anxiety level on a scale of 0-10

  3. Nausea

    Time frame: 70 minutes

    Nausea level on a scale of 0-10

  4. Dizzy

    Time frame: 70 minutes

    Dizziness level on a scale of 0-10

  5. Effectiveness

    Time frame: 70 minutes

    Effectiveness of device in relieving pain on a scale of 0-10

  6. Cope with Pain

    Time frame: 70 minutes

    Ability to cope with pain on a scale of 0-10

Sponsors and collaborators

Lead sponsor

Brendan Carvalho

Other

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Feb 10, 2021
Registry last updated
Mar 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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