Virtual Reality Compared to Nitrous Oxide for Labor Analgesia

Labor Pain Clinical Trial

Official title:

Virtual Reality Compared to Nitrous Oxide for Labor Analgesia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04749043
• Other study ID #: 59344
• Status: Completed
• Phase: N/A
• Start date: February 18, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2024
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Labor Pain

Intervention

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

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Brendan Carvalho

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient satisfaction	Patient satisfaction with pain relief on a scale of 0-10	70 minutes
Secondary	Pain score	Pain level on a scale of 0-10	70 minutes
Secondary	Anxiety	Anxiety level on a scale of 0-10	70 minutes
Secondary	Nausea	Nausea level on a scale of 0-10	70 minutes
Secondary	Dizzy	Dizziness level on a scale of 0-10	70 minutes
Secondary	Effectiveness	Effectiveness of device in relieving pain on a scale of 0-10	70 minutes
Secondary	Cope with Pain	Ability to cope with pain on a scale of 0-10	70 minutes