Virtual Reality Compared to Nitrous Oxide for Labor Analgesia

• Sponsor: Brendan Carvalho (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04749043
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 21.4
• Patients Per Site Per Month: 2.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Labor Pain	Device: Oculus Quest 2 Virtual Reality Device; Drug: Nitrous oxide	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• 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 designComparing VR to an "active control" of nitrous oxide as a current standard of care for non-epidural analgesic in a crossover design
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Virtual Reality Compared to Nitrous Oxide for Labor Analgesia
• Actual Study Start Date: Feb 18, 2021
• Anticipated Primary Completion Date: Dec 1, 2022
• Anticipated Study Completion Date: Dec 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Patient satisfaction [70 minutes]

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

Secondary Outcome Measures

1. Pain score [70 minutes]

   Pain level on a scale of 0-10

2. Anxiety [70 minutes]

   Anxiety level on a scale of 0-10

3. Nausea [70 minutes]

   Nausea level on a scale of 0-10

4. Dizzy [70 minutes]

   Dizziness level on a scale of 0-10

5. Effectiveness [70 minutes]

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

6. Cope with Pain [70 minutes]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stanford University School of Medicine	Stanford	California	United States	94305

Sponsors and Collaborators

• Brendan Carvalho

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Brendan Carvalho, Chief, Division of Obstetric Anesthesia, Stanford University
• ClinicalTrials.gov Identifier: NCT04749043
• Other Study ID Numbers: 59344
• First Posted: Feb 10, 2021
• Last Update Posted: Jun 10, 2021
• Last Verified: Jun 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Keywords provided by Brendan Carvalho, Chief, Division of Obstetric Anesthesia, Stanford University: Virtual Reality
• Additional relevant MeSH terms: Labor Pain; Nitrous Oxide

Study Results

No Results Posted as of Jun 10, 2021