Back to resultsVirtual Reality Compared to Nitrous Oxide for Labor Analgesia
Primary Purpose
Labor Pain
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Oculus Quest 2 Virtual Reality Device
Nitrous oxide
Sponsored by
About this trial
This is an interventional treatment trial for Labor Pain focused on measuring Virtual Reality
Eligibility Criteria
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
Sites / Locations
- Stanford University School of MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Virtual Reality then Nitrous Oxide
Nitrous Oxide then Virtual Reality
Arm Description
30 minute exposure to virtual reality, 5 minute washout period, then 30 minute exposure to nitrous oxide
30 minute exposure to nitrous oxide, 5 minute washout period, then 30 minute exposure to virtual reality
Outcomes
Primary Outcome Measures
Patient satisfaction
Patient satisfaction with pain relief on a scale of 0-10
Secondary Outcome Measures
Pain score
Pain level on a scale of 0-10
Anxiety
Anxiety level on a scale of 0-10
Nausea
Nausea level on a scale of 0-10
Dizzy
Dizziness level on a scale of 0-10
Effectiveness
Effectiveness of device in relieving pain on a scale of 0-10
Cope with Pain
Ability to cope with pain on a scale of 0-10
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04749043
Brief Title
Virtual Reality Compared to Nitrous Oxide for Labor Analgesia
Official Title
Virtual Reality Compared to Nitrous Oxide for Labor Analgesia
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 18, 2021 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Brendan Carvalho
4. Oversight
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
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Labor Pain
Keywords
Virtual Reality
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Virtual Reality then Nitrous Oxide
Arm Type
Active Comparator
Arm Description
30 minute exposure to virtual reality, 5 minute washout period, then 30 minute exposure to nitrous oxide
Arm Title
Nitrous Oxide then Virtual Reality
Arm Type
Active Comparator
Arm Description
30 minute exposure to nitrous oxide, 5 minute washout period, then 30 minute exposure to virtual reality
Intervention Type
Device
Intervention Name(s)
Oculus Quest 2 Virtual Reality Device
Intervention Description
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
Drug
Intervention Name(s)
Nitrous oxide
Intervention Description
30 min exposure for labor analgesia
Primary Outcome Measure Information:
Title
Patient satisfaction
Description
Patient satisfaction with pain relief on a scale of 0-10
Time Frame
70 minutes
Secondary Outcome Measure Information:
Title
Pain score
Description
Pain level on a scale of 0-10
Time Frame
70 minutes
Title
Anxiety
Description
Anxiety level on a scale of 0-10
Time Frame
70 minutes
Title
Nausea
Description
Nausea level on a scale of 0-10
Time Frame
70 minutes
Title
Dizzy
Description
Dizziness level on a scale of 0-10
Time Frame
70 minutes
Title
Effectiveness
Description
Effectiveness of device in relieving pain on a scale of 0-10
Time Frame
70 minutes
Title
Cope with Pain
Description
Ability to cope with pain on a scale of 0-10
Time Frame
70 minutes
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brendan Carvalho
Phone
650-222-7967
Email
brendan.carvalho@stanford.edu
First Name & Middle Initial & Last Name & Degree
Brendan Carvalho
First Name & Middle Initial & Last Name & Degree
Dan Hoang
First Name & Middle Initial & Last Name & Degree
Nan Guo
12. IPD Sharing Statement
Plan to Share IPD
No
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Virtual Reality Compared to Nitrous Oxide for Labor Analgesia
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