Labor PainNCT04749043
Virtual Reality Compared to Nitrous Oxide for Labor Analgesia
A study testing Oculus Quest 2 Virtual Reality Device and Nitrous oxide in people with Labor Pain, run by Brendan Carvalho at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor Pain
- What is being tested?
- Oculus Quest 2 Virtual Reality Device and Nitrous oxide
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Feb 2021to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Singleton pregnancy at >34 weeks
- Regular uterine contractions
- Pain > 2/10
- English speaking
Who cannot join
- BMI > 40
- Preeclampsia with severe features
- Use of IV analgesics during labor
- Diabetes requiring insulin therapy
- Claustrophobia
- History of epilepsy
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
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.
Read the 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.
- Conditions
- Labor Pain
- Being tested
- Oculus Quest 2 Virtual Reality Device, Nitrous oxide
- Keywords
- Virtual Reality
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oculus Quest 2 Virtual Reality DeviceDevice
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 oxideDrug
30 min exposure for labor analgesia
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality then Nitrous Oxide | Active comparator | 30 minute exposure to virtual reality, 5 minute washout period, then 30 minute exposure to nitrous oxide Receives: Device: Oculus Quest 2 Virtual Reality Device; Drug: Nitrous oxide |
| Nitrous Oxide then Virtual Reality | Active comparator | 30 minute exposure to nitrous oxide, 5 minute washout period, then 30 minute exposure to virtual reality Receives: Device: Oculus Quest 2 Virtual Reality Device; Drug: Nitrous oxide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient satisfaction
Patient satisfaction with pain relief on a scale of 0-10
Measured: 70 minutes
Secondary outcomes (6)
Pain score
Pain level on a scale of 0-10
Measured: 70 minutes
Anxiety
Anxiety level on a scale of 0-10
Measured: 70 minutes
Nausea
Nausea level on a scale of 0-10
Measured: 70 minutes
Dizzy
Dizziness level on a scale of 0-10
Measured: 70 minutes
Effectiveness
Effectiveness of device in relieving pain on a scale of 0-10
Measured: 70 minutes
Cope with Pain
Ability to cope with pain on a scale of 0-10
Measured: 70 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2021
- Study start18 Feb 2021
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labor PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brendan Carvalho
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Brendan Carvalho, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04749043
- Sponsor's protocol ID
- 59344
- Status last verified
- Mar 2024
- First submitted
- 2 Feb 2021
- Last updated
- 18 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality Compared to Nitrous Oxide for Labor Analgesia
- ClinicalTrials.gov ID
- NCT04749043
- Acronym / sponsor ID
- 59344
- Conditions
- Labor Pain
- Keywords
- Virtual Reality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Brendan CarvalhoUniversity, hospital or other
- Study start
- 18 Feb 2021 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 10 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality then Nitrous Oxide | Active comparator | Device: Oculus Quest 2 Virtual Reality Device, Drug: Nitrous oxide30 minute exposure to virtual reality, 5 minute washout period, then 30 minute exposure to nitrous oxide |
| Nitrous Oxide then Virtual Reality | Active comparator | Device: Oculus Quest 2 Virtual Reality Device, Drug: Nitrous oxide30 minute exposure to nitrous oxide, 5 minute washout period, then 30 minute exposure to virtual reality |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Singleton pregnancy at >34 weeks
- Regular uterine contractions
- Pain > 2/10
- English speaking
Key exclusion criteria (6 listed)
- BMI > 40
- Preeclampsia with severe features
- Use of IV analgesics during labor
- Diabetes requiring insulin therapy
- Claustrophobia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oculus Quest 2 Virtual Reality Device30 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 | Device | Nitrous Oxide then Virtual Reality, Virtual Reality then Nitrous Oxide |
| Nitrous oxide30 min exposure for labor analgesia | Drug | Nitrous Oxide then Virtual Reality, Virtual Reality then Nitrous Oxide |
Primary outcome
Patient satisfaction
Time frame: 70 minutes
Patient satisfaction with pain relief on a scale of 0-10
6 secondary outcomes
Pain score
Time frame: 70 minutes
Anxiety
Time frame: 70 minutes
Nausea
Time frame: 70 minutes
Dizzy
Time frame: 70 minutes
Effectiveness
Time frame: 70 minutes
Cope with Pain
Time frame: 70 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oculus Quest 2 Virtual Reality Device and Nitrous oxide in people with Labor Pain, run by Brendan Carvalho at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient satisfaction (time frame: 70 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2024.