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Virtual Reality vs. Nitrous Oxide for Labor Pain
N/A
Waitlist Available
Research Sponsored by Brendan Carvalho
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 70 minutes
Awards & highlights
Study Summary
This trial will compare the use of VR headsets to nitrous oxide for pain relief during labor for mothers who don't want epidural anesthesia.
Who is the study for?
This trial is for English-speaking individuals in labor with a single baby at over 34 weeks, experiencing moderate pain (more than 2/10). They should be having regular contractions and want non-epidural pain relief. It's not for those with severe preeclampsia, BMI over 40, insulin-treated diabetes, claustrophobia, epilepsy or who have used IV analgesics during labor.Check my eligibility
What is being tested?
The study is testing if Virtual Reality headsets using Oculus Quest 2 can provide similar pain relief to nitrous oxide gas during labor. Participants will either receive the VR device or nitrous oxide to manage their pain without an epidural.See study design
What are the potential side effects?
Nitrous oxide may cause nausea, dizziness, and sedation. The VR experience might lead to motion sickness or disorientation but typically has fewer physical side effects.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 70 minutes
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~70 minutes
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Patient satisfaction
Secondary outcome measures
Anxiety
Cope with Pain
Dizzy
+3 moreTrial Design
2Treatment groups
Active Control
Group I: Nitrous Oxide then Virtual RealityActive Control2 Interventions
30 minute exposure to nitrous oxide, 5 minute washout period, then 30 minute exposure to virtual reality
Group II: Virtual Reality then Nitrous OxideActive Control2 Interventions
30 minute exposure to virtual reality, 5 minute washout period, then 30 minute exposure to nitrous oxide
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Who is running the clinical trial?
Brendan CarvalhoLead Sponsor
1 Previous Clinical Trials
50 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have pain rated higher than 2 out of 10.You have a body mass index (BMI) higher than 40.You have a severe form of preeclampsia.You received pain medication through an IV during childbirth.You are experiencing regular contractions in your uterus.You have diabetes and need to take insulin.You are afraid of being in small or enclosed spaces.You have had seizures in the past.You are pregnant with only one baby and are at more than 34 weeks of pregnancy.
Research Study Groups:
This trial has the following groups:- Group 1: Nitrous Oxide then Virtual Reality
- Group 2: Virtual Reality then Nitrous Oxide
Awards:
This trial has 2 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the participant capacity of this research effort?
"Affirmative. Clinicaltrials.gov shows that this experiment, which was first posted on February 18th 2021, is currently recruiting participants. The team needs to enlist 60 individuals from one medical centre."
Answered by AI
Are there currently any opportunities for participants to join this experiment?
"Affirmative. Clinicaltrials.gov provides evidence that this study, initially published on February 18th 2021 is actively searching for 60 volunteers from one medical centre. The trial was most recently updated on October 24th 2022."
Answered by AI
What other investigations have been conducted that combine Virtual Reality and Nitrous Oxide?
"Currently, there are 12 distinct clinical trials being conducted to explore the effects of Virtual Reality and Nitrous Oxide. One is in Phase 3, while the other 11 are based out of Saint Louis, Missouri."
Answered by AI
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