Virtual Reality Compared to Nitrous Oxide for Labor Analgesia

Study Overview
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Brief Summary
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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
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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.

Official Title
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Virtual Reality Compared to Nitrous Oxide for Labor Analgesia

Conditions
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Labor Pain

Intervention / Treatment
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* Device: Oculus Quest 2 Virtual Reality Device
* Drug: Nitrous oxide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Virtual Reality then Nitrous Oxide<br>30 minute exposure to virtual reality, 5 minute washout period, then 30 minute exposure to nitrous oxide | Device: Oculus Quest 2 Virtual Reality Device<br>* 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<br>Drug: Nitrous oxide<br>* 30 min exposure for labor analgesia<br>|
| Active Comparator: Nitrous Oxide then Virtual Reality<br>30 minute exposure to nitrous oxide, 5 minute washout period, then 30 minute exposure to virtual reality | Device: Oculus Quest 2 Virtual Reality Device<br>* 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<br>Drug: Nitrous oxide<br>* 30 min exposure for labor analgesia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction | Patient satisfaction with pain relief on a scale of 0-10 | 70 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score | Pain level on a scale of 0-10 | 70 minutes | 
| Anxiety | Anxiety level on a scale of 0-10 | 70 minutes | 
| Nausea | Nausea level on a scale of 0-10 | 70 minutes | 
| Dizzy | Dizziness level on a scale of 0-10 | 70 minutes | 
| Effectiveness | Effectiveness of device in relieving pain on a scale of 0-10 | 70 minutes | 
| Cope with Pain | Ability to cope with pain on a scale of 0-10 | 70 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Virtual Reality