Virtual Reality Analgesia in Labor: The VRAIL Pilot Study

Study Overview
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Brief Summary
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The purpose of the proposed study is to evaluate the feasibility of using immersive Virtual Reality (VR) during labor. We will also explore whether VR distraction is helpful for reducing subjective pain during labor, even if this pain is severe or excruciating. We predict that VR is feasible in this setting and that VR distraction will reduce acute pain and anxiety during labor.

Detailed Description
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This study used an over the counter consumer product to create a virtual reality experience so that we could assess whether there was a decrease in perception of pain.

Official Title
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Virtual Reality Analgesia in Labor: The VRAIL Pilot Study

Conditions
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Labor Pain

Intervention / Treatment
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* Device: Virtual Reality


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Any woman giving birth for the first time at or after 32 weeks Low risk pregnancy without obstetric complications In first stage of labor for vaginal delivery Desires non-pharmacologic alternative for pain control Exclusion Criteria: Younger than 18 or older than 45 years of age Presence of fetal or placental anomaly High risk pregnancy or anesthetic concerns (BMI>40, difficult airway, hemorrhage, nonreassuring FHR, malpresentation) Current use of pharmacologic analgesia including neuraxial anesthesia Not capable of answering study measures using numeric rating scale Any face/head/neck injuries that interfere with the use of Virtual Reality equipment Any form of contact precautions Severe hearing or vision deficits Susceptibility to motion sickness Seizure history History of psychiatric disorder, chronic pain, migraines, or addiction Delirium, psychosis, any form of developmental delay, or Organic Brain Disorder Requiring an interpreter for communication

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard Care<br>For patients presenting in labor and desiring standard care (natural childbirth without pain medications, systematic distraction, or alternative therapies) the patient will experience their contractions. Afterwards they will answer pain and anxiety questionnaires. | |
| Experimental: Virtual Reality<br>For patients presenting in labor and desiring standard care (natural childbirth without pain medications, systematic distraction, or alternative therapies) the patient will experience their contractions while using immersive Virtual Reality.Afterwards they will answer pain and anxiety questionnaires. | Device: Virtual Reality<br>* Using Virtual Reality during labor<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain and Anxiety | Pain is measured one time after 10 minutes of contractions with standard care, by asking the subjects about their pain and anxiety level, using a questionnaire called graphic rating scale. | one time for the duration of one minute after 10 minutes of contractions with standard care | 
| Pain and Anxiety | Pain is measured one time after 10 minutes of contractions with Virtual Reality, by asking the subjects about their pain and anxiety level, using a questionnaire called graphic rating scale. | one time for the duration of one minute after 10 minutes of contractions using Virtual Reality | 
| Satisfaction | Evaluate women's attitudes towards Virtual Reality use during labor through a satisfaction questionnaire. | one time for the duration of one minute after using Virtual Reality | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Virtual Reality, Analgesia, Immersive Virtual Reality, VR, Labor, Pain