Virtual Reality Analgesia in Labor: The VRAIL Pilot Study

Not Applicable

Completed

• Conditions: Labor Pain
• Interventions: Device: Virtual Reality

• Registration Number: NCT02926469
• Lead Sponsor: University of Michigan

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2016-09-14
• Study First Submitted QC: 2016-10-04
• Study First Posted: 2016-10-06
• Study Start: 2016-10-25
• Primary Completion: 2017-04-14
• Study Completion: 2017-04-14
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-30
• Last Update Posted: 2018-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 28

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Virtual Reality	Virtual Reality	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.

Primary Outcome Measures

Name	Time	Method
Pain and Anxiety	one time for the duration of one minute after 10 minutes of contractions using Virtual Reality	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.
Satisfaction	one time for the duration of one minute after using Virtual Reality	Evaluate women's attitudes towards Virtual Reality use during labor through a satisfaction questionnaire.

Trial Locations

Locations (1)

University of Michigan Von Voigtlander Women's Hospital; 🇺🇸 Ann Arbor, Michigan, United States