Virtual Reality Analgesia in Labor: The VRAIL Pilot Study

University of Michigan28 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Labor Pain

Interventions

Virtual RealityDEVICE

Using Virtual Reality during labor

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University of Michigan Von Voigtlander Women's Hospital

Ann Arbor, Michigan, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: one time for the duration of one minute after using Virtual Reality

Data from ClinicalTrials.gov

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