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Completed

NCT Number: NCT02926469

Virtual Reality Analgesia in Labor: The VRAIL Pilot Study

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.

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Key information

Conditions

Labor Pain Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan Von Voigtlander Women's Hospital

Ann Arbor, Michigan, 48109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Virtual reality

Device

Using Virtual Reality during labor

Primary outcomes

  1. Pain and Anxiety

    Time frame: one time for the duration of one minute after 10 minutes of contractions with standard care

    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.

  2. Pain and Anxiety

    Time frame: 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.

  3. Satisfaction

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Acronym: VRAIL

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Oct 6, 2016
Registry last updated
Feb 1, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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