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Virtual Reality Analgesia in Labor: The VRAIL Pilot Study

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University of Michigan

Status

Completed

Conditions

Labor Pain

Treatments

Device: Virtual Reality

Study type

Interventional

Funder types

Other

Identifiers

NCT02926469
HUM00116129

Details and patient eligibility

About

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.

Full 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.

Enrollment

28 patients

Sex

Female

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

28 participants in 2 patient groups

Standard Care
No Intervention group
Description:
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.
Virtual Reality
Experimental group
Description:
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.
Treatment:
Device: Virtual Reality

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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