Clinical trial NCT02926469: Virtual Reality Analgesia in Labor: The VRAIL Pilot Study
Official title: Virtual Reality Analgesia in Labor: The VRAIL Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Labor Pain
Keywords: Virtual Reality
Analgesia
Immersive Virtual Reality
VR
Labor
Pain
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2016-10-06
Enrollment: 28
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain and Anxiety
timeFrame: one time for the duration of one minute after 10 minutes of contractions with standard care
measure: Pain and Anxiety
timeFrame: one time for the duration of one minute after 10 minutes of contractions using Virtual Reality
measure: Satisfaction
timeFrame: one time for the duration of one minute after using Virtual Reality
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Von Voigtlander Women's Hospital
state: Michigan
Study officials:
affiliation: University of Michigan
name: Melissa Bauer, DO
role: PRINCIPAL_INVESTIGATOR
References:
citation: Frey DP, Bauer ME, Bell CL, Low LK, Hassett AL, Cassidy RB, Boyer KD, Sharar SR. Virtual Reality Analgesia in Labor: The VRAIL Pilot Study-A Preliminary Randomized Controlled Trial Suggesting Benefit of Immersive Virtual Reality Analgesia in Unmedicated Laboring Women. Anesth Analg. 2019 Jun;128(6):e93-e96. doi: 10.1213/ANE.0000000000003649.