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Virtual Reality Analgesia in Labor: The VRAIL Pilot Study (VRAIL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02926469
Recruitment Status : Completed
First Posted : October 6, 2016
Last Update Posted : February 1, 2018
Sponsor:
Information provided by (Responsible Party):
Melissa Bauer, University of Michigan

Tracking Information
First Submitted Date  ICMJE September 14, 2016
First Posted Date  ICMJE October 6, 2016
Last Update Posted Date February 1, 2018
Actual Study Start Date  ICMJE October 25, 2016
Actual Primary Completion Date April 14, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 4, 2016)
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Virtual Reality Analgesia in Labor: The VRAIL Pilot Study
Official Title  ICMJE Virtual Reality Analgesia in Labor: The VRAIL Pilot Study
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Labor Pain
Intervention  ICMJE Device: Virtual Reality
Using Virtual Reality during labor
Study Arms  ICMJE
  • No Intervention: Standard Care
    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.
  • Experimental: 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.
    Intervention: Device: Virtual Reality
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 26, 2017)
28
Original Estimated Enrollment  ICMJE
 (submitted: October 4, 2016)
30
Actual Study Completion Date  ICMJE April 14, 2017
Actual Primary Completion Date April 14, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02926469
Other Study ID Numbers  ICMJE HUM00116129
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Melissa Bauer, University of Michigan
Study Sponsor  ICMJE University of Michigan
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Melissa Bauer, DO University of Michigan
PRS Account University of Michigan
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP