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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02926469
First Posted: October 6, 2016
Last Update Posted: May 30, 2017
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.
Information provided by (Responsible Party):
David Frey, University of Michigan
September 14, 2016
October 6, 2016
May 30, 2017
October 2016
April 2017   (Final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT02926469 on ClinicalTrials.gov Archive Site
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Virtual Reality Analgesia in Labor: The VRAIL Pilot Study
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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Labor Pain
Device: Virtual Reality
Using Virtual Reality during labor
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
April 2017
April 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years to 45 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02926469
HUM00116129
No
Not Provided
Plan to Share IPD: No
David Frey, University of Michigan
University of Michigan
Not Provided
Principal Investigator: David Frey, DO University of Michigan
Principal Investigator: Melissa Bauer, DO University of Michigan
University of Michigan
May 2017

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