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

Primary Purpose

Labor Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Virtual Reality
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Labor Pain focused on measuring Virtual Reality, Analgesia, Immersive Virtual Reality, VR, Labor, Pain

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts 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

Sites / Locations

  • University of Michigan Von Voigtlander Women's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard Care

Virtual Reality

Arm 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.

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.

Outcomes

Primary Outcome Measures

Pain and Anxiety
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
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
Evaluate women's attitudes towards Virtual Reality use during labor through a satisfaction questionnaire.

Secondary Outcome Measures

Full Information

First Posted
September 14, 2016
Last Updated
January 30, 2018
Sponsor
University of Michigan
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1. Study Identification

Unique Protocol Identification Number
NCT02926469
Brief Title
Virtual Reality Analgesia in Labor: The VRAIL Pilot Study
Acronym
VRAIL
Official Title
Virtual Reality Analgesia in Labor: The VRAIL Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
October 25, 2016 (Actual)
Primary Completion Date
April 14, 2017 (Actual)
Study Completion Date
April 14, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Labor Pain
Keywords
Virtual Reality, Analgesia, Immersive Virtual Reality, VR, Labor, Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard Care
Arm Type
No Intervention
Arm 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.
Arm Title
Virtual Reality
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
Virtual Reality
Intervention Description
Using Virtual Reality during labor
Primary Outcome Measure Information:
Title
Pain and Anxiety
Description
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.
Time Frame
one time for the duration of one minute after 10 minutes of contractions with standard care
Title
Pain and Anxiety
Description
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.
Time Frame
one time for the duration of one minute after 10 minutes of contractions using Virtual Reality
Title
Satisfaction
Description
Evaluate women's attitudes towards Virtual Reality use during labor through a satisfaction questionnaire.
Time Frame
one time for the duration of one minute after using Virtual Reality

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melissa Bauer, DO
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan Von Voigtlander Women's Hospital
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31094789
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.
Results Reference
derived

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Virtual Reality Analgesia in Labor: The VRAIL Pilot Study

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