Labor PainVRAILNCT02926469
Virtual Reality Analgesia in Labor: The VRAIL Pilot Study
A study testing Virtual Reality in people with Labor Pain, run by University of Michigan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor Pain
- What is being tested?
- Virtual Reality
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Oct 2016to 14 Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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 locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Von Voigtlander Women's Hospital
Ann Arbor, Michigan, 48109
About this 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.
Read the 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.
- Conditions
- Labor Pain
- Being tested
- Virtual Reality
- Keywords
- Virtual Reality, Analgesia, Immersive Virtual Reality, VR, Labor, Pain
- Medical subject headings
- Labor Pain, Agnosia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual RealityDevice
Using Virtual Reality during labor
| Study group | Role | What they receive |
|---|---|---|
| Standard Care | No intervention | 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 | 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. Receives: Device: Virtual Reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one time for the duration of one minute after 10 minutes of contractions with standard care
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.
Measured: one time for the duration of one minute after 10 minutes of contractions using Virtual Reality
Satisfaction
Evaluate women's attitudes towards Virtual Reality use during labor through a satisfaction questionnaire.
Measured: one time for the duration of one minute after using Virtual Reality
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2016 (estimated)
- Study start25 Oct 2016
- Primary completion14 Apr 2017
- Study completion14 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Labor PainStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melissa Bauer, University of Michigan
- Investigators
- Melissa Bauer, DO, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02926469
- Sponsor's protocol ID
- HUM00116129
- Acronym
- VRAIL
- Status last verified
- Jan 2018
- First submitted
- 14 Sep 2016
- Last updated
- 1 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 31094789
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality Analgesia in Labor: The VRAIL Pilot Study
- ClinicalTrials.gov ID
- NCT02926469
- Acronym / sponsor ID
- VRAIL / HUM00116129
- Conditions
- Labor Pain
- Keywords
- Virtual Reality, Analgesia, Immersive Virtual Reality, VR, Labor, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 25 Oct 2016 (actual)
- Primary completion
- 14 Apr 2017 (actual)
- Study completion
- 14 Apr 2017 (actual)
- First posted
- 6 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Care | No intervention | –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 | Device: Virtual RealityFor 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual RealityUsing Virtual Reality during labor | Device | Virtual Reality |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2018.
- Derived from this study: PubMed 31094789Frey 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melissa Bauer, DO principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality in people with Labor Pain, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain and Anxiety (time frame: one time for the duration of one minute after 10 minutes of contractions with standard care). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02926469, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2018.