Virtual Reality Analgesia in Labor: The VRAIL Pilot Study

NCT ID: NCT02926469

Last Updated: 2018-02-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-25
• Study Completion Date: 2017-04-14

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.

Conditions

Labor Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Virtual Reality

Intervention Type: DEVICE

Using Virtual Reality during labor

Interventions

Virtual Reality

Using Virtual Reality during labor

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Melissa Bauer

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Melissa Bauer, DO

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

University of Michigan Von Voigtlander Women's Hospital

Ann Arbor, Michigan, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 31094789 (View on PubMed)

Other Identifiers

HUM00116129

Identifier Type: -

Identifier Source: org_study_id