Virtual Reality Analgesia in Labor: The VRAIL Pilot Study

Labor Pain Clinical Trial

— VRAIL  

Official title:

Virtual Reality Analgesia in Labor: The VRAIL Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02926469
• Other study ID #: HUM00116129
• Status: Completed
• Phase: N/A
• First received: September 14, 2016
• Last updated: January 30, 2018
• Start date: October 25, 2016
• Est. completion date: April 14, 2017

Study information

• Verified date: January 2018
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. We predict that VR is feasible in this setting and that VR distraction will reduce acute pain and anxiety during labor.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: April 14, 2017
• Est. primary completion date: April 14, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Labor Pain

Intervention

Device:
• Virtual Reality
Using Virtual Reality during labor

Locations

Country	Name	City	State
United States	University of Michigan Von Voigtlander Women's Hospital	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	one time for the duration of one minute after 10 minutes of contractions with standard care
Primary	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.	one time for the duration of one minute after 10 minutes of contractions using Virtual Reality
Primary	Satisfaction	Evaluate women's attitudes towards Virtual Reality use during labor through a satisfaction questionnaire.	one time for the duration of one minute after using Virtual Reality