- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03437031
Virtual Reality in Labor and Delivery for Reduction in Pain
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The purpose of this study is to identify whether use of virtual reality devices can improve the pain management of women in labor and delivery. The investigators hypothesize that use of virtual reality devices will result in a reduction in pain medication use, in epidural use, and prolong the duration of time prior to the patient receiving an epidural.
The study will be conducted as two parallel randomized controlled trials: one for latent labor patients and one for patients in active labor (defined by whether they are < 6 cm or > 6 cm). Within each phase of labor, there will be 20 in the Virtual Reality arm and 20 in the Control arm for a total of 80 patients.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
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Los Angeles, California, United States, 90048
- Cedars-Sinai Medical Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Female
- >18 years old
- Pregnant with term gestation
- Nullipara
- Pain due to contractions rated from 4-7
- Contractions at least every 5 minutes x 30 minutes preceding
- Pain scores obtained at least every 60 minutes
Exclusion Criteria:
- Parous
- Use of intravenous medications for pain relief prior to the intervention
- Use of an epidural
- Preterm gestation
- Pain not due to contractions
- Pain score of 3 or below or 8 or above
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Latent-Control
Patients in the latent phase of labor who will receive no intervention.
|
|
Experimental: Latent-Virtual Reality (VR)
Patients in the latent phase of labor who will receive the Virtual Reality (VR) intervention.
|
For those patients randomized to VR, the study staff member will explain the use of the Samsung VR goggle set, and thereafter will allow the patient to use the device freely for up to 30 minutes.
Intervals of 2-5 minutes is suggested for first-time use, and patients will be to allowed to discontinue it at any time as long as they are not experiencing any discomfort or side effects (dizziness, motion sickness, etc.).
The study staff member will be present at all times, and will work with hospital staff as necessary to ensure the patient is receiving appropriate clinical care throughout the duration of the intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reduction in Pain
Time Frame: 4 hours prior to intervention, immediately pre-intervention, immediately post-intervention, 2, 4, 24 hours post-intervention
|
Difference in pain scores pre-post intervention compared to control.
The investigators will use the Visual Analog Scale (VAS) for Pain.
The minimum pain is 1; the maximum is 10.
Higher values represent more pain.
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4 hours prior to intervention, immediately pre-intervention, immediately post-intervention, 2, 4, 24 hours post-intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With a Need for Intravenous Pain Medication
Time Frame: The total duration of the intervention (30 minutes)
|
IV pain medication during the intervention (yes/no)
|
The total duration of the intervention (30 minutes)
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Need for Epidural During the Intervention
Time Frame: The total duration of the intervention (30 minutes)
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Number of participants with need for an epidural during the intervention
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The total duration of the intervention (30 minutes)
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Childbirth Self-Efficacy Inventory
Time Frame: 30 minutes
|
The Childbirth Self-Efficacy Inventory (CSEI) is a measure of how well a patient anticipates being able to perform certain tasks in labor such as relaxing their body, keeping calm, or not thinking about the pain.
The investigators will ask to what extend they feel virtual reality would be able to influence their ability to do these things.
A fifteen-question scale reflecting degree of control where 1 is least control and 5 is most control per item.
Minimum score 15 reflecting least total control; maximum score 75 reflecting maximal control.
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30 minutes
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Number of Participants With a Need for Epidural During the Labor
Time Frame: The total duration of the patient's labor (average 24 hours)
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Epidural use during labor (yes/no)
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The total duration of the patient's labor (average 24 hours)
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Mosadeghi S, Reid MW, Martinez B, Rosen BT, Spiegel BM. Feasibility of an Immersive Virtual Reality Intervention for Hospitalized Patients: An Observational Cohort Study. JMIR Ment Health. 2016 Jun 27;3(2):e28. doi: 10.2196/mental.5801.
- Tashjian VC, Mosadeghi S, Howard AR, Lopez M, Dupuy T, Reid M, Martinez B, Ahmed S, Dailey F, Robbins K, Rosen B, Fuller G, Danovitch I, IsHak W, Spiegel B. Virtual Reality for Management of Pain in Hospitalized Patients: Results of a Controlled Trial. JMIR Ment Health. 2017 Mar 29;4(1):e9. doi: 10.2196/mental.7387.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00050082
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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