Virtual Reality in Labor and Delivery for Reduction in Pain

Study Overview
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Brief Summary
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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 will perform a randomized controlled trial of patients in labor at Cedars-Sinai Medical Center.

Detailed Description
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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.

Official Title
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Virtual Reality in Labor and Delivery for Reduction in Pain

Conditions
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Labor Pain, Virtual Reality, Alternative Medicine

Intervention / Treatment
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* Device: Virtual Reality device


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel randomized controlled trials
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Latent-Control<br>Patients in the latent phase of labor who will receive no intervention. | |
| Experimental: Latent-Virtual Reality (VR)<br>Patients in the latent phase of labor who will receive the Virtual Reality (VR) intervention. | Device: Virtual Reality device<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in Pain | 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. | 4 hours prior to intervention, immediately pre-intervention, immediately post-intervention, 2, 4, 24 hours post-intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With a Need for Intravenous Pain Medication | IV pain medication during the intervention (yes/no) | The total duration of the intervention (30 minutes) | 
| Need for Epidural During the Intervention | Number of participants with need for an epidural during the intervention | The total duration of the intervention (30 minutes) | 
| Childbirth Self-Efficacy Inventory | 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. | 30 minutes | 
| Number of Participants With a Need for Epidural During the Labor | Epidural use during labor (yes/no) | The total duration of the patient's labor (average 24 hours) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Labor Pain, Virtual Reality, Alternative Medicine