Virtual Reality in Labor and Delivery for Reduction in Pain
Primary Purpose
Labor Pain, Virtual Reality, Alternative Medicine
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Virtual Reality device
Sponsored by
About this trial
This is an interventional treatment trial for Labor Pain focused on measuring Labor Pain, Virtual Reality, Alternative Medicine
Eligibility Criteria
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
Sites / Locations
- Cedars-Sinai Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Latent-Control
Latent-Virtual Reality (VR)
Arm Description
Patients in the latent phase of labor who will receive no intervention.
Patients in the latent phase of labor who will receive the Virtual Reality (VR) intervention.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Number of Participants With a Need for Intravenous Pain Medication
IV pain medication during the intervention (yes/no)
Need for Epidural During the Intervention
Number of participants with need for an epidural during the intervention
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.
Number of Participants With a Need for Epidural During the Labor
Epidural use during labor (yes/no)
Full Information
NCT ID
NCT03437031
First Posted
January 16, 2018
Last Updated
October 29, 2021
Sponsor
Cedars-Sinai Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03437031
Brief Title
Virtual Reality in Labor and Delivery for Reduction in Pain
Official Title
Virtual Reality in Labor and Delivery for Reduction in Pain
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Terminated
Why Stopped
Problems with recruitment
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
February 19, 2019 (Actual)
Study Completion Date
February 19, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cedars-Sinai Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Labor Pain, Virtual Reality, Alternative Medicine
Keywords
Labor Pain, Virtual Reality, Alternative Medicine
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel randomized controlled trials
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Latent-Control
Arm Type
No Intervention
Arm Description
Patients in the latent phase of labor who will receive no intervention.
Arm Title
Latent-Virtual Reality (VR)
Arm Type
Experimental
Arm Description
Patients in the latent phase of labor who will receive the Virtual Reality (VR) intervention.
Intervention Type
Device
Intervention Name(s)
Virtual Reality device
Intervention Description
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.
Primary Outcome Measure Information:
Title
Reduction in Pain
Description
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.
Time Frame
4 hours prior to intervention, immediately pre-intervention, immediately post-intervention, 2, 4, 24 hours post-intervention
Secondary Outcome Measure Information:
Title
Number of Participants With a Need for Intravenous Pain Medication
Description
IV pain medication during the intervention (yes/no)
Time Frame
The total duration of the intervention (30 minutes)
Title
Need for Epidural During the Intervention
Description
Number of participants with need for an epidural during the intervention
Time Frame
The total duration of the intervention (30 minutes)
Title
Childbirth Self-Efficacy Inventory
Description
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.
Time Frame
30 minutes
Title
Number of Participants With a Need for Epidural During the Labor
Description
Epidural use during labor (yes/no)
Time Frame
The total duration of the patient's labor (average 24 hours)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
28356241
Citation
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.
Results Reference
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PubMed Identifier
27349654
Citation
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.
Results Reference
background
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Virtual Reality in Labor and Delivery for Reduction in Pain
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