Virtual Reality in Labor and Delivery for Reduction in Pain
NCT ID: NCT03437031
Last Updated: 2021-11-26
Study Results
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View full resultsBasic Information
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TERMINATED
NA
40 participants
INTERVENTIONAL
2018-03-01
2019-02-19
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Latent-Control
Patients in the latent phase of labor who will receive no intervention.
No interventions assigned to this group
Latent-Virtual Reality (VR)
Patients in the latent phase of labor who will receive the Virtual Reality (VR) intervention.
Virtual Reality device
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.
Interventions
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Virtual Reality device
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.
Eligibility Criteria
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Inclusion Criteria
2. \>18 years old
3. Pregnant with term gestation
4. Nullipara
5. Pain due to contractions rated from 4-7
6. Contractions at least every 5 minutes x 30 minutes preceding
7. Pain scores obtained at least every 60 minutes
Exclusion Criteria
2. Use of intravenous medications for pain relief prior to the intervention
3. Use of an epidural
4. Preterm gestation
5. Pain not due to contractions
6. Pain score of 3 or below or 8 or above
18 Years
FEMALE
Yes
Sponsors
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Cedars-Sinai Medical Center
OTHER
Responsible Party
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Kimberly Gregory
Professor
Locations
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Cedars-Sinai Medical Center
Los Angeles, California, United States
Countries
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References
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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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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Pro00050082
Identifier Type: -
Identifier Source: org_study_id