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Problems with recruitment
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Latent-Control | No Intervention | Patients in the latent phase of labor who will receive no intervention. | |
| Latent-Virtual Reality (VR) | Experimental | Patients in the latent phase of labor who will receive the Virtual Reality (VR) intervention. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual Reality device | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28356241 | Background | 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. | |
| 27349654 |
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No events occurred between recruitment, enrollment, and randomization/assignment to a study arm.
Enrollment began in March 2018 and completed in February 2019. Patients were recruited in the labor and delivery inpatient setting.
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| ID | Title | Description |
|---|---|---|
| FG000 | Latent-Control | Patients in the latent phase of labor who will receive no intervention. |
| FG001 | Latent-VR | Patients in the latent phase of labor who will receive the 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Active-Control and Active-VR participants were not recruited
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| ID | Title | Description |
|---|---|---|
| BG000 | Latent-Control | Patients in the latent phase of labor who will receive no intervention. |
| BG001 | Latent-VR | Patients in the latent phase of labor who will receive the 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Average Pain Score in 2 hours AFTER Intervention data available only for 9/19 Latent-Control participants and 14/21 Latent-VR participants Average Pain Score in 4 hours AFTER Intervention data available only for 7/19 Latent-Control participants and 12/21 Latent-VR participants Average Pain Score in 24 hours AFTER Intervention data available only for 0/19 Latent-Control participants and 2/21 Latent-VR participants | Posted | Mean | Full Range | score on a scale | 4 hours prior to intervention, immediately pre-intervention, immediately post-intervention, 2, 4, 24 hours post-intervention |
|
6 weeks
0 participants in Active-Control group and 0 participants Active-VR group. Participants were not recruited into these two groups.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Latent-Control | Patients in the latent phase of labor who will receive no intervention. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Melissa Wong, MD MHDS | Cedars Sinai | 310-423-0895 | wongmsx@cshs.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 25, 2021 | Jun 25, 2021 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D048949 | Labor Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Parallel randomized controlled trials
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|
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) |
| 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Gravidity | Mean | Full Range | pregnancies |
|
| Parity | Mean | Full Range | pregnancies |
|
| Insurance | Count of Participants | Participants |
|
| BMI | Mean | Full Range | kg/m^2 |
|
| OG001 | Latent-VR | Patients in the latent phase of labor who will receive the 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. |
|
|
| Secondary | Number of Participants With a Need for Intravenous Pain Medication | IV pain medication during the intervention (yes/no) | Posted | Count of Participants | Participants | The total duration of the intervention (30 minutes) |
|
|
|
| Secondary | Need for Epidural During the Intervention | Number of participants with need for an epidural during the intervention | Posted | Count of Participants | Participants | The total duration of the intervention (30 minutes) |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | 30 minutes |
|
|
|
| Secondary | Number of Participants With a Need for Epidural During the Labor | Epidural use during labor (yes/no) | Posted | Count of Participants | Participants | The total duration of the patient's labor (average 24 hours) |
|
|
|
| 0 |
| 19 |
| 0 |
| 19 |
| 0 |
| 19 |
| EG001 | Latent-VR | Patients in the latent phase of labor who will receive the 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. | 0 | 21 | 0 | 21 | 0 | 21 |
| EG002 | Active-Control | Patients in the active phase of labor who will receive no intervention. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG003 | Active-VR | Patients in the active phase of labor who will receive the 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. | 0 | 0 | 0 | 0 | 0 | 0 |
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