Virtual Reality in Labor and Delivery for Reduction in Pain
Study Details
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
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 Design
Arms and Interventions
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. |
Device: 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.
|
Outcome Measures
Primary Outcome Measures
- Reduction in Pain [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.
Secondary Outcome Measures
- Number of Participants With a Need for Intravenous Pain Medication [The total duration of the intervention (30 minutes)]
IV pain medication during the intervention (yes/no)
- Need for Epidural During the Intervention [The total duration of the intervention (30 minutes)]
Number of participants with need for an epidural during the intervention
- Childbirth Self-Efficacy Inventory [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.
- Number of Participants With a Need for Epidural During the Labor [The total duration of the patient's labor (average 24 hours)]
Epidural use during labor (yes/no)
Eligibility Criteria
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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Cedars-Sinai Medical Center | Los Angeles | California | United States | 90048 |
Sponsors and Collaborators
- Cedars-Sinai Medical Center
Investigators
None specified.Study Documents (Full-Text)
More Information
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.
- Pro00050082
Study Results
Participant Flow
Recruitment Details | Enrollment began in March 2018 and completed in February 2019. Patients were recruited in the labor and delivery inpatient setting. |
---|---|
Pre-assignment Detail | No events occurred between recruitment, enrollment, and randomization/assignment to a study arm. |
Arm/Group Title | Latent-Control | Latent-VR |
---|---|---|
Arm/Group Description | Patients in the latent phase of labor who will receive no intervention. | 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. |
Period Title: Overall Study | ||
STARTED | 19 | 21 |
COMPLETED | 19 | 21 |
NOT COMPLETED | 0 | 0 |
Baseline Characteristics
Arm/Group Title | Latent-Control | Latent-VR | Total |
---|---|---|---|
Arm/Group Description | Patients in the latent phase of labor who will receive no intervention. | 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. | Total of all reporting groups |
Overall Participants | 19 | 21 | 40 |
Age (years) [Mean (Full Range) ] | |||
Mean (Full Range) [years] |
32.47
|
31.57
|
32
|
Sex: Female, Male (Count of Participants) | |||
Female |
19
100%
|
21
100%
|
40
100%
|
Male |
0
0%
|
0
0%
|
0
0%
|
Ethnicity (NIH/OMB) (Count of Participants) | |||
Hispanic or Latino |
1
5.3%
|
6
28.6%
|
7
17.5%
|
Not Hispanic or Latino |
18
94.7%
|
15
71.4%
|
33
82.5%
|
Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
Race (NIH/OMB) (Count of Participants) | |||
American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
Asian |
0
0%
|
1
4.8%
|
1
2.5%
|
Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
Black or African American |
2
10.5%
|
2
9.5%
|
4
10%
|
White |
17
89.5%
|
14
66.7%
|
31
77.5%
|
More than one race |
0
0%
|
0
0%
|
0
0%
|
Unknown or Not Reported |
0
0%
|
4
19%
|
4
10%
|
Gravidity (pregnancies) [Mean (Full Range) ] | |||
Mean (Full Range) [pregnancies] |
1.16
|
1.29
|
1.23
|
Parity (pregnancies) [Mean (Full Range) ] | |||
Mean (Full Range) [pregnancies] |
0
|
0
|
0
|
Insurance (Count of Participants) | |||
HMO / Managed Care |
0
0%
|
4
19%
|
4
10%
|
Medicaid |
1
5.3%
|
2
9.5%
|
3
7.5%
|
Private |
18
94.7%
|
14
66.7%
|
32
80%
|
Self-pay / None |
0
0%
|
1
4.8%
|
1
2.5%
|
BMI (kg/m^2) [Mean (Full Range) ] | |||
Mean (Full Range) [kg/m^2] |
27.29
|
30.11
|
28.77
|
Outcome Measures
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 |
Outcome Measure Data
Analysis Population Description |
---|
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 |
Arm/Group Title | Latent-Control | Latent-VR |
---|---|---|
Arm/Group Description | Patients in the latent phase of labor who will receive no intervention. | 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. |
Measure Participants | 19 | 21 |
Average Pain Score in 4 hours PRIOR to Intervention |
3.39
|
4.52
|
Pre-Intervention Pain score |
5.05
|
6
|
Post-Intervention Pain score |
5.63
|
5.48
|
Average Pain Score in 2 hours AFTER Intervention |
5.44
|
5
|
Average Pain Score in 4 hours AFTER Intervention |
6.2
|
5.48
|
Average Pain Score in 24 hours AFTER Intervention |
3.36
|
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) |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Latent-Control | Latent-VR |
---|---|---|
Arm/Group Description | Patients in the latent phase of labor who will receive no intervention. | 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. |
Measure Participants | 19 | 21 |
Count of Participants [Participants] |
0
0%
|
0
0%
|
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) |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Latent-Control | Latent-VR |
---|---|---|
Arm/Group Description | Patients in the latent phase of labor who will receive no intervention. | 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. |
Measure Participants | 19 | 21 |
Count of Participants [Participants] |
0
0%
|
0
0%
|
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 |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Latent-Control | Latent-VR |
---|---|---|
Arm/Group Description | Patients in the latent phase of labor who will receive no intervention. | 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. |
Measure Participants | 19 | 21 |
Mean (Standard Deviation) [score on a scale] |
54.8
(11.2)
|
52.6
(11.8)
|
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) |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Latent-Control | Latent-VR |
---|---|---|
Arm/Group Description | Patients in the latent phase of labor who will receive no intervention. | 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. |
Measure Participants | 19 | 21 |
Count of Participants [Participants] |
17
89.5%
|
18
85.7%
|
Adverse Events
Time Frame | 6 weeks | |||||||
---|---|---|---|---|---|---|---|---|
Adverse Event Reporting Description | 0 participants in Active-Control group and 0 participants Active-VR group. Participants were not recruited into these two groups. | |||||||
Arm/Group Title | Latent-Control | Latent-VR | Active-Control | Active-VR | ||||
Arm/Group Description | Patients in the latent phase of labor who will receive no intervention. | 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. | Patients in the active phase of labor who will receive no intervention. | 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. | ||||
All Cause Mortality |
||||||||
Latent-Control | Latent-VR | Active-Control | Active-VR | |||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/19 (0%) | 0/21 (0%) | 0/0 (NaN) | 0/0 (NaN) | ||||
Serious Adverse Events |
||||||||
Latent-Control | Latent-VR | Active-Control | Active-VR | |||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/19 (0%) | 0/21 (0%) | 0/0 (NaN) | 0/0 (NaN) | ||||
Other (Not Including Serious) Adverse Events |
||||||||
Latent-Control | Latent-VR | Active-Control | Active-VR | |||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/19 (0%) | 0/21 (0%) | 0/0 (NaN) | 0/0 (NaN) |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title | Melissa Wong, MD MHDS |
---|---|
Organization | Cedars Sinai |
Phone | 310-423-0895 |
wongmsx@cshs.org |
- Pro00050082