Trial Outcomes & Findings for Virtual Reality in Labor and Delivery for Reduction in Pain (NCT NCT03437031)
NCT ID: NCT03437031
Last Updated: 2021-11-26
Results Overview
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.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
4 hours prior to intervention, immediately pre-intervention, immediately post-intervention, 2, 4, 24 hours post-intervention
Results posted on
2021-11-26
Participant Flow
Enrollment began in March 2018 and completed in February 2019. Patients were recruited in the labor and delivery inpatient setting.
No events occurred between recruitment, enrollment, and randomization/assignment to a study arm.
Participant milestones
| Measure |
Latent-Control
Patients in the latent phase of labor who will receive no intervention.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
21
|
|
Overall Study
COMPLETED
|
19
|
21
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Virtual Reality in Labor and Delivery for Reduction in Pain
Baseline characteristics by cohort
| Measure |
Latent-Control
n=19 Participants
Patients in the latent phase of labor who will receive no intervention.
|
Latent-VR
n=21 Participants
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
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
32.47 years
n=5 Participants
|
31.57 years
n=7 Participants
|
32 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Gravidity
|
1.16 pregnancies
n=5 Participants
|
1.29 pregnancies
n=7 Participants
|
1.23 pregnancies
n=5 Participants
|
|
Parity
|
0 pregnancies
n=5 Participants
|
0 pregnancies
n=7 Participants
|
0 pregnancies
n=5 Participants
|
|
Insurance
HMO / Managed Care
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Insurance
Medicaid
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Insurance
Private
|
18 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Insurance
Self-pay / None
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
BMI
|
27.29 kg/m^2
n=5 Participants
|
30.11 kg/m^2
n=7 Participants
|
28.77 kg/m^2
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 hours prior to intervention, immediately pre-intervention, immediately post-intervention, 2, 4, 24 hours post-interventionPopulation: 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
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.
Outcome measures
| Measure |
Latent-Control
n=19 Participants
Patients in the latent phase of labor who will receive no intervention.
|
Latent-VR
n=21 Participants
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.
|
|---|---|---|
|
Reduction in Pain
Average Pain Score in 4 hours PRIOR to Intervention
|
3.39 score on a scale
Interval 0.0 to 7.0
|
4.52 score on a scale
Interval 1.3 to 7.0
|
|
Reduction in Pain
Pre-Intervention Pain score
|
5.05 score on a scale
Interval 4.0 to 7.0
|
6 score on a scale
Interval 4.0 to 7.0
|
|
Reduction in Pain
Post-Intervention Pain score
|
5.63 score on a scale
Interval 4.0 to 10.0
|
5.48 score on a scale
Interval 0.0 to 8.0
|
|
Reduction in Pain
Average Pain Score in 2 hours AFTER Intervention
|
5.44 score on a scale
Interval 4.0 to 7.5
|
5 score on a scale
Interval 0.0 to 8.0
|
|
Reduction in Pain
Average Pain Score in 4 hours AFTER Intervention
|
6.2 score on a scale
Interval 4.3 to 8.7
|
5.48 score on a scale
Interval 1.0 to 8.5
|
|
Reduction in Pain
Average Pain Score in 24 hours AFTER Intervention
|
—
|
3.36 score on a scale
Interval 2.75 to 4.0
|
SECONDARY outcome
Timeframe: The total duration of the intervention (30 minutes)IV pain medication during the intervention (yes/no)
Outcome measures
| Measure |
Latent-Control
n=19 Participants
Patients in the latent phase of labor who will receive no intervention.
|
Latent-VR
n=21 Participants
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.
|
|---|---|---|
|
Number of Participants With a Need for Intravenous Pain Medication
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: The total duration of the intervention (30 minutes)Number of participants with need for an epidural during the intervention
Outcome measures
| Measure |
Latent-Control
n=19 Participants
Patients in the latent phase of labor who will receive no intervention.
|
Latent-VR
n=21 Participants
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.
|
|---|---|---|
|
Need for Epidural During the Intervention
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 30 minutesThe 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.
Outcome measures
| Measure |
Latent-Control
n=19 Participants
Patients in the latent phase of labor who will receive no intervention.
|
Latent-VR
n=21 Participants
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.
|
|---|---|---|
|
Childbirth Self-Efficacy Inventory
|
54.8 score on a scale
Standard Deviation 11.2
|
52.6 score on a scale
Standard Deviation 11.8
|
SECONDARY outcome
Timeframe: The total duration of the patient's labor (average 24 hours)Epidural use during labor (yes/no)
Outcome measures
| Measure |
Latent-Control
n=19 Participants
Patients in the latent phase of labor who will receive no intervention.
|
Latent-VR
n=21 Participants
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.
|
|---|---|---|
|
Number of Participants With a Need for Epidural During the Labor
|
17 Participants
|
18 Participants
|
Adverse Events
Latent-Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Latent-VR
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Active-Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Active-VR
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place