This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Virtual Reality in Labor and Delivery for Reduction in Pain (NCT03437031), a randomized na study. The primary outcome is Reduction in Pain.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03437031 |
| Phase | NA |
| Condition | Labor Pain, Virtual Reality, Alternative Medicine |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 40 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Cedars-Sinai Medical Center |
| Results posted | Yes |
2. Clinical Question
Population
Patients in the latent phase of labor at Cedars-Sinai Medical Center were the population described for the two study arms. The trial’s brief summary describes patients in labor and delivery, while the arm descriptions specify the latent phase. The registry record lists enrollment as 40. It does not report further eligibility details, such as how the latent phase was defined or which patients were excluded.
Intervention
The intervention was a virtual reality device. The registry describes the Latent-VR arm as receiving the virtual reality intervention. It does not report details about the device, how it was used, the duration of use, or whether participants could use it alongside other pain-management options.
Comparator
The comparison was the Latent-Control arm, whose participants received no intervention. The registry also lists Active-Control and Active-VR groups, but records zero participants at risk in both; the described comparison concerns the latent-phase control and virtual reality arms.
Primary question
The primary question was whether pain scores changed differently before and after the intervention in the virtual reality arm compared with the control arm. Pain was measured using the Visual Analog Scale for Pain, with scores from 1 to 10 and higher values representing more pain. The registry describes measurements before, immediately after, and at later times following intervention. It does not report the pain-score results or an analysis comparing the arms, so the recorded information does not establish the direction or size of any difference.
3. Trial Design
The registry identifies NCT03437031 as a randomized, parallel-group trial with no masking. Its title is “Virtual Reality in Labor and Delivery for Reduction in Pain.” Cedars-Sinai Medical Center is listed as the sponsor, and the brief summary places the trial at Cedars-Sinai Medical Center. The listed phase is NA. Enrollment is recorded as 40.
The described arms are Latent-Control and Latent-Virtual Reality (VR). Participants in the control arm received no intervention; participants in the VR arm received the virtual reality intervention. The record also lists Active-Control and Active-VR groups, but each has zero participants at risk. The populated arm counts are 19 for Latent-Control and 21 for Latent-VR. These are the counts recorded for the adverse-event reporting groups; the registry does not explain how those counts relate to every outcome’s analysis population.
The study start date is 2018-03-01, and the primary completion date is 2019-02-19. The overall status is TERMINATED. The reason for termination and whether termination affected recruitment or follow-up are not reported in the registry record. The record does not state whether the study’s enrollment figure represents a planned or final count in a separate design description.
Randomization is intended to allocate participants to comparison groups in a way that can reduce systematic differences at assignment. In general, a parallel-group design assigns participants to one arm and compares outcomes across arms. No masking means the registry does not describe blinded assignment or assessment; further details of who knew each participant’s assignment are not reported in the registry record. The planned allocation procedure, sequence generation, and concealment details are also not reported in the registry record.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Before assignment: No events occurred between recruitment, enrollment, and randomization/assignment to a study arm.
Overall Study
| Stage | Latent-Control | Latent-VR |
|---|---|---|
| STARTED | 19 | 21 |
| COMPLETED | 19 | 21 |
| NOT COMPLETED | 0 | 0 |
Analysis population for the primary outcome, as defined in the registry: 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
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
Population: Active-Control and Active-VR participants were not recruited
| Characteristic | Unit | Latent-Control | Latent-VR | Total |
|---|---|---|---|---|
| Participants analysed | 19 | 21 | 40 | |
| Age, Continuous | years | 32.47 (27 to 42) | 31.57 (20 to 39) | 32 (20 to 42) |
| Sex: Female, Male: Female | Participants | 19 | 21 | 40 |
| Sex: Female, Male: Male | Participants | 0 | 0 | 0 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 1 | 6 | 7 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 18 | 15 | 33 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 0 | 1 | 1 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 2 | 2 | 4 |
| Race (NIH/OMB): White | Participants | 17 | 14 | 31 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 4 | 4 |
| Gravidity | pregnancies | 1.16 (1 to 3) | 1.29 (1 to 3) | 1.23 (1 to 3) |
| Parity | pregnancies | 0 (0 to 0) | 0 (0 to 0) | 0 (0 to 0) |
| Insurance: HMO / Managed Care | Participants | 0 | 4 | 4 |
| Insurance: Medicaid | Participants | 1 | 2 | 3 |
| Insurance: Private | Participants | 18 | 14 | 32 |
| Insurance: Self-pay / None | Participants | 0 | 1 | 1 |
| BMI | kg/m^2 | 27.29 (22.5 to 38.4) | 30.11 (24.1 to 38.6) | 28.77 (22.5 to 38.6) |
6. Primary Endpoint
The registry lists the primary outcome as Reduction in Pain, measured over 4 hours prior to intervention, immediately pre-intervention, immediately post-intervention, 2, 4, 24 hours post-intervention.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Full Range |
| Unit | score on a scale |
| Endpoint classification | not reduced to a single comparison |
The primary outcome is titled “Reduction in Pain” and is described as a difference in pain scores before and after intervention compared with control. Pain was measured with the Visual Analog Scale for Pain, on a scale from 1 to 10. The record states that the minimum pain is 1, the maximum is 10, and higher values represent more pain. It identifies the outcome parameter as a mean and the reported dispersion as the full range.
The listed measurement times are 4 hours prior to intervention, immediately before intervention, immediately after intervention, and 2, 4, and 24 hours after intervention. Measuring pain at multiple times can describe how scores vary over the period of observation, rather than limiting the question to a single moment. In general, a mean summarizes the central level of scores, while a range describes the span from the smallest to the largest recorded value; neither alone indicates how precisely an arm difference has been estimated.
Pain is a subjective experience, so a patient-reported scale can record participants’ own ratings. The registry record does not report the actual score summaries, an estimated difference between arms, or a confidence interval. It therefore does not show the magnitude or precision of the primary outcome comparison.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record describes a randomized comparison of virtual reality with no intervention among participants in the latent phase of labor. It does not report pain-score estimates, an estimated between-arm contrast, a confidence interval, or a test result. The primary outcome title and measurement schedule describe what the investigators intended to assess, but they do not establish what the results were. No direction or size of a pain-score difference can be determined from the recorded information.
The primary outcome description includes data-availability counts for average pain scores after intervention. At 2 hours after intervention, data were available for 9/19 Latent-Control participants and 14/21 Latent-VR participants. At 4 hours after intervention, data were available for 7/19 Latent-Control participants and 12/21 Latent-VR participants. Those counts describe availability, not the scores themselves. The record does not provide corresponding averages or ranges, nor does it explain why data were unavailable for some participants. Data availability at the other listed measurement times is not reported in the registry record.
The registry lists five outcome measures and four secondary outcomes: need for intravenous pain medication, need for epidural during the intervention, the Childbirth Self-Efficacy Inventory, and need for epidural during labor. It does not report results for these secondary outcomes. The registry records zero analyses. This means no analyses are listed in the record; it should not be read as a result showing no difference between groups or as proof that no analysis was conducted outside the record.
The registry marks the study as terminated, but the reason is not reported in the registry record. Termination alone does not indicate whether the study stopped because of recruitment, operational, safety, or other reasons. The record does not give enough information to attribute the status to any particular cause.
The adverse-event record lists zero serious adverse events among 19 Latent-Control participants and zero among 21 Latent-VR participants. It also records zero deaths in each group. These are safety counts, not evidence about pain-score outcomes. Zero events in the recorded groups do not establish that an event could not occur, and the record does not give the safety observation period or additional detail about event collection.
Overall, the record allows the study question, design, outcome schedule, some follow-up data availability, and recorded safety counts to be described. It does not provide the outcome analysis needed to estimate whether pain ratings differed between the groups, how large any difference might have been, or how precisely it was estimated.
9. Statistical Methods Explained
What does randomization contribute?
In general, randomization assigns participants to study arms by chance. It can help balance both measured and unmeasured participant characteristics across groups, although balance is not guaranteed in any particular trial. That feature supports a comparison of outcomes by assigned group, provided the analysis and follow-up are handled appropriately. The registry record identifies the trial as randomized but does not report the sequence-generation method, allocation concealment, or details of the analysis according to assignment. It is therefore not possible to assess those procedures from the registry record.
The trial is also described as parallel and unmasked. In a parallel design, participants are assigned to one arm rather than crossing between interventions. In general, lack of masking can matter when participants or staff know the assigned intervention, especially for outcomes based on self-report. Pain ratings may be influenced by expectations or by how participants experience the intervention. The record does not explain who knew assignments, whether outcome collection was standardized, or whether the people recording outcomes were masked.
How should the pain measure be understood?
The primary measure is a mean pain score on the Visual Analog Scale for Pain, with values from 1 to 10 and higher values indicating more pain. A mean gives a single summary of the scores in a group at a given assessment. The stated full-range dispersion describes the span of observed values rather than the uncertainty around the mean or the uncertainty around a comparison between groups. In general, a confidence interval describes a range of values compatible with the observed data under a specified statistical procedure. No confidence interval is reported for this outcome.
The planned assessments span the period before intervention and several points afterward. Repeated measurements can help describe whether scores change over time and whether patterns differ between groups. However, scores from the same participant over time are related; they are not independent observations. In general, an analysis of repeated measurements should account for that within-participant relationship. The registry record does not report whether the investigators used a repeated-measures model, separate comparisons at each time, or another approach. It also does not report a model specification, covariate adjustment, or a primary time point selected for a single comparison.
What can the listed data availability tell us?
The registry reports that average pain-score data 2 hours after intervention were available for 9/19 Latent-Control participants and 14/21 Latent-VR participants; at 4 hours after intervention, the corresponding availability counts were 7/19 and 12/21. These counts identify that the reported data do not cover all participants at risk in either group at those times. They do not reveal the missing participants’ pain scores or why those scores were unavailable. In general, missing outcomes can affect an estimate if the likelihood of missingness is related to participants’ outcomes or characteristics. Methods for addressing missing data, if any, are not reported in the registry record.
The record does not identify an analysis population, such as all randomized participants or only participants with available measurements. It does not state how participants who did not receive the assigned intervention, or those with incomplete follow-up, were handled. The data-availability counts should therefore not be treated as a complete description of the analysis set.
What do the analysis and planning details say?
The registry records zero analyses. It does not provide an estimated treatment contrast, a standard error, a confidence interval, a p-value, or a model-based result. Without those results, readers cannot assess statistical evidence for a difference or its precision. In general, a p-value describes how incompatible data are with a specified null model under the assumptions of a test; it does not measure the size or clinical importance of an effect. An estimate and its uncertainty are needed to understand the scale and precision of a comparison.
The registry record describes a planning illustration based on the observed effect, using a two-sided significance level 0.05, equal allocation between two arms, and a normal approximation. It says the effect to detect is a stated fraction of the observed effect. These are planning assumptions, not evidence that the trial was designed with those assumptions or that any particular power was achieved. The record does not report a trial-specific sample-size justification. Sample-size calculations are planning illustrations, not observed power; observed results and their uncertainty are needed to assess what the study found.
In general, over-dispersion means observed variation is greater than a statistical model expects. Accounting for it can affect uncertainty estimates in settings where a model assumes a narrower distribution than the data support. The registry record does not report an over-dispersion assessment or a statistical model for the pain data, so no such adjustment can be attributed to this trial.
How do multiple outcomes and times affect interpretation?
The record lists five outcome measures, including the primary pain outcome and secondary measures related to medication, epidural use, and childbirth self-efficacy. The primary pain outcome itself has several stated assessment times. In general, testing many outcomes or time points can increase the chance of finding an apparently notable result by chance if no adjustment or prespecified hierarchy is used. A multiplicity strategy can control or organize that risk, but it should be specified and interpreted alongside the results. Such a strategy is not reported in the registry record. The record also does not state which outcome or time point, if any, was designated as the sole basis for a confirmatory comparison.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists five outcome measures, including pain as the primary outcome and four secondary outcomes concerning intravenous pain medication, epidural use, and childbirth self-efficacy. The primary pain outcome is described at several assessment times: 4 hours before intervention, immediately before and after intervention, and 2, 4, and 24 hours afterward. Considering several outcomes and times raises a multiplicity question: when many comparisons are examined, the chance of at least one apparently notable result can rise. In general, prespecified priorities or statistical adjustment can help clarify how multiple results should be interpreted. A multiplicity plan is not reported in the registry record.
Missing outcome data are evident in the recorded availability counts for pain scores 2 and 4 hours after intervention. The record does not give a reason for unavailable measurements, results for other time points, or a method for handling missing observations. It does not report whether analyses used all randomized participants, only those with observed outcomes, or another analysis population. The distinction matters because an analysis limited to available observations can represent a different group from the full randomized population.
The registry records zero analyses and does not report an intention-to-treat analysis, a per-protocol analysis, or any other population definition. It also does not report whether the analysis plan was prespecified, how protocol deviations were handled, or whether missing-data sensitivity analyses were performed. These details are not reported in the registry record, so the listed data availability cannot be used to reconstruct the analysis population or the assumptions behind any result.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Latent-Control | 0 | 19 | 0.0% |
| Latent-VR | 0 | 21 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Latent-Control | 0 of 19 |
| Latent-VR | 0 of 21 |
| Active-Control | 0 of 0 |
| Active-VR | 0 of 0 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Latent-Control | 0 of 19 |
| Latent-VR | 0 of 21 |
| Active-Control | 0 of 0 |
| Active-VR | 0 of 0 |
The adverse-event record lists zero serious adverse events among 19 participants in Latent-Control and zero among 21 participants in Latent-VR. It also records zero other adverse events and zero deaths in each of those groups. The record lists no serious adverse-event terms. These are counts recorded for the two populated arms.
Active-Control and Active-VR are also listed, but each has zero participants at risk. Those entries do not provide safety information for a group with participants; they should not be interpreted as evidence that the intervention caused no adverse events in such a group.
In general, an observed count of zero means no events were recorded in the stated group during the period captured by the record. It does not demonstrate that the underlying event risk is zero. The safety observation period, event-collection procedures, and the extent of follow-up for safety are not reported in the registry record. The counts also do not answer the primary pain question or establish a comparative safety effect.
12. What the Result Does, and Does Not, Mean
The registry record identifies a randomized comparison of a virtual reality device with no intervention for participants in the latent phase of labor. It specifies pain scores as the primary outcome and lists multiple assessment times. It also records data availability for average pain scores at 2 and 4 hours after intervention, and adverse-event counts for the two populated arms. These details describe the question and some aspects of the recorded study, but they do not constitute an estimate of the intervention’s effect.
No arm-level pain averages, ranges, between-arm differences, confidence intervals, or p-values are reported. Consequently, the size, direction, and precision of a pain-score comparison cannot be established from the registry record. The absence of reported analyses is not a finding of no effect, and it is not evidence that the groups had identical outcomes. It means that the registry record does not supply the results required to assess that comparison.
The recorded availability counts show that pain-score data were available for only some participants at the stated post-intervention times. Without explanations for missing data or methods for analyzing them, readers cannot determine whether the reported availability patterns could have affected an estimate. The record also does not report results for the listed secondary outcomes or explain how multiple outcomes and assessment times were handled.
The safety counts show no recorded serious adverse events or deaths in the two populated groups. Such counts are limited to what the registry reports and do not establish that adverse events are impossible or characterize risk beyond the recorded follow-up. The trial’s terminated status is recorded, but the reason is not reported in the registry record.
In general, trial interpretation depends on estimates, uncertainty, outcome completeness, and the analysis approach, as well as the design. Here, the registry record supports a description of the trial’s structure and selected reporting details, but not a conclusion about whether pain scores differed between arms or how meaningful any difference might have been.
13. Why This Trial Matters Statistically
This trial raises a useful statistical question because pain is measured repeatedly, before and after an intervention, and the primary description frames the outcome as a difference in pain scores compared with a control group. A treatment comparison based on change over time depends not only on the scores at each assessment but also on how those repeated observations are analyzed. In general, measurements from the same participant are related, so a method that accounts for this relationship can matter when estimating uncertainty.
The registry record also illustrates why outcome availability belongs alongside outcome results in interpretation. At the stated post-intervention times, data are reported for subsets of the participants at risk. Those counts do not reveal the missing values or the reasons they are missing, but they identify a question that an analysis should address. Without the analysis method and missing-data handling, the reader cannot know how the recorded data were used to reach a result.
Multiple outcome measures and multiple assessment times create another statistical consideration. In general, looking across many comparisons can complicate interpretation unless priorities and multiplicity handling are clear. The registry does not report such a plan or list analyses, so the record cannot show how the investigators intended to distinguish a primary comparison from exploratory ones.
Finally, the trial is listed as terminated, yet the termination reason is not reported in the registry record, and no outcome estimates are listed. That combination makes it especially important to separate what the design intended to study from what the available record can support. The record documents the research question and selected operational details, but the statistical evidence needed to assess the primary comparison is not reported.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
Several trial-specific limitations of interpretation follow from the registry record. First, the primary outcome description does not include pain-score summaries or a comparison between arms. The record lists zero analyses, so there is no reported estimate or measure of uncertainty on which to base an assessment of the primary question. The reason for the study’s terminated status is not reported in the registry record.
Second, outcome availability is incomplete at the post-intervention times for which counts are given. The registry records data for 9/19 Latent-Control participants and 14/21 Latent-VR participants at 2 hours, and for 7/19 and 12/21, respectively, at 4 hours. It does not report why the other measurements were unavailable, or how missing data were addressed. Availability at the other stated measurement times is not reported in the registry record.
Third, important analytic details are not reported: the analysis population, the statistical model, handling of repeated measurements, adjustments for baseline values or other covariates, and a plan for multiple outcomes or times. The randomization procedure and allocation concealment details are also not reported. Without these details, the registry record does not allow readers to evaluate how the comparison was estimated or how sensitive it might be to analytic choices.
Finally, the record gives limited detail about the device, intervention delivery, eligibility criteria, masking procedures, follow-up, and safety-event collection. It lists four secondary outcomes but does not report their results. These gaps limit interpretation of both the primary question and the broader clinical context; they should not be filled by assumptions about the study protocol.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Virtual Reality in Labor and Delivery for Reduction in Pain — NCT03437031.
- Registry record last updated 2021-11-26; status last verified 2021-10.
- Results first posted 2021-11-26.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
NCT03437031 is a randomized, parallel-group, unmasked study sponsored by Cedars-Sinai Medical Center. It evaluates a virtual reality device for participants in the latent phase of labor, compared with no intervention. Enrollment is recorded as 40, and the status is TERMINATED. The start date is 2018-03-01; the primary completion date is 2019-02-19.
The primary outcome is pain measured on the Visual Analog Scale for Pain, from 1 to 10, with higher values indicating more pain. Measurements were planned from before intervention through 24 hours afterward. The registry reports partial data availability counts at 2 and 4 hours after intervention but no pain-score estimates or analyses. Four secondary outcomes are listed, with no results reported. No multiplicity plan, missing-data method, analysis population, or reason for termination is reported in the registry record. The adverse-event record lists zero serious events and zero deaths in each of the two populated arms.