This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record.
1. Trial at a Glance
| Feature | REALITY Plus |
|---|---|
| Title | Traditional Versus Virtual Reality for Surgical Skills for ObGyn Residents |
| Sponsor | Hospital de Clinicas de Porto Alegre |
| Phase | NA |
| Allocation | Randomized |
| Masking | None |
| Primary purpose | Other |
2. Clinical Question
Population
ObGyn residents undergoing surgical skills training.
Intervention
Virtual Reality plus conventional training.
Comparator
Conventional training.
Primary question
Does adding virtual reality training affect technical skills efficiency?
3. Trial Design
The registry describes a randomized, parallel-group trial with two intervention groups and no masking.
Arm 1
Conventional training (behavioral).
Arm 2
Virtual Reality + conventional training (behavioral).
4. Endpoints
| Endpoint | Time frame | Description |
|---|---|---|
| Efficiency of technical skills (%) | 12 weeks | Software analysis of surgical performance measures including needle-holder positioning, tissue handling, needle loading, knot formation, suturing measures, and salpingectomy-related efficiency measures. |
5. Statistical Methodology
The registry identifies a randomized comparison with a continuous percentage-based technical skills endpoint. A typical analysis for this endpoint would compare the efficiency measure between randomized groups using an appropriate two-group statistical method, with the exact model depending on the distribution of the outcome and prespecified analysis plan.
The registry reports measurement of efficiency of technical skills at 12 weeks. Results have not been posted on ClinicalTrials.gov.
6. Statistical Methods Explained
Why does randomization matter?
Randomization creates the intended basis for comparing training strategies because assignment is determined by the study design rather than participant characteristics.
What does a technical skills percentage measure represent?
A percentage-based efficiency endpoint summarizes performance using defined components of the surgical task. The interpretation depends on how the score is constructed and validated.
Why might continuous outcomes be useful in training studies?
Continuous measures can capture differences in degree of performance rather than only whether a participant reaches a predefined success threshold.
Why is the analysis method important?
The statistical method must match the structure of the outcome, sample size, and assumptions about measurement variability.
7. Limitations
- The registry status is listed as UNKNOWN.
- The total enrollment was 24 participants, which limits precision of estimated differences between groups.
- The trial was unmasked, so awareness of training assignment may influence performance measurement.
- ClinicalTrials.gov does not report posted statistical analyses, effect estimates, confidence intervals, or p-values for the primary endpoint.
8. Why This Trial Matters Statistically
| Concept | Application |
|---|---|
| Randomized design | Comparison of two training approaches through assigned groups. |
| Parallel groups | Each participant receives one assigned training strategy. |
| Continuous endpoint | Technical skills efficiency measured as a percentage. |
| Measurement methodology | Software-derived performance metrics provide structured assessment. |
| Sample size considerations | Small randomized studies require careful interpretation of uncertainty. |