Augmented Reality Distraction for Reducing Pain in Pediatric Dental Procedures: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Augmented Reality Distraction for Reducing Pain in Pediatric Dental Procedures (NCT06954883), a randomized na study. The primary outcome is Pain Score Using Wong-Baker FACES Scale.

2. Clinical Question

The clinical question concerns a short-term, patient-reported pain score during a specific pediatric dental procedure. It is not a comparison of different dental treatments: both groups underwent extraction, while the distraction or behavior-guidance approach differed. The registry describes a randomized, double-blind, parallel-group trial. The posted arm summaries include the primary pain outcome and two secondary measures: the Children's Fear Survey Schedule-Dental Subscale and heart rate as a physiological indicator of anxiety.

The central statistical comparison is between the mean score in the AR-based distraction group and the mean score in the tell-show-do group. The estimate is expressed as the AR group mean minus the standard-care group mean, so a negative value corresponds to a lower posted mean in the AR group. That direction describes the observed scores; it does not by itself establish how meaningful the difference is to children or families. The registry record does not report a threshold for a clinically important difference.

3. Trial Design

The registry describes a randomized, double-blind, parallel-group controlled trial sponsored by Assiut University. The trial is marked completed, with enrollment of 60. The recorded start date is 2025-05-15, and the primary completion date is 2025-07-30. The posted outcome summaries contain 30 participants in each group. The arms are AR-based distraction and standard care using the tell-show-do technique.

In the AR arm, participants wore AR/VR goggles displaying an interactive cartoon during local anesthesia injection and extraction. The comparator group received standard tell-show-do behavior guidance during treatment. The study population is described as children aged 6-10 undergoing primary tooth extraction. The registry lists dental anxiety as a condition and identifies no applicable phase.

Random allocation and double masking are recorded, but the method used to generate the random sequence, the allocation-concealment procedure, and the people who were masked are not reported in the registry record. The feasibility of masking participants to the behavior-management approach is also not explained. The planned sample-size rationale and the trial's original design assumptions are not reported in the registry record. No interim analyses or changes to the planned design are reported in the registry record.

The primary endpoint is a mean pain score on the Wong-Baker FACES scale, reported with a standard deviation. The registry also posts two secondary measures: fear on the Children's Fear Survey Schedule-Dental Subscale and post-procedure heart rate. Each posted outcome summary has 30 participants per arm. The record does not provide a participant-flow account, explain whether all randomized participants contributed to every outcome, or identify an analysis population such as intention-to-treat. These omissions limit assessment of how the analyzed groups relate to the randomized groups.

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: Number of Participants Screened: 60 eligible participants were enrolled after screening Reasons for Exclusions: * previous anesthesia experience, special needs, anxiety disorder diagnosis, recent root planing) * Declined to participate Number Assigned to Arms: * AR Group: 30 participants * Control Group: 30 participants

Overall Study

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: All randomized participants (N=60; AR group n=30, Control group n=30) were included in baseline analyses. No participants were excluded after randomization, and baseline data were complete for all individuals.

6. Primary Endpoint

The registry lists the primary outcome as Pain Score Using Wong-Baker FACES Scale, measured over Immediately after the dental extraction procedure..

The primary endpoint is the Wong-Baker FACES pain score, recorded as a numeric score after the dental procedure. The scale is described as containing six facial expressions spanning 0, labeled No pain, to 10, labeled Worst pain. A child selects the face that best represents the pain experience, and the selected face is converted into a score. The registry reports the outcome as a mean and standard deviation for each group.

A child-focused self-report measure is relevant because pain is a subjective experience and the child is the person experiencing it. The faces provide a visual way to express pain and translate a selection into a numeric value that can be summarized and compared between groups. As a continuous outcome, the analysis can describe the average score and the spread of scores within each group. The mean gives a group-level summary; the standard deviation describes how much individual scores vary around that mean.

The recorded timeframe is immediately after the dental extraction procedure. However, the endpoint description also says that pain was assessed immediately after local anesthesia injection. Those are not necessarily the same moment in treatment. The registry record does not resolve this timing difference, so interpretation should preserve that uncertainty rather than assume a single assessment point. The record does not report a threshold for a clinically important change on this scale or explain how children who could not select a face would be handled.

7. Results Posted in the Registry

• AR-based Distraction: mean 2.30 versus 4.50 on control; difference -2.20 (95% CI -2.83 to -1.57), standardized effect d = -1.76; z-test p = <0.001.

8. Secondary Efficacy Endpoints

The registry also posts results for secondary outcomes. For each outcome below, the endpoint type, the test applied to the posted summary statistics, the result and its interpretation are given in turn. Secondary endpoints are usually not adjusted for multiple testing, so they support rather than confirm the primary finding.

1. Children's Fear Survey Schedule-Dental Subscale

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • AR-based Distraction: mean 17.60 versus 26.80 on control; difference -9.20 (95% CI -11.33 to -7.07), standardized effect d = -2.18; z-test p = <0.001.
• Interpretation:
  • The 95% confidence interval excludes no difference, so the mean is statistically lower for AR-based Distraction than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.

Heart Rate as Physiological Indicator of Anxiety

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • AR-based Distraction: mean 80.00 versus 89.00 on control; difference -9.00 (95% CI -13.58 to -4.42), standardized effect d = -0.99; z-test p = <0.001.
• Interpretation:
  • The 95% confidence interval excludes no difference, so the mean is statistically lower for AR-based Distraction than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.

The secondary outcomes show a pattern in the same direction as the primary endpoint: the posted means for fear and post-procedure heart rate are lower in the AR-based distraction group than in the tell-show-do group. The unadjusted recalculated comparisons for both outcomes have p-values <0.001, and their reported confidence intervals lie below zero. This directional consistency can be viewed as descriptive coherence across different measures related to the procedure and anxiety.

The secondary endpoints do not measure the same construct as the primary pain score. A fear questionnaire captures reported dental fear, while heart rate is a physiological measure that can reflect many influences. Agreement in direction does not show that the measures are interchangeable or that one explains another. The registry does not report an analysis linking changes in pain, fear, and heart rate, or a formal mediation analysis.

These secondary results carry less weight as confirmatory evidence because the registry does not report a multiplicity plan, a hierarchy of outcomes, or formal sponsor analyses. When several outcomes are examined, unadjusted p-values do not account for the fact that multiple comparisons were made. This can make apparently strong findings less conclusive as a family of tests, especially when the analysis plan and outcome-selection process are unclear.

The registry lists the fear score and heart rate as secondary outcomes, and the posted results contain group summaries and recalculated comparisons for both. The registry record does not report whether these outcomes were prespecified in a detailed analysis plan, how missing measurements were handled, or whether any other secondary outcomes were measured but not posted. The observed pattern is therefore useful context for the primary result, but should not be treated as independent replication or as proof of a common underlying mechanism.

Secondary outcomes registered for this trial, for reference (only those above were recalculated):

• 1. Children's Fear Survey Schedule-Dental Subscale
• Heart Rate as Physiological Indicator of Anxiety

9. Statistical Interpretation

10. Statistical Methods Explained

The posted outcomes are continuous measures summarized by group means and standard deviations. A mean is the arithmetic average of the recorded scores, while a standard deviation describes how dispersed the individual observations are around that average. These summaries make the central tendency and within-group variability visible, but they do not show every individual score or reveal whether distributions have unusual shapes. The registry does not provide plots of individual observations or distributional diagnostics in its reported analysis results.

What does a mean difference express?

The primary comparison is a mean difference with the AR group first and tell-show-do care second. In that ordering, a negative estimate means the AR group's posted mean is lower. The reported estimate is -2.2. This is a difference on the score scale, not a percentage change or a ratio. A mean difference is interpretable in the original units of the outcome, but its practical importance depends on the scale's meaning and on a clinically important threshold. No such threshold is reported in the registry record.

For the primary outcome, the 95% confidence interval is -2.833 to -1.567. A confidence interval is a range of estimates compatible with the data and the assumptions of the calculation; it conveys uncertainty about the estimated group difference. It does not mean that a stated proportion of individual children had scores inside that range, nor does it measure the spread of scores within either arm. The standard deviations describe within-arm spread; the interval describes uncertainty around the between-arm estimate.

How should the p-value be read?

The unadjusted p-value for the recalculated primary comparison is <0.001. In general, a p-value quantifies how unusual data at least as inconsistent with a specified null model would be if that model and the test assumptions held. It is not the probability that the null hypothesis is true, and it does not measure the size or importance of an observed difference. The registry labels the displayed comparison unadjusted. The statistical test and its assumptions are not reported in the registry record, so the p-value should be understood as part of the recalculated comparison rather than as a fully documented sponsor analysis.

Randomization is intended to make the groups comparable on average at baseline, including on factors that were not measured. It does not guarantee exact balance in a particular trial, and the registry record does not post baseline characteristics that would permit a check of group balance. Masking can reduce some forms of expectation or assessment bias when applied successfully, but the record does not specify who was masked or how masking was maintained. The presence of the design labels alone cannot answer those operational questions.

Why does the choice of analysis matter?

An analysis plan specifies how outcomes, participants, and statistical comparisons will be handled. For example, a plan can state which participants are included, how missing observations are treated, and whether comparisons are adjusted for other variables. Such choices can affect estimates and their uncertainty. The registry lists no reported analyses, and the original statistical analysis plan is not reported in the registry record. It is therefore not possible to determine whether the recalculated unadjusted comparisons match the planned primary analysis.

The registry lists three outcome measures in total: the primary pain score and two secondary endpoints. When several outcomes are examined, the chance of at least one apparently strong result can increase if no multiplicity strategy is used. A prespecified hierarchy, adjustment, or distinction between confirmatory and exploratory analyses can help clarify how evidence across outcomes should be interpreted. Such a strategy is not reported in the registry record. The p-values for the secondary comparisons are unadjusted, so they should not be read as if multiplicity had been addressed.

What can the sample-size illustrations tell readers?

The planning illustrations use the observed effect as their reference and show participant counts per arm under stated assumptions. They are not a record of the trial's original design calculation. An illustration based on the effect observed in a small trial can be optimistic because that estimate is uncertain and may be larger or smaller than the effect in future studies. The original sample-size justification is not reported in the registry record. These figures help explain how target effect size and desired power influence planning; they do not establish the probability that this completed trial detected an effect.

Over-dispersion is a general concern when the variability in the data is greater than a model assumes. Greater variability can make an estimated difference less precise and can require more participants to detect a given effect under a specified design. The primary endpoint is summarized with a standard deviation, but the registry does not report model diagnostics or an analysis that evaluates distributional assumptions. With a bounded score and a modest group size, checking the distribution and robustness of the chosen method can be informative; the record does not indicate whether those checks were performed.

The reported mean differences and intervals are unadjusted recalculations from posted summary statistics. They are straightforward descriptions of the arm summaries, but do not account for covariates or undocumented analytic decisions. General statistical explanations do not substitute for information about the actual analysis. The specific test, missing-data procedure, analysis population, and handling of protocol deviations are not reported in the registry record.

11. Confidence Intervals and Precision

For the primary pain outcome, the recalculated mean difference is -2.2 points, with a 95% confidence interval from -2.833 to -1.567. The interval gives a range of plausible values for the average difference under the calculation's assumptions. Since its reported limits are both below zero, the interval is consistent with a lower average posted pain score in the AR group. It does not determine whether the difference is important to children, because a clinically important threshold is not reported in the registry record.

Precision and statistical significance are related but not interchangeable. A p-value of <0.001 accompanies the recalculated comparison, while the confidence interval makes the range of estimated differences more concrete. Neither provides a direct measure of how much individual children's scores varied; the group standard deviations are 1.2 and 1.3. Nor does the interval address potential bias from missing data, unclear assessment timing, or choices in the analysis plan.

The two secondary comparisons also have reported intervals. For the Children's Fear Survey Schedule-Dental Subscale, the recalculated mean difference is -9.2, with a 95% confidence interval from -11.33 to -7.069. For heart rate, the mean difference is -9.0 beats per minute, with a 95% confidence interval from -13.58 to -4.417. These ranges quantify uncertainty in their respective unadjusted comparisons, but they do not resolve multiplicity or establish the importance of the differences.

All three comparisons are based on posted summaries with 30 participants per arm. Confidence intervals can be sensitive to the method used and to the assumptions behind that method. The registry does not report the sponsor's interval-estimation procedure or a formal analysis output. The recalculated intervals should therefore be read as summary-statistic-based estimates, not as a complete account of all uncertainty in the trial.

12. Planning a Similar Trial: Sample Size

This is a planning illustration, not a re-evaluation of the original trial. It asks: if a new study wanted to detect a difference like the one observed, or a smaller one, how large would it need to be? It is deliberately not “observed power” of the finished trial, which is not a meaningful quantity.

The sample-size illustrations give participants per arm, not a combined total and not event counts. They use a two-sided significance level 0.05, equal allocation between the two arms, and a normal approximation. The effect to detect is set to the stated fraction of the observed effect. These are planning assumptions for an illustration; the trial's original design assumptions and sample-size justification are not reported in the registry record.

For the primary pain comparison, planning for 100% of the observed effect gives 6 participants per arm for 80% power and 7 participants per arm for 90% power. Planning for 75% of the observed effect gives 10 participants per arm for 80% power and 13 participants per arm for 90% power. Planning for 50% of the observed effect gives 21 participants per arm for 80% power and 28 participants per arm for 90% power.

In plain language, power is the chance, under a specified set of assumptions and a particular true effect, that a planned study will produce a result meeting its chosen statistical criterion. The 80% column describes a design targeting 80% power under the stated assumptions; the 90% column describes a design targeting 90% power. A higher target power generally requires more participants when other assumptions are held fixed. The illustrations also show that smaller effects need more participants to detect than larger effects under the same planning framework.

The calculations use the observed effect as a reference, which is uncertain. They are not observed power: they do not tell whether the completed trial had a particular probability of detecting an effect after its results were known. They also do not recover the original planning process, which is not reported in the registry record.

13. How the Sample Size Is Derived

Power is the probability that a study of a given size rejects the null hypothesis when a specific true effect exists. It depends on four things: the effect to detect, the variability of the outcome, the significance level (here a two-sided α of 0.05, so z_1−α/2 = 1.960) and the desired power (z_1−β = 0.842 for 80% and 1.282 for 90%).

Formula

n is the number of participants in each arm, Δ is the difference in means to detect and σ is the common standard deviation.

Worked calculation for this trial

1. Observed difference Δ = -2.200; pooled standard deviation σ = 1.251.
2. n = 2 × (1.96 + 0.842)² × 1.251² / -2.200² = 5.1, rounded up to 6 participants per arm for 80% power.

The smaller-effect rows in the table above repeat the same calculation with the effect multiplied by 0.75 and 0.5 (for ratios, applied to the logarithm of the ratio).

R code

alpha <- 0.05
z_a   <- qnorm(1 - alpha / 2)          # two-sided
delta <- -2.2                      # observed difference in means
sigma <- 1.25099960031968                     # pooled standard deviation
n_per_arm <- function(power, frac = 1) {
  ceiling(round(2 * (z_a + qnorm(power))^2 * sigma^2 / (delta * frac)^2, 6))
}
for (f in c(1, 0.75, 0.5))
  cat(sprintf("%3.0f%% of observed effect: n per arm = %s (80%% power), %s (90%% power)\n", 100 * f,
              format(n_per_arm(0.80, f), big.mark = ","), format(n_per_arm(0.90, f), big.mark = ",")))

# Check against R's built-in function (t-based, so very slightly larger)
cat("power.t.test:", round(power.t.test(delta = delta, sd = sigma, power = 0.80)$n, 1), "\n")

# Simulation: exact two-sample t-test using simulated means and variances
set.seed(6954883)
n    <- n_per_arm(0.80)
reps <- 20000
m_diff <- rnorm(reps, delta, sigma * sqrt(2 / n))             # difference in sample means
s2     <- sigma^2 * rchisq(reps, 2 * (n - 1)) / (2 * (n - 1))   # pooled sample variance
tstat  <- m_diff / sqrt(s2 * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(tstat) > qt(0.975, 2 * (n - 1))), reps))

Output from running the code

100% of observed effect: n per arm = 6 (80% power), 7 (90% power)
 75% of observed effect: n per arm = 10 (80% power), 13 (90% power)
 50% of observed effect: n per arm = 21 (80% power), 28 (90% power)
power.t.test: 6.2 
Simulated power at n = 6 per arm: 0.784 (20000 replicates)

The simulation draws many sets of group means and variances at the planned sample size and counts how often the two-sample t-test rejects the null. It should land close to the target power; at very small required sample sizes it can fall below it, because the normal approximation is rough there.

14. Multiplicity, Missing Data and Analysis Populations

The registry lists one primary outcome and two secondary outcomes. It does not report a plan for handling multiplicity, such as an adjustment across outcomes, a hierarchy for testing, or a distinction between confirmatory and exploratory comparisons. Without that information, the unadjusted p-values for the secondary outcomes should be interpreted cautiously. Even for the primary outcome, the record does not describe whether any other analyses or comparisons were prespecified.

The registry reports no analyses in its analysis listings, and no formal analyses are reported for the secondary outcomes. The mean differences, confidence intervals, and p-values discussed for the posted group summaries are recalculated unadjusted comparisons. The statistical test used by the trial investigators, any covariate adjustment, and the original analysis plan are not reported in the registry record. The discrepancy flag is false, so there is no stated discrepancy between the posted summaries and a sponsor analysis that would require the sponsor's own analysis to take precedence.

Missing-data handling is not reported in the registry record. The outcome summaries list 30 participants in each group, but the record does not give a participant-flow account or explain whether these are all randomized participants, whether every participant contributed to every outcome, or whether observations were excluded. Reasons for missingness, if any, are not reported. This prevents assessment of whether the analyzed observations could differ systematically from those without reported outcomes.

The analysis population is also not reported. The record does not say whether analyses followed initial randomized assignment, included only participants who completed treatment, or used another population definition. Protocol deviations and their handling are not reported. These details matter because excluding participants or analyzing them according to treatment received can affect the balance created by randomization.

The registry record does not report interim analyses, stopping rules, or a data-monitoring process. Their absence from the record should not be taken as evidence that a particular procedure was or was not used. Overall, the registry contains enough arm-level information for simple comparisons, but not enough analysis-plan detail to assess prespecification, missingness, or the full set of statistical decisions.

15. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

The posted serious adverse event figures show 0 affected participants among 30 at risk in the AR Distraction group and 0 among 30 at risk in the Tell-Show-Do group. The recorded deaths are 0 in both groups. The figures for other adverse events also show 0 affected participants among 30 at risk in each group.

These entries mean that the registry reports no participants with serious or other adverse events in either arm for the categories displayed. They do not establish that no symptoms or unwanted experiences occurred outside the registry's definitions or reporting period. The registry record does not report the adverse-event observation window, event-collection procedures, severity grading details, or how events were attributed to an intervention. No serious adverse event terms are listed.

Zero reported events in groups of this size provide limited information about uncommon harms. They should be read as the recorded counts, not as proof that a risk is absent. The safety figures are also distinct from the efficacy comparisons: they do not change what the pain-score summaries show, and they do not resolve limitations in outcome timing, missing-data reporting, or analysis methods.

16. What the Result Does, and Does Not, Mean

The posted results describe lower average pain scores in the AR-based distraction group than in the tell-show-do group, with an unadjusted recalculated mean difference of -2.2 points and a 95% confidence interval from -2.833 to -1.567. The secondary summaries point in the same direction for fear scores and heart rate. Those observations are specific to the participants, outcomes, and procedure described in the registry record.

The results do not establish that every child experienced less pain or anxiety, because group means do not describe every individual response. They do not establish how many children experienced a meaningful difference, since individual-level outcomes and a clinically important threshold are not reported. A statistically strong comparison is not, by itself, evidence that a difference is important in practice.

The results also do not establish that augmented reality caused the observed differences without qualification. Randomization supports causal comparison when implemented and analyzed appropriately, but the registry does not detail sequence generation, allocation concealment, masking procedures, analysis populations, or handling of missing data. The endpoint timing description is inconsistent about whether the pain score was recorded immediately after extraction or immediately after local anesthesia injection. These reporting gaps limit confidence in exactly what the primary score represents and how the comparison was conducted.

The findings do not show that the same pattern would occur for other ages, dental procedures, settings, or forms of distraction. The registry describes children aged 6-10 undergoing primary tooth extraction and reports a total enrollment of 60. It does not provide evidence about longer-term outcomes or outcomes beyond those posted. Nor do the results identify a mechanism linking the intervention to the scores.

The most defensible reading is that the posted group summaries show lower average values in the AR-based group on the recorded outcomes, with unadjusted comparisons that favor that group's lower scores. The degree of clinical importance, generalizability, and robustness to alternative analytic choices remain uncertain from the registry record.

17. Why This Trial Matters Statistically

This trial raises several useful statistical questions in a focused clinical setting. The primary outcome is a child-reported pain score, while the secondary outcomes include a fear questionnaire and a physiological measure. Comparing different types of outcomes can show whether the observed pattern is limited to a single measure or appears across related dimensions, while also requiring care not to treat distinct constructs as interchangeable.

The record illustrates why estimates and uncertainty are more informative than a p-value alone. The primary mean difference is presented on the outcome's own scale, and its confidence interval gives a range of values consistent with the recalculation. At the same time, no clinically important threshold is reported, so statistical evidence cannot settle whether the magnitude matters to children or families.

It also illustrates the value of transparent analysis reporting. Randomization and masking are recorded, but important operational details, missing-data handling, analysis populations, and multiplicity procedures are not reported. Those details determine how readers can evaluate whether the posted comparison follows the intended design and how much confidence to place in secondary findings.

Finally, the planning illustrations make clear that sample-size decisions depend on the effect a study aims to detect. A smaller target effect requires more participants under otherwise comparable assumptions. Using an observed effect for planning can be informative as an illustration, but it cannot replace the original design rationale or guarantee that a future study will see the same magnitude. The record offers a compact example of how outcome definition, precision, multiplicity, and planning assumptions all shape interpretation.

18. 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 limitations are specific to the information available for this trial. First, the primary endpoint timing is not described consistently: the timeframe says immediately after the dental extraction procedure, while the endpoint description says immediately after local anesthesia injection. Those moments may capture different parts of the treatment experience, and the registry record does not clarify which measurement time was used for the posted values.

Second, the registry does not describe how randomization was generated or concealed, or identify who was masked. Although the trial is labeled double-blind, the procedures supporting that label are not reported. This matters for an intervention involving visible AR/VR goggles and a behavioral comparison, where the masking arrangements would help readers assess potential expectation and assessment effects.

Third, the record does not report baseline characteristics, participant flow, missing outcomes, or an analysis population. The posted summaries list 30 participants per arm, but do not explain whether all randomized participants contributed to each measure or whether any data were excluded. The methods used for the comparisons and confidence intervals are also not reported as sponsor analyses; the posted comparisons are simple unadjusted recalculations.

Fourth, the registry does not report a sample-size justification, a multiplicity strategy, a clinically important difference for the pain scale, or detailed procedures for adverse-event collection. The absence of these details limits assessment of the design rationale, the confirmatory status of the secondary outcomes, practical importance, and safety surveillance. The record also does not provide longer-term outcomes, so interpretation is confined to the immediate measures that were posted.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: Augmented Reality Distraction for Reducing Pain in Pediatric Dental Procedures — NCT06954883.
• Registry record last updated 2026-01-06; status last verified 2025-12.
• Results first posted 2026-01-06.
• 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.

22. Record Summary

NCT06954883 is a completed randomized, double-blind, parallel-group trial sponsored by Assiut University. It enrolled 60 children aged 6-10 undergoing primary tooth extraction and compared AR-based distraction using AR/VR goggles with standard tell-show-do behavior guidance. The recorded start date is 2025-05-15, and the primary completion date is 2025-07-30.

The primary outcome is a Wong-Baker FACES pain score, with posted means of 2.3 in the AR group and 4.5 in standard care, based on 30 participants per arm. The recalculated unadjusted mean difference is -2.2, with a 95% confidence interval from -2.833 to -1.567 and p <0.001. Two secondary outcomes, fear score and post-procedure heart rate, have lower posted means in the AR group as well.

The registry does not report formal analyses, multiplicity handling, missing-data procedures, analysis populations, or a sample-size justification. The primary endpoint description also leaves uncertainty about the exact assessment time. These reporting gaps should accompany interpretation of the observed group differences.