Musically-Guided Paced Breathing Improves Mental Health in War-Affected Adolescents: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Musically-Guided Paced Breathing Improves Mental Health in War-Affected Adolescents (NCT06988800), a randomized na study. The primary outcome is Revised Children's Manifest Anxiety Scale (RCMAS).

2. Clinical Question

3. Trial Design

The registry record describes a randomized, double-masked, parallel-group trial with an enrollment of 213. Its status is completed. The recorded start date is 2024-01-21, and the primary completion date is 2024-05-09. The phase is listed as not applicable. Muvik Labs is identified as the sponsor.

The posted outcome data include three arms: Guided Paced Breathing Audiovisual Intervention, Guided Mindfulness Audiovisual Intervention, and Control. The posted group sizes for the primary outcome are 64, 77, and 72, respectively. The record describes the control activity as typical after-school activities, but the control description ends mid-sentence. More detail about what participants did, how the interventions were delivered, and what masking meant in practice is not reported in the registry record.

The brief summary refers to mindfulness, paced breathing, paced breathing with a take-home application, and a matched control. However, the reported arm descriptions and primary-outcome results show the paced-breathing arm, mindfulness arm, and control arm; a separate take-home arm is not included in those posted results. The registry record does not explain this difference in descriptions.

The primary outcome is the RCMAS, recorded as a mean and standard deviation, with measurement from enrollment to the end of treatment at 12 weeks. Three outcome measures and three analyses are listed, but no secondary outcomes are posted in the record. The original design assumptions, detailed randomization procedures, allocation concealment, masking procedures, and any protocol deviations are not reported in the registry record. Random allocation and masking are features of the recorded design, but the record does not supply enough detail to evaluate how they were implemented.

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.

Intervention Period 1 - 5 Weeks

Intervention Period 2 - 2 Weeks

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.

6. Primary Endpoint

The registry lists the primary outcome as Revised Children's Manifest Anxiety Scale (RCMAS), measured over From enrollment to the end of treatment at 12 weeks.

The primary endpoint is the Revised Children's Manifest Anxiety Scale (RCMAS), a self-report questionnaire about feelings or actions. Its 37 items ask respondents to answer yes or no according to whether each item is typical of their own feelings or actions. The scale produces a total anxiety score as well as subscales for physiological anxiety, worry/oversensitivity, and social concerns/concentration. The registry record describes an Arabic version as having acceptable reliability and validity in youth.

The total score ranges from 0-37, with higher scores indicating greater anxiety. The endpoint is recorded as a mean with a standard deviation, so the posted results describe the average score and variation in each group rather than the number crossing a threshold. The record identifies the measurement timeframe as enrollment to the end of treatment at 12 weeks.

General: A continuous score can retain information across its scale and can be summarized by a group mean. Its interpretation depends on knowing the direction of the scale, the population measured, and the time point. Here, the direction is stated: higher RCMAS scores represent greater anxiety. The registry record does not report a threshold for clinically important change or a minimal important difference. Therefore, the numerical difference in group means should not be treated as an established measure of clinical importance.

7. Results Posted in the Registry

• Guided Paced Breathing Audiovisual Intervention: mean 24.88 versus 17.91 on control; difference 6.97 (95% CI 4.46 to 9.48), standardized effect d = 0.92; z-test p = <0.001.
• Guided Mindfulness Audiovisual Intervention: mean 26.20 versus 17.91 on control; difference 8.29 (95% CI 5.98 to 10.60), standardized effect d = 1.17; z-test p = <0.001.

8. Statistical Interpretation

9. Statistical Methods Explained

General: The posted primary outcome is continuous, and its arm-level summaries are means and standard deviations. A mean describes the arithmetic center of scores in a group; a standard deviation describes their spread around that center. Neither summary shows the full distribution of individual scores. Group-level means also do not indicate whether each participant's score changed in the same direction.

What does an unadjusted mean difference represent?

The recalculated mean difference compares each intervention group's posted endpoint mean with the control group's posted endpoint mean. The direction used is intervention minus control. A positive estimate therefore indicates a higher average RCMAS score in the intervention arm, and higher scores indicate greater anxiety. The paced-breathing comparison is 6.97, while the mindfulness comparison is 8.29. These estimates are simple unadjusted re-calculations from the posted summary statistics. They are not adjusted for baseline scores or other factors.

General: An unadjusted comparison treats the group summaries as the basis for estimating the difference, without incorporating covariates. An adjusted analysis can account for specified covariates, but its meaning depends on which variables and model were used. The record labels the sponsor's method ANCOVA but does not report the model covariates or other details needed to reconstruct it.

How should the p-values be read?

The recalculated comparisons each have p < 0.001. General: A p-value describes how incompatible the observed data, or more extreme data, are with a specified null model, assuming that model and its assumptions. It is not the probability that the null hypothesis is true, nor does it measure the size or clinical importance of a difference. The registry record does not identify an adjustment for multiple comparisons, so the posted p-values should not be treated as multiplicity-adjusted.

The sponsor's result is reported as an ANCOVA with an Odds Ratio (OR) of 37.1 and p < .001. Its parameter label differs from the continuous mean outcome summaries, and the registry record does not explain the contrast or coding behind that value. The sponsor's result cannot be directly converted into either recalculated mean difference from the posted information.

What does the confidence interval add?

General: A confidence interval gives a range of values compatible with a statistical procedure and the observed data under its assumptions. It communicates uncertainty around an estimate rather than only whether a null-value test crosses a conventional threshold. The unadjusted interval for paced breathing is 4.464 to 9.476, and for mindfulness it is 5.977 to 10.6. Both are expressed in RCMAS score units. They describe uncertainty for the unadjusted mean differences, not for the sponsor's ANCOVA result, for which no interval is posted.

General: The interval's interpretation relies on the calculation's assumptions, including how scores vary and how observations contribute to the estimate. The recalculations use the reported arm means, standard deviations, and group sizes. They are not a substitute for the trial's individual-participant analysis. The record does not report diagnostics, model checks, or additional details that would allow assessment of those assumptions.

Why might an adjusted model differ?

General: ANCOVA commonly compares outcome values between groups while accounting for covariates, often baseline measurements. Adjustment may change an estimate or its precision, depending on the data and model. However, the particular covariates, outcome coding, and contrast used for this trial's reported ANCOVA are not reported in the registry record. The posted OR of 37.1 consequently cannot be assumed to represent the same quantity as the recalculated unadjusted mean differences.

General: Standard deviations reflect variability among observed scores; standard errors reflect uncertainty in an estimated statistic. The record includes standard errors for arm means in the recalculation details, but standard errors and confidence intervals are not reported for the sponsor's ANCOVA value. No further statistical model, missing-data approach, or analysis-population definition is reported in the registry record. These gaps prevent a complete reconstruction of the sponsor analysis and limit comparison across the reported statistical summaries.

10. Confidence Intervals and Precision

The recalculated unadjusted mean difference for paced breathing is 6.97 RCMAS units, with a 95% confidence interval from 4.464 to 9.476. For mindfulness, the mean difference is 8.29 units, with a 95% confidence interval from 5.977 to 10.6. Both estimates compare an intervention-arm endpoint mean with the control endpoint mean, and positive values correspond to higher average anxiety scores in the intervention arm.

General: A confidence interval conveys the precision of an estimate by showing a range of values compatible with the data and the calculation's assumptions. It does not guarantee that the true value lies within the particular interval, nor does it address biases caused by design or measurement. The posted intervals concern recalculated, unadjusted mean differences only. They do not quantify the sponsor's ANCOVA result, which has no confidence interval in the registry record.

Both intervals exclude zero, indicating that the recalculated differences are statistically distinguishable from zero under the procedure used. That observation is not a measure of clinical importance. The registry record does not report a threshold for meaningful change, and the intervals do not establish whether an individual participant experienced a change. Their widths also reflect statistical uncertainty, not uncertainty about all possible sources of bias or the fit of the sponsor's model.

The reported arm standard deviations are 6.61 for paced breathing, 5.82 for mindfulness, and 8.28 for control. They show that individual scores varied within each arm, but do not reveal distribution shape or baseline variation. The registry record does not report confidence intervals for each arm mean or for the sponsor's OR of 37.1. Precision should therefore be judged from the posted intervals only for the recalculated comparisons, with the limitations of those unadjusted calculations in mind.

11. 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 figures are planning illustrations based on the observed effect, not the trial's original design assumptions. They give participants per arm for each comparison. The calculation assumes a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. It sets the effect to detect at the stated fraction of the observed effect. The original trial's sample-size justification and design assumptions are not reported in the registry record.

For each comparison, the 80% power column gives the illustrative number of participants per arm that would yield an 80% chance of detecting the specified effect under the calculation assumptions, if that effect and assumptions applied. The 90% power column gives the corresponding planning figure for a 90% chance. These are prospective planning concepts, not descriptions of what occurred in the trial. They are not observed power.

For paced breathing, the illustrations for 100% of the observed effect are 19 participants per arm for 80% power and 25 per arm for 90% power. Planning for 75% of the observed effect gives 33 and 44 participants per arm; planning for 50% gives 74 and 99. For mindfulness, the corresponding figures are 12 and 16 for 100% of the observed effect, 21 and 28 for 75%, and 47 and 62 for 50%.

Smaller effects generally require more participants to detect under otherwise similar assumptions, which is why the lower-effect planning rows have larger figures. These calculations do not account for the sponsor's adjusted model, possible missing data, or departures from the stated assumptions. They should be read as illustrations based on observed estimates, which can be uncertain, and not as evidence that the completed trial had a particular probability of finding a result.

12. 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 = 6.970; pooled standard deviation σ = 7.541.
2. n = 2 × (1.96 + 0.842)² × 7.541² / 6.970² = 18.4, rounded up to 19 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 <- 6.97                      # observed difference in means
sigma <- 7.54105613372161                     # 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(6988800)
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 = 19 (80% power), 25 (90% power)
 75% of observed effect: n per arm = 33 (80% power), 44 (90% power)
 50% of observed effect: n per arm = 74 (80% power), 99 (90% power)
power.t.test: 19.4 
Simulated power at n = 19 per arm: 0.790 (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.

13. Analyses Reported by the Sponsor

The sponsor's reported analysis is an ANCOVA across the three posted groups. The result is labeled Odds Ratio (OR), with a value of 37.1 and p < .001. The registry record does not report a confidence interval for this estimate or specify the outcome coding, contrast, or covariates used in the analysis.

The recalculated comparisons are different: they are unadjusted mean differences in RCMAS scores, formed from the posted group means, standard deviations, and group sizes. The paced-breathing estimate is 6.97, and the mindfulness estimate is 8.29; their respective confidence intervals and p-values describe these unadjusted calculations. An odds ratio and a difference in continuous means are different statistical quantities, so the reported ANCOVA result cannot be directly compared numerically with either mean difference based on the registry record.

The record does not mark a discrepancy between the sponsor's result and the recalculations. That does not resolve the unexplained difference in parameter labels. The sponsor's own analysis should be read as reported, while recognizing that its interpretation is limited by the missing definition and interval. The recalculations provide a separate, transparent comparison of the posted summary statistics, not a replacement for or reconstruction of the sponsor's analysis.

14. Multiplicity, Missing Data and Analysis Populations

The registry record lists three outcome measures and three analyses, but no secondary outcomes are posted. It does not describe a multiplicity adjustment, a hierarchy of outcomes, or a prespecified testing strategy. The recalculated comparisons include separate tests of paced breathing versus control and mindfulness versus control, each reported with p < 0.001. Without a reported multiplicity plan, those p-values should be understood as unadjusted rather than as evidence that family-wise error was controlled.

The primary outcome description specifies measurement from enrollment to the end of treatment at 12 weeks. However, the posted arm means and standard deviations do not include baseline values or a clear statement that the endpoint values represent change from baseline. The registry record does not report a missing-data method, the amount or pattern of missing outcome data, or how participants with incomplete measurements were treated.

The analysis populations are also not defined. The record does not state whether the posted results use all randomized participants, those who completed treatment, or another population. It does not report adherence, withdrawals, exclusions, or deviations from assigned intervention. These omissions make it difficult to assess whether the reported endpoint comparisons preserve the benefits of randomization or could be affected by missingness or selection.

The sponsor's ANCOVA is identified by method but not by model details. Covariates, the modeled outcome, the contrast, and the handling of missing values are not reported in the registry record. The reported OR of 37.1 also lacks a confidence interval. Consequently, the adjusted result cannot be fully evaluated or reconciled with the unadjusted continuous-outcome summaries. These are reporting limitations; they do not establish that an analysis was or was not performed beyond what the registry record states.

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 serious adverse event entries report zero affected participants in the paced-breathing arm, zero in the mindfulness arm, and zero in control. The number at risk for serious events is listed as 64, 77, and 72 in those respective arms. The record also lists zero deaths in each arm.

The other adverse event entries likewise report zero affected participants in each arm, with the same corresponding numbers at risk: 64, 77, and 72. No top serious event terms are listed. These entries describe what the registry record reports; they do not establish that no adverse events occurred outside the recorded categories or observation period.

The registry record does not describe adverse-event collection procedures, event definitions, follow-up duration for safety, or whether events were actively solicited. It also does not provide event-level narratives. A zero count in the posted entries is therefore a statement about the recorded results, not a guarantee of absence of risk. The information is not a basis for medical advice or for conclusions about safety beyond the reported trial record.

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

The posted endpoint means show higher average RCMAS scores in both intervention arms than in control at the stated endpoint. Because the scale's higher scores indicate greater anxiety, the descriptive direction is toward higher, not lower, anxiety scores in the intervention groups. The recalculated unadjusted mean differences are positive, and both confidence intervals exclude zero. The posted p-values for these recalculations are p < 0.001.

These observations do not establish that either intervention caused the differences. The record does not report baseline score summaries, change-from-baseline results, an analysis population, or a missing-data approach. The sponsor's result is an ANCOVA labeled as an odds ratio, without a confidence interval or sufficient detail to interpret its relationship to the continuous score summaries. No conclusion about the reasons for the observed differences can be drawn from these summaries alone.

Statistical evidence against a zero mean difference is not equivalent to clinical importance. The record does not supply a minimum important difference or a threshold for meaningful change on the RCMAS. Group means also cannot establish what happened to any individual participant. The reported endpoint is a self-report measure; the registry describes the instrument and its Arabic version but does not provide further information about measurement conditions or participant-level responses.

The registry record describes randomized, double-masked allocation, but details of implementation are not reported. The completed status and reported group results do not remove uncertainty about trial conduct, missing outcomes, model specification, or generalizability. The record does not include secondary posted outcomes, so the interpretation is limited to the primary outcome summaries and the sponsor analysis described. These findings should be understood as a statistical account of the posted trial data, not as clinical advice or a general conclusion about breathing interventions.

17. Why This Trial Matters Statistically

This trial illustrates why the direction of an outcome scale must be checked before interpreting a difference. The RCMAS score is higher when anxiety is greater. In this record, the recalculated intervention-minus-control mean differences are positive, so a statistically clear difference does not mean an improvement in the outcome. Significance and direction answer different questions.

It also illustrates the value of keeping adjusted and unadjusted analyses distinct. The recalculations compare continuous group means, while the sponsor reports an ANCOVA result labeled as an odds ratio. Because the registry record does not clarify the sponsor's outcome coding or contrast, those results cannot be treated as interchangeable. Clear descriptions of estimands, model terms, and confidence intervals are needed for readers to understand what an analysis estimates.

Precision and design planning are likewise separate. The posted confidence intervals quantify uncertainty for the recalculated unadjusted mean differences, while the sample-size figures are planning illustrations based on observed effects and stated assumptions. Neither supplies missing information about the original design justification. This distinction helps prevent retrospective planning calculations from being mistaken for observed power or proof of adequate design.

Finally, the record shows how important transparent reporting is for interpretation. Baseline summaries, missing-data handling, analysis populations, multiplicity procedures, and detailed adverse-event methods are not reported. Their absence limits the assessment of bias, reproducibility, and clinical meaning even when estimates and p-values are available. These are general statistical concerns brought into focus by the particular reporting gaps and endpoint direction in this trial.

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 trial-specific limitations arise from the registry information. The primary endpoint is described at the end of treatment at 12 weeks, but the record does not provide baseline RCMAS means or clarify whether the posted endpoint summaries are raw endpoint values or changes. The recalculated comparisons are consequently unadjusted comparisons of the posted group summaries, rather than analyses of change or baseline-adjusted estimates.

The sponsor's ANCOVA result is difficult to interpret alongside the continuous RCMAS summaries because it is labeled as an Odds Ratio (OR) and reported as 37.1, with no confidence interval. The record does not define the modeled outcome, coding, contrast, or covariates. The recalculations cannot resolve those omissions.

The registry record does not report the analysis population, exclusions, missing outcome data, missing-data method, treatment adherence, or protocol deviations. It also does not give details of allocation concealment or how double masking was implemented. The control description is incomplete, and the brief summary mentions a take-home application condition that does not appear as a separate arm in the posted outcome results. The reason for this difference is not reported in the registry record.

No secondary outcomes are posted, despite three outcome measures and three analyses being listed. A multiplicity strategy and a clinically meaningful difference threshold are not reported. Safety entries list no affected participants, but event definitions and ascertainment procedures are not reported. These gaps constrain interpretation of statistical reliability, clinical importance, and safety reporting. They do not establish that omitted procedures or analyses did not occur; they mean those details are not reported in the registry record.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: Musically-Guided Paced Breathing Improves Mental Health in War-Affected Adolescents — NCT06988800.
• Registry record last updated 2025-10-14; status last verified 2025-09.
• Results first posted 2025-10-14.
• 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

The registry record describes a completed, randomized, double-masked, parallel-group trial sponsored by Muvik Labs, with enrollment of 213. It compares guided paced-breathing and guided mindfulness audiovisual interventions with control in the posted primary-outcome results. The primary endpoint is the RCMAS, measured from enrollment to the end of treatment at 12 weeks, with higher scores indicating greater anxiety.

Posted means are 24.88 for paced breathing, 26.2 for mindfulness, and 17.91 for control. Recalculated unadjusted mean differences versus control are 6.97 and 8.29, respectively, with both p-values reported as p < 0.001. The sponsor's ANCOVA is reported as an odds ratio of 37.1 with p < .001, but no confidence interval or interpretive model detail is given.

The record lists zero serious and other adverse events in each arm and zero deaths. Important analysis details, including missing-data handling and analysis populations, are not reported in the registry record.