Impact of Mindfulness Based Stress Reduction on Anxiety, Depression and QOL in Women With Intrauterine Adhesion.: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Impact of Mindfulness Based Stress Reduction on Anxiety, Depression and QOL in Women With Intrauterine Adhesion. (NCT02746679), a randomized na study. The primary outcome is The Zung Self-Rating Anxiety Scale Scores Before and After the Intervention.

2. Clinical Question

The question is whether anxiety scores changed across the measurement occasions in women assigned to MBSR compared with women assigned to the wait-list control group. The registry describes the study as randomized, with parallel groups and quadruple masking. It does not report the details of how the allocation sequence was generated or how masking was implemented.

The record also lists depression and quality of life among the study aims, alongside secondary measurements related to menstruation, endometrial thickness, and intrauterine adhesions. These are distinct outcomes and should not be treated as interchangeable measures of anxiety. The posted record does not provide outcome values or a single estimate of the MBSR-versus-control difference for the primary anxiety outcome. Therefore, the clinical question can be described from the design and outcome definitions, but the size and precision of any group difference cannot be assessed from the registry record.

3. Trial Design

The study is registered as a randomized, parallel-group trial with quadruple masking. Its enrollment is recorded as 226, and its status is completed. The record gives a start date of 2015-01 and a primary completion date of 2015-11. It lists the condition as Asherman Syndrome and identifies MBSR as the intervention.

Participants assigned to the MBSR group were offered eight weekly sessions, each lasting 2.5 hours, on consecutive weeks. The description says the therapist took part in the mindfulness exercises with the group. Participants assigned to the wait-list control group did not receive MBSR during the 8 weeks when the MBSR group was engaged in the program; they received conventional therapy. The record does not provide further detail about the content of conventional therapy or about what happened to the wait-list group after that period.

The primary outcome is described as Zung Self-Rating Anxiety Scale scores before and after the intervention, with baseline and 8 weeks given as the measurement timeframe. The record also lists secondary outcomes involving depression scores, physical and other quality-of-life dimensions, endometrial thickness, self-rated menstruation, and hysteroscopy findings at follow-up. It lists 13 outcome measures and 13 analyses, but does not supply a complete account of how those analyses were specified or conducted.

Although randomization and masking are recorded, the sequence-generation method, allocation concealment, and practical masking procedures are not reported in the registry record. The record also does not describe a sample-size justification, the analysis population, or how participant withdrawals and missing measurements were handled. Those omissions limit assessment of the methods beyond the broad design features and intervention descriptions recorded.

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: A total of 226 patients with IUA were recruited into present study within 12 months. Of them, 10 met the exclusion criteria and 55 patients refused to participate in this study. Finally, 161 patients were randomized into MBSR group (n=80) and wait-list group (n=81).

Overall Study

Reasons for not completing this period:

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 The Zung Self-Rating Anxiety Scale Scores Before and After the Intervention, measured over Baseline and 8 weeks.

The stated primary endpoint is the Zung Self-Rating Anxiety Scale score before and after the intervention, with measurements at baseline and 8 weeks. The record describes the instrument as having 20 questions. Each question is scored from 1 to 4, and the raw score ranges from 20 to 80. It says the raw score is multiplied by 1.25 and the integer part is used as the standard score. The record describes severity categories based on standard scores, including within normal range or no significant psychopathology, mild to moderate anxiety, severe anxiety, and a final category worded as extreme depression.

As a general measurement principle, a standardized questionnaire can give researchers a consistent way to record a self-reported construct across participants and assessment occasions. A score is not itself a diagnosis; its meaning depends on how the scale is scored and interpreted, and on the context in which it is used. For a randomized comparison, an analysis of change or of follow-up scores can help describe how the groups differed, depending on the specified statistical plan.

The registry identifies anxiety as the primary outcome but does not provide the primary outcome values or a single comparison estimate. It also flags that the outcome includes several categories or time points and was not reduced to one comparison. Consequently, the listed scale description clarifies what was intended to be measured, but does not establish the observed magnitude, direction, or precision of a difference between groups.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What does randomization contribute?

In general, randomization is intended to make assigned groups comparable on average with respect to factors known and unknown at the time of assignment. That supports interpreting between-group differences as evidence about the assigned intervention, subject to the trial’s conduct, measurement, and analysis. The registry identifies this study as randomized, but does not report how the sequence was generated, how assignments were concealed, or whether the analysis followed the original assignments.

What does a parallel-group design mean?

In a parallel-group design, participants are assigned to one group and followed under that group’s assigned condition. Here, the record describes an MBSR group and a wait-list control group receiving conventional therapy. The MBSR program is described as eight weekly sessions, each 2.5 hours long. The record says the wait-list group did not receive MBSR during the 8 weeks in which the intervention group participated. It does not provide enough detail to characterize other aspects of care or follow-up.

How should the anxiety measure be understood?

The Zung Self-Rating Anxiety Scale is described as a 20-question measure, with each item scored from 1 to 4. The raw score range is 20 to 80. According to the record, the raw score is multiplied by 1.25 and the integer part is taken as the standard score. The registry lists categories for interpreting standard scores, including within normal range or no significant psychopathology, mild to moderate anxiety, severe anxiety, and a final category described as extreme depression. That wording is part of the registry description; the record does not explain it further.

As a general statistical concept, a continuous score retains more graded information than a categorization of scores. Categorizing a scale can make results easier to describe in some settings, but it can also discard distinctions between values within the same category. The registry does not provide enough result detail to determine whether its primary analyses used raw scores, standard scores, categories, or another representation.

Why does the comparison need a defined analysis?

A baseline and follow-up outcome can be analyzed in different ways, such as comparing follow-up scores between groups or comparing changes from baseline. These approaches answer related but not identical statistical questions and can rely on different assumptions. This is a general explanation, not a description of the analysis used in this trial: the registry record does not report which approach was prespecified or used for the primary outcome.

A reported group contrast would ideally be accompanied by an estimate of uncertainty. In general, a confidence interval gives a range of values compatible with the observed data and the statistical model. Its width reflects precision under that model. A p-value alone would not indicate the size of a difference, and neither a p-value nor an interval would resolve concerns about bias, missing data, or outcome selection. No primary estimate, confidence interval, or comparison-level p-value is reported in the registry record.

Why can variability matter?

As a general explanation, the standard deviation describes the spread of individual observations around a group mean. Greater variability can make a group mean less precise when the number of observations is held constant. If data vary more than a statistical model assumes, standard errors and tests based on that model may be unreliable; this is one reason analysts examine the distribution and fit of their model. The primary outcome is described as a mean with standard deviation, but actual means and standard deviations are not reported in the registry record.

What does masking tell readers?

The record labels masking as quadruple. Masking generally aims to limit the influence of knowledge about assignment on participants, care, outcome assessment, or analysis, depending on who is masked. The registry does not identify which parties were masked or describe how masking was maintained. The label therefore records a design feature but does not let readers evaluate its implementation.

What is the role of planning sample sizes?

Sample-size calculations are planning exercises based on assumptions about the effect to detect, variability, significance level, allocation, and analysis. They are not observed results and do not show whether the trial achieved a particular level of power. The record does not report its own sample-size justification or the assumptions used to plan enrollment. Any planning illustration should therefore be read as hypothetical rather than as a description of the original design or observed power.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists 13 outcome measures and 13 analyses. Alongside the primary anxiety scale, the secondary outcomes include depression, several dimensions of the 36-item Short-form Health Survey, endometrial thickness, menstruation assessed by visual analogue scale, and intrauterine adhesion findings at follow-up hysteroscopy. Testing multiple outcomes or multiple time points can raise a multiplicity concern: in general, the more comparisons considered, the greater the chance that at least one result appears notable by chance if no adjustment or prespecified hierarchy is used.

The statistical plan for multiplicity, including whether any outcomes were prioritized or adjustments were made, is not reported in the registry record. The record also flags that the primary outcome contains several categories or time points and was not reduced to one comparison. Without a clearly reported primary contrast and analysis plan, the intended role of each result cannot be fully assessed.

Information about missing observations is also not reported in the registry record. There is no description of the number of participants with outcome data at each assessment, reasons for missing measurements, or methods used to handle missingness. As a general principle, missing-data methods rely on assumptions about why data are absent, and different assumptions can affect estimates. The record does not provide the information needed to evaluate those assumptions.

The analysis populations are not reported in the registry record. It is therefore unclear whether analyses included all randomized participants, only participants with observed measurements, or another defined group. These omissions do not establish that analyses were inadequate; they mean that the reported record does not allow readers to assess the handling of multiplicity, missing data, or analysis populations.

11. Safety Results

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

Other (non-serious) adverse events

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

The registry’s adverse-event entries list 76 participants at risk in the MBSR group and 75 in the wait-list control group. For both groups, the number affected is recorded as 0 for serious adverse events and 0 for other adverse events. No serious adverse-event terms are listed. These figures describe the entries in the registry record and should not be interpreted as a complete account of all possible safety outcomes.

As a general statistical principle, an observed count of zero does not prove that the underlying risk is zero. The count is also specific to the people included in the recorded at-risk group, the event definitions, and the period of observation. The record does not provide details about how events were elicited, verified, or classified, nor does it specify the safety observation period in the adverse-event entry.

The death fields do not contain numeric counts, so deaths are not reported in the registry record. The zero affected counts should not be extended to outcomes that are not listed or to participants outside the recorded at-risk groups. The adverse-event information is therefore a limited description of reported counts, not a complete safety assessment.

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

The record describes a randomized comparison of an MBSR program with a wait-list control group receiving conventional therapy. It identifies the Zung Self-Rating Anxiety Scale as the primary outcome and gives baseline and 8 weeks as the assessment times. It also describes a range of secondary measurements. These details establish what the trial set out to compare and measure.

The record does not report a single primary outcome comparison, group score summaries, or an estimate with a measure of uncertainty. As a result, it cannot establish the direction, magnitude, or precision of a difference in anxiety scores. It also cannot show whether any difference was clinically important. The absence of a result in the registry record is not evidence that there was no difference; it is a limit on what can be concluded from the posted information.

In general, a randomized design can help estimate the effect of assignment to an intervention when the design is implemented and analyzed appropriately. Interpreting any estimate also requires understanding how participants were assigned, what outcomes were measured, how missing observations were handled, and which analyses were planned. Some of those details are not reported in the registry record.

The trial record likewise does not establish effects on depression, quality of life, menstruation, endometrial thickness, or adhesion findings, because the numerical results for those outcomes are not reported in the registry record for this analysis. The adverse-event entries record zero affected participants in the listed categories, but do not provide enough detail to characterize safety comprehensively. No recommendation about treatment follows from these registry entries alone.

13. Why This Trial Matters Statistically

This trial is statistically informative as an example of how a clearly named research question can still be difficult to evaluate when outcome results and analysis details are not reported. The record identifies randomization, a parallel-group comparison, the intervention schedule, a control condition, and a primary anxiety measure. Those elements help readers understand the intended structure of the study.

At the same time, the registry flags that the primary outcome has several categories or time points and was not reduced to one comparison. Without a defined primary contrast and reported estimate, readers cannot assess the magnitude or precision of the result. This illustrates why a measurement description is not a substitute for a numerical comparison and why a prespecified analysis plan can help distinguish a primary finding from the many other outcomes that may be measured.

The record lists 13 outcome measures and 13 analyses, making the reporting of outcome priorities and multiplicity methods important for interpretation. It does not report whether adjustments were made. Likewise, details about missing data and analysis populations are not reported. These are common sources of uncertainty in clinical trial interpretation because analytic choices can affect which participants and comparisons contribute to an estimate.

The registry also shows why safety counts require context. Zero affected participants are recorded for the listed serious and other adverse-event categories, but the event-collection procedures and death counts are not reported. A count alone does not describe the completeness of monitoring or the precision of an underlying risk estimate.

In general, transparent reporting of methods, results, and uncertainty allows clinical researchers and statisticians to distinguish the question a trial asked from the conclusions its data support. In this record, the design and measurement framework are described more fully than the outcome results and analysis details.

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.

The principal limitation for interpreting this trial from its registry record is that a single primary outcome comparison is not reported. The record identifies the Zung Self-Rating Anxiety Scale and the baseline and 8-week measurement occasions, but does not provide group-level results, an estimated contrast, or a measure of uncertainty. The primary outcome is explicitly flagged as involving several categories or time points and not reduced to one comparison.

Important design and analysis details are also absent. The method of random sequence generation, allocation concealment, and implementation of quadruple masking are not reported in the registry record. The statistical analysis plan, sample-size justification, analysis populations, and handling of missing measurements are likewise not reported. These omissions limit assessment of potential bias and analytical choices.

The record lists 13 outcome measures and 13 analyses but does not describe a multiplicity strategy or explain how primary and secondary analyses were prioritized. Numerical results for the listed secondary outcomes are not reported in the registry record for this analysis, so their direction and precision cannot be evaluated.

The intervention and control descriptions are not complete accounts of all care. The MBSR program is described as eight weekly sessions lasting 2.5 hours each, while the control group received conventional therapy and did not receive MBSR during the 8-week intervention period. Further details about conventional therapy, adherence, and follow-up are not reported in the registry record.

The adverse-event entries give at-risk counts and zero affected counts for the specified categories, but do not describe ascertainment procedures or provide numeric death counts. These limitations mean that the registry information supports a description of the trial’s intended comparison, not a complete evaluation of efficacy or safety.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Impact of Mindfulness Based Stress Reduction on Anxiety, Depression and QOL in Women With Intrauterine Adhesion. — NCT02746679.
• Registry record last updated 2016-08-26; status last verified 2016-05.
• Results first posted 2016-08-26.
• 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.

18. Record Summary

The record describes a completed randomized, parallel-group trial with quadruple masking, enrollment of 226, and a focus on women with intrauterine adhesion. MBSR consisted of eight weekly sessions, each 2.5 hours long. The wait-list control group received conventional therapy and did not receive MBSR during the intervention group’s 8-week program.

The primary outcome was Zung Self-Rating Anxiety Scale scores at baseline and 8 weeks. The record lists 13 outcome measures and 13 analyses, including depression, quality-of-life dimensions, and other clinical measurements. It indicates that the primary outcome was not reduced to a single comparison. A primary estimate, uncertainty measure, analysis plan, sample-size justification, missing-data approach, and analysis populations are not reported in the registry record.

The adverse-event entries record zero affected participants for serious and other adverse events in the listed groups; numeric death counts are not reported. The available information therefore describes the design and intended measurements more clearly than the results.