A Prospective Study Investigating the Use of Relaxation Prior to Medical Procedures.: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for A Prospective Study Investigating the Use of Relaxation Prior to Medical Procedures. (NCT02690194), a randomized na study. The primary outcome is Pre-therapy/Pre-procedure Stress Level Measured by Blood Pressure.

2. Clinical Question

The study also describes a secondary question about whether prior stress and anxiety are associated with perceived pain after the procedure. Pain is listed as an outcome assessed with the Wong-Baker FACES Pain Rating Scale. The record does not report results for this question, so it cannot establish the direction, size, or precision of any association.

3. Trial Design

This is a prospective, randomized, single-masked, parallel-group study. The registry lists enrollment of 54 and marks the study as completed. Its stated purpose was to investigate Buddhify relaxation therapy in relation to stress and anxiety before medical procedures, as well as the relationship between pre-procedure stress and anxiety and post-procedure perceived pain.

The arm descriptions contain three group labels: Placebo Group, Experimental (Buddhify) Group, and Control Group. The intervention list names Placebo Group and Buddhify Therapy. The record does not fully reconcile these lists or describe how participants were allocated among all three described groups. It also does not state who was masked, what information was masked, or how masking was maintained. The term single-masked is recorded, but its operational meaning is not reported in the registry record.

For the placebo and Buddhify descriptions, measurements are taken before and after the session and before the procedure. Those descriptions then include the procedure and a post-procedure pain rating. The control description lists measurements before the procedure and a post-procedure pain rating, without a therapy session in its sequence. Listed measurements include blood pressure, pulse, respiration rate, and State-Trait Anxiety Inventory scores.

The record gives a start date of 2015-08 and a primary completion date of 2017-01-10. It does not report the intended allocation ratio, the randomization sequence method, concealment procedures, eligibility criteria, participant flow, or group-specific enrollment. The record also does not report protocol details sufficient to determine whether the three group descriptions correspond to three randomized arms or how the intervention labels map onto them.

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: Control group data was not analyzed for all measures

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.

Population: For the control group there were no post-therapy/pre-procedure data collected because there was no therapy for the control group.

6. Primary Endpoint

The registry lists the primary outcome as Pre-therapy/Pre-procedure Stress Level Measured by Blood Pressure, measured over Pre-therapy/pre-procedure.

The registered primary outcome is pre-therapy/pre-procedure stress measured by blood pressure in mmHg. It is specified as a mean with standard deviation, and its timeframe is pre-therapy/pre-procedure. Blood pressure is used in this study as a physiological measure related to stress; the record does not give a threshold or explain how blood pressure is translated into a stress level.

A measurement taken before therapy and before the procedure describes participants’ status at that point. By itself, it does not measure change after relaxation therapy or establish a contrast between study groups. To evaluate change following a session, an analysis would need to use measurements at relevant time points and specify how those measurements are compared. The registry lists post-therapy/pre-procedure changes in blood pressure, pulse, respiration rate, and anxiety among secondary outcomes, but does not report analyzed estimates for them.

The registry entry does not report a numeric primary outcome result, a group-specific mean, a standard deviation, a treatment contrast, or a confidence interval. It also does not give an analysis population or clarify how the registered baseline-timed outcome was intended to address the primary aim of investigating reductions in stress and anxiety. Consequently, the endpoint definition can be described, but the magnitude and precision of any intervention-related change cannot be assessed from the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry characterizes the primary outcome as a continuous measure summarized by a mean and standard deviation. A mean describes the center of a set of measurements, while a standard deviation describes how spread out individual measurements are around that mean. For blood pressure, the recorded unit is mmHg. The registry does not report the actual means or standard deviations, so these descriptive quantities cannot be interpreted for the study groups.

What would a treatment contrast represent?

In a randomized parallel-group trial, a treatment contrast generally compares outcomes between groups assigned to different study conditions. The precise contrast depends on the outcome, measurement time, analysis population, and statistical model. For this study, possible questions could concern post-session measurements, changes from before to after a session, or post-procedure pain. These are not interchangeable. The registry does not state which contrast or model was used for its primary analysis, and it reports no treatment-effect estimate.

A before-and-after change is a comparison of measurements taken at different times for the same participant. A between-group comparison asks whether the pattern differs across assigned groups. Both can be useful, but each answers a different question. A change observed within one group does not by itself show that the intervention caused that change; the comparison with an appropriate control condition is relevant to estimating an intervention effect. The record describes multiple measurement times for the placebo and Buddhify groups and lists a change outcome, but does not report results or specify the analysis approach.

How should uncertainty be described?

A confidence interval is a range of values compatible with the observed data under a specified statistical method. It communicates the precision of an estimate and the range of effects that remain plausible under that method. A p-value, when reported, quantifies how unusual the observed data would be under a specified null model; it is not a measure of the size or importance of an effect. Neither a confidence interval nor a p-value is reported for the registered primary outcome. No claim about statistical significance or precision can therefore be drawn from the registry entry.

Randomization is intended to make assigned groups comparable on average with respect to factors known and unknown at the time of assignment. It does not guarantee that groups are identical, especially in a study with limited enrollment, and it does not remove the need to report how allocation was generated, how participants flowed through the study, and how outcomes were analyzed. The record labels the study randomized but does not report the randomization method, allocation concealment, or group-specific enrollment.

What does masking contribute?

Masking can reduce the influence of expectations on participant responses, care, or outcome assessment, depending on who is masked and what information is concealed. This may be particularly relevant for self-reported anxiety or pain ratings. The record labels the design single-masked but does not identify the masked party or describe the masking procedure. The label alone is not enough to assess how well measurement or reporting could have been protected from expectations.

Blood pressure, pulse, and respiration rate are physiological measurements, while the State-Trait Anxiety Inventory and Wong-Baker FACES Pain Rating Scale are reported measures. Each type of outcome has its own measurement properties and potential sources of variability. The registry names the instruments and measures but does not report administration details, scoring rules, assessor training, or reliability information. No assumptions about those procedures can be made from the entry.

Why do multiple outcomes matter?

When a study evaluates several outcomes, time points, or contrasts, interpreting isolated results can be difficult. Multiplicity refers to the increased chance of finding an apparently unusual result when many statistical tests are performed. Statistical plans may address this by identifying a primary comparison in advance, adjusting inference, or describing secondary analyses as exploratory. The registry lists 14 outcome measures and zero analyses, and indicates that the primary outcome has several categories or time points rather than one reported comparison. It does not report a multiplicity strategy or a finalized statistical analysis plan.

Blood pressure, pulse, respiration rate, anxiety, pain, and the listed recent eating, drinking, and exercise measures represent different variables and questions. Their inclusion does not establish which were prespecified for confirmatory testing, how they were scored, or whether any adjustment was used. Those details are not reported in the registry record. As a result, there is no basis in the registry entry for ranking unreported findings or treating any potential secondary result as confirmatory.

Why do distributional assumptions matter?

Statistical models make assumptions about the data, such as the form of outcome distributions, the relationship between observations, or the way variability changes across groups. For a continuous outcome analyzed through means, analysts commonly assess whether a model’s assumptions are reasonable. When data are strongly skewed or contain influential extreme values, a mean-based analysis may not adequately represent the data; alternative summaries or models may be considered. These are general statistical considerations, not reported methods or findings from this study.

Repeated measurements on the same participant are related rather than independent. Analyses that use measurements across time should account for that within-person relationship. The registry lists pre- and post-session measurements for some groups, but does not report whether repeated-measures methods were used, how missing measurements were handled, or whether the analysis used change scores or a model of measurements over time.

What can sample-size planning show?

Sample-size calculations are planning tools that depend on assumptions about the target effect, variability, significance level, power, allocation, and analysis method. They do not show the observed effect or prove that a completed study had adequate precision. The registry record does not report a sample-size justification or the assumptions used when enrollment was planned. Any planning illustration associated with the study should therefore be distinguished from the trial’s own design rationale and from observed results. A calculation based on an observed effect is not observed power and cannot substitute for a confidence interval around an actual estimate.

The registry’s description of the outcome, design, and enrollment permits a limited account of the intended research question. It does not provide the data or analysis details needed to reproduce an estimate. Statistical interpretation should consequently remain descriptive: the record specifies what the investigators intended to measure, but does not report the quantitative treatment comparisons or their uncertainty.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists 14 outcome measures, including blood pressure, pulse, respiration rate, anxiety, perceived pain, and recent eating, drinking, and exercise measures. It reports zero analyses. The registry entry also indicates that the primary outcome has several categories or time points and was not reduced to one comparison. No multiplicity procedure, hierarchy of hypotheses, or specification of confirmatory versus exploratory outcomes is reported in the registry record.

When many outcomes or time points are examined, the chance of a seemingly notable result can increase. A statistical plan may address this by defining a primary contrast, adjusting for multiple testing, or interpreting secondary analyses as exploratory. The record does not state whether any such approach was used. Because no estimates or tests are reported, there is no finding to assess for multiplicity.

Missing-data handling is not reported in the registry record. The entry does not state how many participants completed each measurement, whether any outcomes were unavailable, why data might be missing, or whether imputation or another method was used. The listed enrollment of 54 does not establish the number included in any particular outcome analysis. Group-specific analysis populations and participant flow are also not reported.

The registry record does not identify an intention-to-treat, per-protocol, or other analysis population. These choices affect which participants contribute to an estimate and how the randomized comparison is interpreted. Without a stated population and missing-data approach, the potential influence of incomplete outcome data cannot be evaluated.

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

The record establishes that a prospective randomized, single-masked, parallel-group study was conducted to investigate relaxation before medical procedures. It lists Buddhify therapy and a placebo condition, and describes a control group. It also specifies blood pressure before therapy and the procedure as the primary outcome, alongside several secondary measures. These details describe the intended study questions and measurement sequence.

The record does not report the primary outcome result or analyzed comparisons for the listed secondary outcomes. It therefore does not show the size or direction of any change in blood pressure, anxiety, pulse, respiration rate, or perceived pain. No confidence intervals or p-values are reported, so the precision of a treatment estimate cannot be assessed. The study’s completed status and enrollment of 54 are not substitutes for outcome results.

The primary outcome timing also limits what can be inferred from its definition: a pre-therapy/pre-procedure measurement is a measure before the therapy session, not evidence of a post-session response. The record separately lists changes after therapy and before the procedure, but gives no findings for those measures. The relationship between pre-procedure stress or anxiety and post-procedure pain is also an intended secondary question, not a reported result.

The record lists zero adverse events, serious events, and deaths in the adverse-event fields for the described groups. These entries do not establish that no adverse effects occurred, because the record does not describe how events were collected, defined, or monitored. Nor do these entries provide a comparative assessment of safety.

Accordingly, the registry information supports a description of the trial’s design and planned measurements, but not a conclusion about whether the intervention changed an outcome, how large any change was, or how precisely it was estimated. Such conclusions require reported outcome data and analysis details that are not reported in the registry record.

12. Why This Trial Matters Statistically

This study raises a useful statistical distinction between a research aim and the outcome as registered. The stated primary aim concerns reducing stress and anxiety, while the registered primary measure is blood pressure taken before therapy and before the procedure. A measure collected before an intervention can characterize participants’ initial state, but an intervention effect requires an outcome contrast that captures what happened after the intervention relative to an appropriate comparator. The entry lists post-session change measures, yet does not report their analyses.

The design also draws attention to how comparator groups should be described. The registry names a placebo group and a Buddhify intervention, while the arm descriptions additionally include a control group. Clear mapping among allocation, intervention, and analysis groups is essential for understanding what a treatment contrast means. The available descriptions do not fully clarify that mapping.

Stress and anxiety are assessed alongside physiological measures and post-procedure pain. These variables may relate to one another, but they represent different outcomes and require distinct estimands and analyses. A study can ask whether a session changes a measure, whether groups differ after a session, and whether pre-procedure state is associated with later pain; those questions should not be conflated.

Finally, the absence of reported analyses illustrates why enrollment and completion status alone are insufficient for statistical interpretation. Group-specific results, estimates of uncertainty, participant flow, missing-data procedures, and multiplicity decisions are needed to judge what the data support. In this registry record, those details are not reported, so the statistical contribution is primarily the description of a planned measurement framework rather than a quantified treatment comparison.

13. 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 registry record leaves several trial-specific details unclear. It lists three group descriptions—Placebo Group, Experimental (Buddhify) Group, and Control Group—but names only Placebo Group and Buddhify Therapy in the intervention list. It does not fully explain whether all three descriptions correspond to randomized groups or how each group maps to the interventions. This prevents a clear reconstruction of the intended between-group comparisons.

The registered primary outcome is a pre-therapy/pre-procedure blood pressure measure, whereas the stated primary aim is to investigate reductions in stress and anxiety. The record also lists post-therapy/pre-procedure change outcomes. It does not explain how the primary endpoint was intended to address the primary aim, which time point or contrast was primary, or how outcomes with several categories or time points were to be reduced to a single analysis.

There are no reported outcome estimates or analyses. The record does not give group-specific means, standard deviations, effect estimates, confidence intervals, p-values, or analysis populations. It also does not report participant flow, group sizes, missing-data procedures, the randomization method, allocation concealment, the identity of the masked party, or the statistical analysis plan. These omissions prevent assessment of precision, attrition, analytic choices, and the risk of selective emphasis.

Although zero adverse events are recorded for each listed group, the record does not describe event definitions, collection methods, or follow-up. The recorded zeros therefore cannot establish the completeness of safety monitoring. These limitations concern what the registry entry reports; they do not establish what may have been documented elsewhere.

14. Related Tutorials

15. Related Statistical Calculators

16. Sources

• ClinicalTrials.gov: A Prospective Study Investigating the Use of Relaxation Prior to Medical Procedures. — NCT02690194.
• Registry record last updated 2018-12-21; status last verified 2018-12.
• Results first posted 2018-12-21.
• 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.

17. Record Summary

NCT02690194 is a completed prospective study titled “A Prospective Study Investigating the Use of Relaxation Prior to Medical Procedures.” The registry classifies it as randomized, single-masked, and parallel, with enrollment of 54. It lists Buddhify therapy and a placebo group, while the arm descriptions also include a control group.

The primary outcome is mean blood pressure in mmHg measured before therapy and before the procedure. The study description also identifies post-session measures of blood pressure, pulse, respiration rate, and anxiety, as well as post-procedure pain and other secondary outcomes. The stated aims concern relaxation therapy’s relationship to stress and anxiety and the relationship between prior stress and anxiety and perceived pain.

The registry lists 14 outcome measures and zero analyses. It does not report analyzed outcome results, effect estimates, uncertainty intervals, participant flow, or a statistical analysis plan. The record therefore describes the study’s design and measurement aims but does not provide a quantitative basis for interpreting intervention effects.