This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Use of Aromatherapy to Reduce Symptom Burden (NCT05251337), a randomized phase 2 study. The primary outcome is Chemotherapy-induced Nausea, Vomiting, and Retching (CINVR) Symptoms at Baseline, 25 Hours, and 48 Hours.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT05251337 |
| Phase | Phase 2 |
| Condition | Anxiety, Chemotherapy-induced Nausea and Vomiting |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Single |
| Enrollment | 92 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Indiana University |
| Results posted | Yes |
2. Clinical Question
Population
Patients who have received a stem cell transplant. The primary outcome was specified for analysis only among participants in the nausea/vomiting intervention and control arms; the registry record does not report the number analyzed for that outcome.
Intervention
Inhaled aromatherapy delivered through patches. The intervention was selected according to the participant’s primary symptom of concern: lavender patches in the anxiety arm, and peppermint patches in the nausea/vomiting arm, with mandarin described as an alternative in some circumstance that is not fully stated in the registry record.
Comparator
Blank patches with no essential oil infusion, in separate anxiety and nausea/vomiting control arms. The registry record does not report the comparative outcome estimates.
Primary question
Among participants whose primary concern was nausea or vomiting, how did mean chemotherapy-induced nausea, vomiting, and retching symptom scores change from baseline to post-intervention assessments in the aromatherapy and blank-patch groups? The record names assessments at 24 and 48 hours in the timeframe, while the outcome title refers to 25 and 48 hours.
The study also addressed anxiety, and its listed secondary outcomes include satisfaction, medication administered for nausea/vomiting, and inpatient falls. Those outcomes do not replace the defined primary outcome, which was restricted to the nausea/vomiting arms. The record describes randomized allocation, but does not report how randomization was generated or concealed. It also does not identify which people were masked. Most importantly for interpreting the clinical question, the registry record does not report the primary outcome values or a treatment comparison. A study question and a completed status do not, by themselves, establish whether an intervention changed symptoms.
3. Trial Design
This is a completed phase 2 randomized trial with a parallel-group model and single masking. Enrollment is listed as 92. The record gives a start date of 2022-03-07 and a primary completion date of 2023-06-22. These are registry entries about the planned and recorded conduct of the trial, not evidence of an outcome effect.
The design separates participants according to their primary symptom concern and randomized assignment. The nausea/vomiting intervention arm used inhaled aromatherapy patches described as peppermint, or mandarin as an alternative under a condition whose wording is incomplete in the registry record. Its control arm used blank patches without essential oil infusion. The anxiety intervention arm used lavender patches, and its control arm also used blank patches. Thus, the listed arms do not represent one identical aroma compared against one identical control across all participants; the assigned intervention depends on symptom group.
The primary outcome population is narrower than the overall trial enrollment: the record specifies analysis only from the intervention and control nausea/vomiting arms. Enrollment should not be read as the number contributing to that analysis, because analyzed group sizes and participant flow are not reported in the registry record. Nor should the intervention-arm safety denominators be treated as the primary-outcome analysis sample sizes.
Single masking is recorded, but the masked party or parties are not reported in the registry record. Details of allocation sequence generation, concealment, adherence, and protocol deviations are also not reported. The registry record lists five outcome measures and three analyses, but does not give enough detail to reconstruct the analysis methods or the results. The listed trial status is completed; completion alone does not supply the missing outcome estimates.
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.
Overall Study
| Stage | Intervention - Nausea/Vomiting | Intervention - Anxiety | Control - Nausea/Vomiting | Control - Anxiety |
|---|---|---|---|---|
| STARTED | 24 | 21 | 26 | 21 |
| COMPLETED | 19 | 15 | 20 | 17 |
| NOT COMPLETED | 5 | 6 | 6 | 4 |
Analysis population for the primary outcome, as defined in the registry: Outcome measure was pre-specified to analyze data only from the "Intervention-Nausea/Vomiting" and "Control-Nausea/Vomiting" Arms
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.
| Characteristic | Unit | Intervention - Nausea/Vomiting | Intervention - Anxiety | Control - Nausea/Vomiting | Control - Anxiety | Total |
|---|---|---|---|---|---|---|
| Participants analysed | 24 | 21 | 26 | 21 | 92 | |
| Age, Continuous | Years | 55 (22 to 72) | 51 (24 to 79) | 52 (22 to 78) | 51 (21 to 70) | 52 (21 to 79) |
| Sex: Female, Male: Female | Participants | 17 | 16 | 10 | 12 | 55 |
| Sex: Female, Male: Male | Participants | 7 | 5 | 16 | 9 | 37 |
| Race/Ethnicity, Customized: Native American or American Indian | Participants | 0 | 0 | 0 | 0 | 0 |
| Race/Ethnicity, Customized: Asian or Pacific Islander | Participants | 0 | 0 | 1 | 0 | 1 |
| Race/Ethnicity, Customized: Latino | Participants | 0 | 1 | 0 | 0 | 1 |
| Race/Ethnicity, Customized: Black or African American | Participants | 4 | 3 | 3 | 2 | 12 |
| Race/Ethnicity, Customized: White/Non-Hispanic | Participants | 20 | 17 | 22 | 19 | 78 |
| Race/Ethnicity, Customized: Other | Participants | 0 | 0 | 0 | 0 | 0 |
| Race/Ethnicity, Customized: Prefer Not to Say | Participants | 0 | 0 | 0 | 0 | 0 |
| Transplant Type: Allogenic | Participants | 1 | 3 | 5 | 7 | 16 |
| Transplant Type: Autologous | Participants | 23 | 18 | 21 | 14 | 76 |
| Cancer Type: Leukemia | Participants | 1 | 3 | 4 | 4 | 12 |
| Cancer Type: Dendritic Cell | Participants | 0 | 0 | 1 | 0 | 1 |
| Cancer Type: Germ Cell Tumor | Participants | 3 | 2 | 4 | 1 | 10 |
| Cancer Type: Hodgkin's Disease | Participants | 0 | 3 | 0 | 3 | 6 |
| Cancer Type: Myelodysplastic Syndromes | Participants | 0 | 0 | 0 | 2 | 2 |
| Cancer Type: Multiple Myeloma | Participants | 20 | 13 | 16 | 11 | 60 |
| Cancer Type: Non-Hodgkin's Lymphoma | Participants | 0 | 0 | 1 | 0 | 1 |
| Chemotherapy Regimen: BEAM | Participants | 0 | 3 | 1 | 2 | 6 |
| Chemotherapy Regimen: Etoposide/Carboplatin | Participants | 3 | 2 | 4 | 1 | 10 |
| Chemotherapy Regimen: Fludarabine/Cytoxan/Total Body Irradiation | Participants | 0 | 0 | 1 | 0 | 1 |
| Chemotherapy Regimen: Fludarabine/Cytoxan | Participants | 0 | 0 | 1 | 3 | 4 |
| Chemotherapy Regimen: Melphalan | Participants | 20 | 13 | 16 | 11 | 60 |
| Chemotherapy Regimen: Thiotepa/Cytoxan | Participants | 1 | 3 | 2 | 4 | 10 |
| Chemotherapy Regimen: Triptycene/Cytoxan/Fludarabine | Participants | 0 | 0 | 1 | 0 | 1 |
6. Primary Endpoint
The registry lists the primary outcome as Chemotherapy-induced Nausea, Vomiting, and Retching (CINVR) Symptoms at Baseline, 25 Hours, and 48 Hours, measured over baseline (0 hours) and post-intervention (24, 48 hours).
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | score on a scale |
| Endpoint classification | Continuous Endpoint |
The primary endpoint concerns chemotherapy-induced nausea, vomiting, and retching, collectively measured with the Rhodes Index of Nausea, Vomiting and Retching. The instrument uses eight Likert-type items on a five-point scale. Items are scored from 0, representing the least distress, to 4, representing the most distress; specified items are reverse-coded before an overall score is calculated. The overall score ranges from 0 to 32, with higher values indicating greater symptom burden.
This measure is relevant because it captures several related gastrointestinal symptoms rather than nausea alone. It also combines symptom experience, occurrence, and distress in its item structure. The record says subscales are calculated for symptom experience, occurrence, and distress for nausea, vomiting, and retching. The subscale description is cut off in the registry record, so the full subscale ranges and details are not available there.
The endpoint is summarized as a mean with standard deviation. The stated timeframe is baseline and post-intervention at 24 and 48 hours, while the outcome title says baseline, 25 hours, and 48 hours. This timing difference is not resolved in the registry record. No mean scores, standard deviations, changes, or comparative estimates are reported, so the endpoint definition can be described but its observed course cannot be evaluated from the record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies the trial as completed and specifies a primary symptom measure, but it does not report the primary-outcome data. There are no reported group means, standard deviations, between-group contrasts, confidence intervals, or p-values for the nausea/vomiting endpoint. Consequently, the posted information does not establish the direction, size, or precision of any difference between aromatherapy patches and blank patches. No conclusion about symptom change should be drawn from the study title, the intervention rationale, or the completed status.
The outcome is a repeated assessment: baseline and post-intervention measurements are named. In general, repeated measurements can be described as scores at each time, change from baseline, or a comparison of trajectories over time. These approaches answer related but not identical questions. A post-intervention comparison may depend on baseline imbalance; a change comparison considers each group’s movement from its starting point; and a trajectory analysis uses the pattern across assessments. The registry record does not report which approach was used for the primary comparison.
The summary measure is a mean, with standard deviation describing variability among observations around that mean. A mean difference would express a contrast on the instrument’s score scale, but no such estimate is reported. A confidence interval, if reported, would convey the range of effect sizes compatible with the data under the analysis assumptions; no confidence interval for this endpoint is reported. Without an estimate and its uncertainty, the record cannot show whether the evidence is precise enough to distinguish a small effect from a larger one or from little difference.
The primary endpoint applies only to the nausea/vomiting arms. It should not be generalized automatically to the separate anxiety arms, which used a different essential oil and represent a different symptom concern. The record names anxiety as a condition and describes anxiety arms, but does not report anxiety outcome results. Likewise, listed secondary outcomes concerning satisfaction, medication, and falls do not provide a substitute for missing primary-outcome results.
Safety information is reported for two intervention groups, but it is not a comparative efficacy analysis and does not provide corresponding control-arm safety figures in the adverse-event listing. The serious-event counts therefore require a separate, limited reading described in the safety discussion. In general, adverse-event counts should be interpreted with their group denominators, event definitions, observation period, and comparator information in view. Several of those details are not reported in the registry record.
The appropriate statistical interpretation is therefore descriptive of the record rather than of treatment effect: the design and outcome are specified, but the primary comparative results are not reported in the registry record. The available material cannot support an estimate of benefit, lack of benefit, or precision for the principal symptom question.
9. Statistical Methods Explained
What does a mean summarize?
The primary endpoint is a continuous score summarized by a mean and standard deviation. In general, the mean describes the average score in a group, while the standard deviation describes how spread out individual scores are around that average. Neither statistic alone shows the difference between randomized groups. A group can have a mean that changes over time, but the comparative question concerns how outcomes differ between assigned groups, accounting for the chosen analysis and its uncertainty. The registry record does not report the means or standard deviations for the primary endpoint.
Why do repeated assessments matter?
Baseline and post-intervention assessments create a longitudinal outcome: measurements from the same participant are related rather than independent. In general, an analysis of such data should account for the within-participant relationship. An analyst might compare follow-up values between groups, compare changes from baseline, or model measurements across time. These methods target different summaries and can depend on assumptions about baseline values, time effects, and missing observations. The registry record does not report which method was used, whether baseline values were included in a model, or how repeated observations were handled.
There is also a timing wording issue. The outcome title refers to 25 hours, whereas the timeframe describes post-intervention assessments at 24 and 48 hours. The record does not clarify whether this reflects different assessment timing or a naming inconsistency. Timing matters because a score is interpretable relative to when it was collected, and a comparison over time needs clearly identified assessment points.
What does uncertainty add?
In general, an effect estimate describes the observed contrast, while a confidence interval describes its statistical uncertainty under the analysis assumptions. A narrow interval indicates greater precision than a wide interval, though precision does not itself establish clinical importance. A p-value addresses compatibility of the observed data with a specified null model; it does not measure effect size, the probability that a treatment works, or the importance of a result. The registry record does not report an effect estimate, confidence interval, or p-value for the primary outcome, so none of these aspects can be evaluated from the posted results.
What is the role of randomization?
In general, random assignment is intended to make groups comparable with respect to both measured and unmeasured baseline characteristics, on average, when the process is implemented and analyzed appropriately. Randomization does not guarantee identical groups in a particular trial, and it does not prevent bias from missing outcomes, departures from assignment, or outcome measurement. The registry record identifies the trial as randomized, but does not report the sequence-generation or concealment procedures, allocation balance, or participant flow. The degree to which these safeguards were implemented cannot be assessed from the record.
What does the scale mean for analysis?
The overall index is a bounded score from 0 to 32, and higher scores indicate greater symptom burden. It is built from Likert-type items and then treated in the registry as a continuous measure summarized by a mean and standard deviation. In general, treating a multi-item score this way makes it possible to summarize average differences on the instrument’s scale. It does not remove the need to examine distributional assumptions, floor or ceiling concentrations, or whether a mean adequately describes the group. These diagnostics and the analysis assumptions are not reported in the registry record.
Over-dispersion is a concern most often discussed for count outcomes, where variability exceeds what a simple count model expects. It is not a named feature of this continuous score endpoint, and the registry record does not identify a count-model analysis for the primary outcome. More generally, the appropriate model depends on the outcome’s scale and distribution; a statistical method should not be inferred from the summary measure alone.
What analysis details are unavailable?
The record does not report the primary statistical model, whether the comparison was adjusted, the handling of repeated measures, the planned contrast, or the treatment of missing values. It also does not report an analysis population definition beyond specifying that the primary outcome was pre-specified for the nausea/vomiting intervention and control arms. It is therefore not possible to determine whether all randomized participants in those arms were included, how participants with incomplete assessments were treated, or whether the analysis followed assigned group.
General statistical interpretation also depends on distinguishing a pre-specified analysis from exploratory analyses and accounting for multiple comparisons when many outcomes, time points, or contrasts are examined. The registry record lists five outcome measures and three analyses, but does not report the multiplicity strategy or enough analysis details to determine which tests or contrasts were confirmatory. No statistical plan, interim analysis approach, or sample-size justification is reported in the registry record. Any general explanation of these methods should not be mistaken for a description of procedures used in this trial.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists five outcome measures and three analyses. The primary symptom outcome includes more than one assessment time, and the study also lists secondary outcomes involving satisfaction, medication administered for nausea/vomiting, and inpatient falls. When investigators test multiple outcomes, time points, or contrasts, the chance of at least one apparently unusual finding can increase. In general, multiplicity procedures can control or otherwise address that issue, but the method and its scope must be specified to interpret reported p-values. The registry record does not report a multiplicity strategy, a hierarchy among outcomes, or which analyses were designated confirmatory.
The record does not report missing-data counts for the primary outcome, the reasons for missingness, or the method used to handle incomplete measurements. In general, missing observations can affect a longitudinal comparison when the likelihood of missingness is related to symptoms, treatment assignment, or other participant characteristics. Complete-case analysis, imputation, and model-based approaches make different assumptions; none should be attributed to this trial without documentation. Participant flow and the number contributing at each assessment are not reported in the registry record.
The primary outcome population is specified as the intervention and control nausea/vomiting arms, but the record does not explain whether the analysis included all randomized participants in those arms or only participants with observed endpoint data. It also does not report an intention-to-treat definition, a per-protocol population, or other analysis-population rules. Thus, the exact population underlying any primary estimate cannot be reconstructed. Since no primary result is reported, the consequences of missingness or multiplicity for the numerical findings cannot be assessed.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Intervention - Nausea/Vomiting | 0 | 24 | 0.0% |
| Intervention - Anxiety | 1 | 21 | 4.8% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Intervention - Nausea/Vomiting | 0 of 24 |
| Intervention - Anxiety | 0 of 21 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Intervention - Nausea/Vomiting | 9 of 24 |
| Intervention - Anxiety | 12 of 21 |
Most frequent serious adverse event terms
| Event term | Organ system | Intervention - Nausea/Vomiting | Intervention - Anxiety |
|---|---|---|---|
| Sepsis | Infections and infestations | 0 of 24 | 1 of 21 |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | 0 of 24 | 1 of 21 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Intervention - Nausea/Vomiting | Intervention - Anxiety |
|---|---|---|---|
| Pancytopenia | Immune system disorders | 6 of 24 | 4 of 21 |
| Diarrhea | Gastrointestinal disorders | 5 of 24 | 4 of 21 |
| Mucositis | Infections and infestations | 6 of 24 | 3 of 21 |
| Fatigue | General disorders | 3 of 24 | 6 of 21 |
| Neutropenic Fever | Immune system disorders | 5 of 24 | 3 of 21 |
| Nausea | Gastrointestinal disorders | 4 of 24 | 1 of 21 |
| Headache | Nervous system disorders | 2 of 24 | 2 of 21 |
| Vomiting | Gastrointestinal disorders | 3 of 24 | 1 of 21 |
| Dysuria | Renal and urinary disorders | 0 of 24 | 3 of 21 |
| Abdominal pain | Gastrointestinal disorders | 1 of 24 | 2 of 21 |
Serious events with the highest arm-level rate: sepsis (4.8%), respiratory failure (4.8%).
The adverse-event listing gives serious-event information for the two intervention groups. For Intervention - Nausea/Vomiting, 0 serious events are listed among 24 at risk; for Intervention - Anxiety, 1 serious event is listed among 21 at risk. Deaths are listed as 0 in both of these groups. These figures describe the registry entries for those groups and should not be read as estimates of comparative risk against the control arms.
The record also lists other adverse events for the intervention groups: 9 among 24 at risk in the nausea/vomiting group and 12 among 21 at risk in the anxiety group. The meaning of “other” and the event-collection window are not reported in the registry record. The adverse-event listing does not include control-group entries, so a comparison between aromatherapy and blank patches cannot be made from these figures. Group-specific exposure duration and the rules for counting events are also not stated.
Sepsis and respiratory failure are each listed among the top serious-event terms at 4.8%. The record does not specify the group attribution or event counts for these terms in the listing. They should not be combined with the group-level figures to infer a rate or comparative effect. Safety counts are descriptive registry information; interpretation requires consistent definitions, time at risk, complete group reporting, and context that the record does not provide.
12. What the Result Does, and Does Not, Mean
The record establishes that a randomized, parallel-group phase 2 trial was completed and that its primary symptom measure was defined in advance for participants assigned to the nausea/vomiting arms. It also describes inhaled essential-oil patches and blank-patch comparators, and gives the overall score direction: higher INVR scores indicate greater symptom burden. These details clarify the question the trial was designed to address.
The record does not report the primary outcome results. It therefore does not show whether mean symptom scores differed between the nausea/vomiting intervention and control groups, how scores changed from baseline, or how precise any comparison was. It cannot establish that aromatherapy reduced symptoms, nor can it establish that there was no effect. Absence of a reported estimate is not evidence of equivalence or evidence that groups had the same outcomes.
The distinction between the symptom groups also matters. The nausea/vomiting intervention is described as peppermint, with mandarin as an alternative under an incompletely stated condition, while the anxiety intervention is lavender. The primary outcome population is limited to the nausea/vomiting arms. Findings on that measure, if reported, would not automatically answer the separate anxiety question. The registry record does not report anxiety outcome results.
The enrollment figure is not an analyzed sample size. The record does not report primary-outcome participant counts by arm or at each assessment. Similarly, the intervention-arm adverse-event entries are not evidence of comparative safety because control-group adverse-event figures are absent from that listing. The completed status indicates the registry’s recorded trial status, not that all outcomes are publicly reported or that a specific clinical conclusion follows.
In general, a clinical result is most informative when its effect estimate, uncertainty, analysis population, and outcome timing are reported together. Those elements are not available for the primary comparison in the registry record. The meaning is consequently limited to the trial’s design and measurement plan, rather than a conclusion about comparative symptom outcomes.
13. Why This Trial Matters Statistically
This trial raises a useful statistical issue: symptom-focused studies may define different intervention and control arms according to participants’ primary concerns. Here, the anxiety and nausea/vomiting groups receive different essential oils, while the primary outcome analysis is restricted to the nausea/vomiting arms. Keeping the target population and contrast explicit is essential; combining all arms into a single treatment comparison would obscure which question the primary endpoint was intended to answer.
The endpoint is also repeated over time and bounded by the instrument’s scoring range. Clear reporting of assessment timing, group means, variability, between-group estimates, and uncertainty would allow readers to distinguish baseline symptom burden from post-intervention outcomes and to assess the precision of a comparison. The title’s reference to 25 hours and the timeframe’s reference to 24 hours make precise timepoint reporting especially relevant.
For biostatistical interpretation, this record illustrates the difference between a registered design and reported evidence. Randomization and a defined outcome establish an analytical framework, but they do not reveal the observed effect. Without outcome data and analysis details, readers cannot assess effect size, uncertainty, missing-data sensitivity, or how multiple outcomes were handled. Those are not minor presentation details: they determine what conclusions can be supported by the reported record.
The study also separates efficacy questions from safety summaries. Serious-event entries for intervention arms alone do not create a randomized safety comparison. Complete reporting by assigned group, with clear definitions and observation periods, is needed to interpret safety patterns alongside symptom outcomes. The statistical importance of this trial record lies in making those reporting requirements visible, while recognizing that the primary comparative results are not reported in the registry record.
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 largest limitation for interpretation is that primary-outcome results are not reported in the registry record. There are no group-level scores, treatment contrasts, uncertainty intervals, or significance tests to assess. The registry record also does not report participant counts analyzed at baseline or follow-up, participant flow, missing-data handling, or the analysis population beyond the specified nausea/vomiting arms. This prevents assessment of whether the outcome data represent the randomized groups as intended.
Several design and analysis details are unavailable. The record identifies single masking but does not say who was masked. It does not report how the allocation sequence was generated or concealed, adherence to the assigned patch, protocol deviations, the primary statistical model, or whether the analysis adjusted for baseline scores. The multiplicity plan and the approach to interim analyses are not reported in the registry record. No sample-size justification is reported there.
Endpoint reporting has two specific ambiguities. The title names a 25-hour assessment, whereas the timeframe names 24 hours, and the registry does not reconcile those descriptions. The endpoint description also ends partway through the list of subscale ranges, leaving the full subscale specification unavailable. In addition, the nausea/vomiting intervention description ends mid-sentence after introducing mandarin as an alternative, so the condition for that alternative is not fully reported.
The safety listing contains intervention-arm figures but no corresponding control-arm entries, and it does not define the “other” adverse-event category or state the event-collection period. These limitations constrain both comparative safety interpretation and assessment of how completely harms were captured. They are limitations of what the registry record reports; they do not establish what was or was not done outside the record.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Use of Aromatherapy to Reduce Symptom Burden — NCT05251337.
- Registry record last updated 2024-05-16; status last verified 2024-04.
- Results first posted 2024-05-16.
- 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.
Continue through the Clinical Biostats statistical pathway
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18. Record Summary
NCT05251337 is a completed randomized, parallel-group phase 2 trial sponsored by Indiana University, with single masking recorded and enrollment listed as 92. It studied inhaled aromatherapy patches in patients receiving stem cell transplantation, with intervention and blank-patch control arms for participants whose primary concern was nausea/vomiting or anxiety.
The primary measure was the Rhodes Index of Nausea, Vomiting and Retching, summarized as a mean and standard deviation. Higher overall scores indicate greater symptom burden. The primary outcome was specified for the nausea/vomiting arms only. Its title and timeframe differ on whether one assessment occurred at 25 or 24 hours.
The registry record does not report primary-outcome results, comparative estimates, or their uncertainty. It also does not report key analysis details, including missing-data handling and the multiplicity strategy. Adverse-event entries are given for intervention groups, without control-group entries in that listing. The available record therefore describes the study design and outcome definitions but does not permit evaluation of the primary treatment comparison.