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 Hypnotherapy With Audiofiles for Children and Adolescents With Disorders of Gut-brain Interactions in Sweden -a Feasibility Study (NCT06493097), a na na study. The primary outcome is Peds-QL-gastro.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT06493097 |
| Phase | NA |
| Condition | Self-hypnosis, Functional Bowel Disorder, Functional Abdominal Pain Syndrome |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 32 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Karolinska Institutet |
| Results posted | Yes |
2. Clinical Question
The study asks whether a Swedish-language, audio-file approach to gut-directed hypnotherapy is feasible for children and adolescents with disorders of gut-brain interaction, and aims to test its effect. It is a single-group feasibility study, so the record does not describe a separate control group or a randomized treatment comparison.
Population
Children and adolescents with disorders of gut-brain interaction in Sweden. Further eligibility details, including age limits and diagnostic criteria, are not reported in the registry record.
Intervention
Gut-directed hypnotherapy via audio files. Participants receive access to a website with information about the diagnosis and symptom mechanisms, and a self-hypnosis protocol with 5 age-adjusted audio files.
Comparator
No separate comparator is described. The study has a single-group design, so outcomes are not presented as a comparison with usual care, another treatment, or a control group.
Primary question
The primary measure is Peds-QL-gastro, a gastrointestinal symptom questionnaire scored from 0 to 100, with higher scores indicating a better outcome. It is scheduled for Week 0 before treatment and Week 12 after treatment.
The registry describes the work as a feasibility study that is intended to precede a larger randomized trial comparing psychological treatment options for this patient group. It does not report numerical primary-outcome results, so the record cannot establish the size or precision of any change in Peds-QL-gastro during this study.
3. Trial Design
This is a completed, single-group feasibility study sponsored by Karolinska Institutet. The registry lists an enrollment of 32 and describes the intervention as behavioral: gut-directed hypnotherapy delivered via audio files. The study start is recorded as 2023-10-01, and primary completion as 2024-06-30. Its phase is listed as NA.
Participants are described as receiving access to a website containing information about disorders of gut-brain interaction and mechanisms leading to symptoms. The website also provides a self-hypnosis treatment protocol with 5 age-adjusted audio files. The record does not specify the audio listening schedule, total treatment duration, or the amount of participant contact during treatment.
Allocation is listed as NA, masking as NONE, and the model as single group. No randomized allocation or concurrent control group is described. This means the design can document outcomes in the treated group, but it does not directly compare those outcomes with what would have happened under another treatment or without the intervention.
The registry identifies Week 0 before treatment and Week 12 after treatment as the primary outcome time points. It states that the post-treatment measurement must be completed within 2 weeks from the end of treatment. The duration of treatment itself is not reported in the registry record.
The study is framed as a feasibility step before a larger randomized trial comparing psychological treatments for this patient group. The registry does not report the feasibility criteria, a formal progression rule, or the specific measures used to judge feasibility. It also does not report a sample-size justification or a detailed statistical analysis plan.
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: Participants received the intervention within 4 weeks from enrollment, all participants received same intervention in this pilot study.
Overall Study
| Stage | Treatment With Hypnotherapy Audio Files |
|---|---|
| STARTED | 32 |
| COMPLETED | 25 |
| NOT COMPLETED | 7 |
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 | Treatment With Hypnotherapy Audio Files |
|---|---|---|
| Participants analysed | 32 | |
| Age, Categorical: <=18 years | Participants | 32 |
| Age, Categorical: Between 18 and 65 years | Participants | 0 |
| Age, Categorical: >=65 years | Participants | 0 |
| Sex: Female, Male: Female | Participants | 22 |
| Sex: Female, Male: Male | Participants | 10 |
| Race and Ethnicity Not Collected | Participants | — |
| Region of Enrollment: Sweden | Participants | 32 |
| Symtom duration >2 years | Participants | 24 |
| Diagnosis IBS (irritable bowel syndrome) | Participants | 22 |
| Diagnosis FAP-NOS (functional abdominal pain - not otherwise specified) | Participants | 5 |
| Diagnosis FD (functional dyspepsia) | Participants | 5 |
6. Primary Endpoint
The registry lists the primary outcome as Peds-QL-gastro, measured over Week 0 (pre) and 12 (post) of treatment. The post-treatment measurement must be finished within 2 weeks from end of treatment..
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | units on a scale |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is Peds-QL-gastro, described as a short questionnaire gastrointestinal symptom scale. It ranges from 0 to 100, and a higher score means a better outcome. The registry specifies the unit as units on a scale and describes the summary measure as a mean with standard deviation.
The measure is scheduled at Week 0 before treatment and Week 12 after treatment. The post-treatment questionnaire must be completed within 2 weeks from the end of treatment. The record does not report how the questionnaire is scored beyond its range and direction, or how missing questionnaire items are handled.
In general, a continuous scale can capture variation across participants rather than reducing responses to a simple yes-or-no outcome. A mean describes the group’s average score, while a standard deviation describes the spread of scores around that mean. These summaries can help readers understand both the central outcome and how much participants differ from one another.
The primary measure is relevant to the study because it addresses gastrointestinal symptoms and is assessed before and after the intervention. However, the registry record does not include the actual means, standard deviations, or change in score. It therefore does not show the magnitude or precision of the observed outcome on this measure.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry describes a completed feasibility study of audio-file hypnotherapy, with an enrollment of 32 and a single-group design. It specifies Peds-QL-gastro as the primary measure, assessed at Week 0 before treatment and Week 12 after treatment. The scale ranges from 0 to 100, and higher scores indicate a better outcome.
The registry record does not report numerical primary-outcome results. It gives no Peds-QL-gastro means, standard deviations, estimated change, confidence interval, or test result. It also lists no analyses. Consequently, the posted information does not permit an estimate of how much scores changed, how variable participant scores were, or how precisely any change was measured.
In general, a confidence interval describes a range of values compatible with an estimate under the statistical model used. Its width conveys precision: a wider interval indicates greater uncertainty. No confidence interval for the primary measure is reported in the registry record, so the precision of an outcome estimate cannot be assessed from this record.
The single-group design is important when interpreting any before-and-after results. Even if a group’s average score changed over time, a change alone would not establish that the intervention caused it. Without a concurrent comparator, changes could also reflect the natural course of symptoms, expectations, other care, measurement variation, or other influences. These are general considerations about single-group studies, not explanations of any observed result in this study.
The registry says the study aims to test both effect and feasibility, but the numerical results and feasibility findings are not reported in the registry record. The planned role of the study is to precede a larger randomized trial. That context makes it especially important not to treat this record as a controlled estimate of comparative treatment effects.
The safety summary records 32 participants at risk, with zero serious adverse events, zero other adverse events, and zero deaths. These are registry counts. They do not by themselves establish that no events occurred outside the recorded categories or observation period, and the record does not describe the event-monitoring procedures.
Overall, the registry supports a description of the study’s design, intervention, outcome measure, and recorded safety counts. It does not provide the outcome estimates needed to quantify change or to judge statistical uncertainty in Peds-QL-gastro.
9. Statistical Methods Explained
The registry identifies a continuous primary outcome summarized as a mean and standard deviation. It does not report an analysis result, a confidence interval, a hypothesis test, or a detailed analysis plan. The explanations below describe general statistical concepts relevant to this type of outcome; they do not imply that any particular analysis was used in this study.
What does a mean describe?
For a continuous questionnaire score, the mean is the arithmetic average across the participants included in the summary. It gives a measure of the group’s central score, but it does not show whether most participants had similar scores or whether individual responses varied widely. The registry specifies Peds-QL-gastro scores from 0 to 100, with higher values indicating a better outcome, but it does not report the group means at either assessment.
Why report a standard deviation?
In general, the standard deviation describes how spread out participant scores are around the mean. A small standard deviation indicates that scores tend to cluster more closely around the mean, while a larger one indicates more dispersion. It is not the same as the uncertainty around the mean: a standard deviation describes variation among participants, whereas a confidence interval for a mean describes uncertainty in estimating the group mean. Neither standard deviations nor confidence intervals for the primary endpoint are reported in the registry record.
How should repeated measurements be understood?
The endpoint schedule includes a measurement at Week 0 before treatment and another at Week 12 after treatment, with the post-treatment measure required within 2 weeks from treatment end. In general, repeated measurements allow investigators to examine how an outcome changes within the same participants over time. The analysis could be expressed as a change score or by another method, but the specific method is not reported in the registry record. It should not be assumed that a particular paired test, adjustment, or model was used.
In a single-group study, a within-group change is descriptive of what happened over time among observed participants. It does not isolate the effect of treatment from other explanations for change. A concurrent randomized comparison can help estimate differences between treatment strategies because it compares groups under a shared study period, but no such comparison is described for this feasibility study.
What does a confidence interval contribute?
In general, a confidence interval communicates the uncertainty around an estimated quantity, such as an average score or a difference between measurements. The interval’s width depends on the data and the statistical method. A point estimate without an interval can conceal substantial uncertainty; an interval is therefore useful for judging the range of effects compatible with the analysis. The registry record does not report a primary-outcome estimate or interval.
What is over-dispersion?
Over-dispersion is a general issue for outcomes modeled as counts or other data where observed variability is greater than the model expects. It can make standard errors too small if the model does not account for that extra variation. The primary endpoint in this study is a continuous questionnaire score, not a count outcome as described in the registry. The record does not identify a statistical model or report an over-dispersion assessment, so this concept should not be read as a feature of the reported analysis.
How should planning calculations be read?
General sample-size planning asks how much information a future study might need to detect a specified effect under stated assumptions. The registry’s planning assumptions describe a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; the effect to detect is expressed as a stated fraction of an observed effect. For time-to-event outcomes, the assumptions specify total events, while other outcomes are described in participants per arm.
Those assumptions concern a hypothetical two-arm planning illustration, not the observed design of this single-group feasibility study. The registry does not report the computed planning counts or the observed primary-outcome effect used for such an illustration. Any planning sample size is a future-study illustration, not observed power and not evidence that a treatment effect has been established.
What cannot be reconstructed?
The record does not report the statistical plan, analysis population, treatment of missing outcome data, model covariates, or whether any interim analysis was conducted. It also lists no analyses. Without these details and without numerical endpoint results, a reader cannot reconstruct an estimate, verify a test, or assess the assumptions underlying a reported inferential result.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 7 secondary outcomes, in addition to the primary Peds-QL-gastro measure. The secondary outcomes include pain frequency and intensity, stress, gastrointestinal symptom-related anxiety, GI symptom-specific anxiety, quality of life, and adequate relief. Multiple outcomes create a general multiplicity issue: when many hypotheses are tested, the chance of at least one apparently notable result can increase. Whether and how that concern was addressed is not reported in the registry record.
The record lists no analyses and does not describe a multiplicity adjustment, a hierarchy of outcomes, or which outcomes were intended to be confirmatory versus exploratory. It is therefore not possible to determine how results across the primary and secondary measures were planned to be interpreted.
Missing data are also relevant to a before-and-after outcome. Participants may have a baseline measure but no post-treatment measure, or may have incomplete questionnaire responses. The registry specifies the measurement schedule but does not report completion counts, reasons for missingness, imputation methods, or other missing-data procedures. The extent and handling of missing primary or secondary outcome data are not reported in the registry record.
The registry does not identify an analysis population, such as all enrolled participants or only those with measurements at both time points. It is therefore not possible to tell which participants would have contributed to an outcome summary. These omissions limit assessment of whether the available outcome data represent the enrolled group and how robust any results would be to missingness.
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 |
|---|---|---|---|
| Treatment With Hypnotherapy Audio Files | 0 | 32 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Treatment With Hypnotherapy Audio Files | 0 of 32 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Treatment With Hypnotherapy Audio Files | 0 of 32 |
The registry safety summary lists 32 participants at risk in the hypnotherapy audio-file group and records zero serious adverse events. It also records zero other adverse events and zero deaths. These figures are counts in the registry record; they are not a comparison with an untreated or alternative-treatment group.
A count of zero means that no events in the relevant category are recorded in this summary. It does not, by itself, establish that the intervention has no risks. Interpretation depends on how events were defined, how actively they were sought, the length of observation, and whether all participants were followed for safety. Those procedures and the safety follow-up duration are not reported in the registry record.
The group at risk is recorded as 32 for the serious and other adverse-event summaries. The record does not provide event definitions, severity grading details beyond the serious-event category, participant-level event descriptions, or a narrative about how safety information was collected. The figures should therefore be read as the posted counts, without inferring more about event ascertainment or risk than the registry documents.
12. What the Result Does, and Does Not, Mean
The registry record establishes that this was a completed, single-group feasibility study of gut-directed hypnotherapy delivered through audio files to children and adolescents with disorders of gut-brain interaction in Sweden. It describes a website with diagnostic information and a self-hypnosis protocol using 5 age-adjusted audio files. The primary measure is Peds-QL-gastro, assessed before treatment and after treatment.
What the record does not establish is the amount of change in the primary score. Numerical outcome estimates, their variability, and their precision are not reported. Without those results, the statistical size and uncertainty of any change cannot be assessed. The registry also does not report the stated feasibility findings or criteria used to judge feasibility.
Even if a within-group change were available, the design would not, by itself, distinguish an intervention effect from changes due to time, other care, expectations, or other influences. The absence of a separate control group is central to the interpretation. The record describes a larger randomized trial as a subsequent step to compare psychological treatment options, but it does not report results from that future study.
The safety summary records zero serious adverse events, zero other adverse events, and zero deaths among 32 participants at risk. These counts describe the registry’s recorded events and do not establish the absence of all possible harms or define the completeness of safety monitoring.
Thus, the available record is useful for understanding the feasibility-study design and the planned outcome measure, but it is not enough to quantify treatment-associated change, compare treatment options, or make a precise assessment of benefit or risk.
13. Why This Trial Matters Statistically
Feasibility studies address practical questions that can matter before a larger trial is undertaken. In this case, the registry describes an audio-file delivery strategy and frames the study as a precursor to a larger randomized trial comparing psychological treatment options. An intervention delivered through a website and audio files may raise practical questions about access, use, and follow-up, but the registry does not report specific feasibility results or criteria for judging those questions.
Statistically, the single-group design is useful to distinguish from a randomized comparison. Measuring Peds-QL-gastro before and after treatment can describe scores over time, but a within-group pattern cannot by itself separate treatment effects from other explanations. A future randomized comparison, as described in the registry summary, would address a different question by comparing treatment options under a study design with a comparator.
The primary measure is continuous and has a defined range and direction: scores run from 0 to 100, with higher scores indicating a better outcome. Reporting means alongside standard deviations can describe central scores and participant variation. Reporting an estimate with an uncertainty interval would add information about precision. Those outcome statistics are not reported in the registry record, which limits what can be learned about the observed pattern.
The record also highlights the distinction between a planning calculation and an observed result. A hypothetical two-arm sample-size illustration based on an effect and specified assumptions does not show that an effect was established in this single-group feasibility study. Planning assumptions and outcome evidence answer different questions.
These design and reporting details matter because they determine what conclusions the record can support. The available information documents the study structure and measures, while leaving the primary outcome findings and feasibility results unreported.
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 main trial-specific limitation for interpretation is the single-group design. No separate comparator or randomized treatment allocation is described, so the design cannot provide a direct treatment-versus-control estimate. Any before-and-after pattern, if reported, would need to be interpreted as change over time rather than as a controlled causal comparison.
The registry does not report numerical results for the primary Peds-QL-gastro measure, despite identifying its schedule and summary measure. The means, standard deviations, estimates of change, and precision measures are absent. It also lists no analyses. This prevents assessment of the size and uncertainty of the primary outcome and makes it impossible to evaluate the reported analysis approach.
The registry record gives limited detail about the intervention and participant group. It describes website content and 5 age-adjusted audio files, but the listening schedule, treatment duration, adherence, and support during treatment are not reported. Eligibility criteria, age limits, and diagnostic details are also not reported in the registry record.
Feasibility is central to the study’s stated purpose, yet the record does not report feasibility criteria, results, or progression rules. It also does not describe how missing questionnaire data were handled, what analysis population was intended, or whether multiplicity was addressed across the listed secondary outcomes.
Finally, safety counts are reported without details of event definitions, monitoring procedures, or follow-up duration. These gaps do not change the recorded counts, but they limit interpretation of how completely adverse events were captured.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Hypnotherapy With Audiofiles for Children and Adolescents With Disorders of Gut-brain Interactions in Sweden -a Feasibility Study — NCT06493097.
- Registry record last updated 2026-01-30; status last verified 2025-12.
- Results first posted 2026-01-30.
- 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
Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
18. Record Summary
This completed feasibility study evaluates gut-directed hypnotherapy delivered through audio files for children and adolescents with disorders of gut-brain interaction in Sweden. The registry lists an enrollment of 32, a single-group design, no masking, and Karolinska Institutet as sponsor. The study start is recorded as 2023-10-01, with primary completion on 2024-06-30.
Participants receive website access with information about the diagnosis and symptom mechanisms, plus a self-hypnosis protocol using 5 age-adjusted audio files. The primary measure is Peds-QL-gastro, scheduled at Week 0 before treatment and Week 12 after treatment; higher scores on its 0-to-100 scale indicate a better outcome.
The registry record does not report numerical primary-outcome results, analysis details, or feasibility findings. Its safety summary records zero serious adverse events, zero other adverse events, and zero deaths among 32 participants at risk. The study is described as a feasibility step before a larger randomized trial.