Trial · NCT03097484
The Effect of Aromatherapy on Neonatal Abstinence Syndrome and Salivary Cortisol Levels
NCT03097484, Phase 3, Completed, John M. Daniel; results first posted 2019-05-14
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. The Effect of Aromatherapy on Neonatal Abstinence Syndrome and Salivary Cortisol Levels. Trials, record NCT03097484. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03097484
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The Effect of Aromatherapy on Neonatal Abstinence Syndrome and Salivary Cortisol Levels
- NCT number
- NCT03097484
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 38 participants, actual
- Lead sponsor
- John M. Daniel
- Conditions
- Neonatal Abstinence Syndrome, Aromatherapy
- Interventions
- lavender and chamomile essential oils
- First posted
- 2017-03-31
- Last updated
- 2019-05-14
- Results first posted
- 2019-05-14
- Limitations and caveats
- Interpretation is limited by being a single-center, open-label trial.
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Length of Hospitalization | Up to 4 months | How long the infant remains hospitalized. |
| Secondary | Length of Medication Therapy | Up to 4 months | How long the infant requires medication to treat symptoms. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Length of Hospitalization | Up to 4 months | days | MEAN | |
| SECONDARY | Length of Medication Therapy | Up to 4 months | days | MEAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Length of Hospitalization | Standard Therapy ALONE | 17.8 | Standard Deviation 10.1 | days | |
| Length of Hospitalization | Standard Therapy Plus Aromatherapy | 11.4 | Standard Deviation 6.6 | days | |
| Length of Medication Therapy | Standard Therapy ALONE | 12.7 | Standard Deviation 10.1 | days | |
| Length of Medication Therapy | Standard Therapy Plus Aromatherapy | 7.4 | Standard Deviation 6.1 | days |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Standard Therapy ALONE | 19 | |
| Overall Study | STARTED | Standard Therapy Plus Aromatherapy | 19 | |
| Overall Study | COMPLETED | Standard Therapy ALONE | 19 | |
| Overall Study | COMPLETED | Standard Therapy Plus Aromatherapy | 19 | |
| Overall Study | NOT COMPLETED | Standard Therapy ALONE | 0 | |
| Overall Study | NOT COMPLETED | Standard Therapy Plus Aromatherapy | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Standard Therapy ALONE | 0 | 19 |
| Total, all-cause mortality | Standard Therapy Plus Aromatherapy | 0 | 19 |
| Total, other adverse events | Standard Therapy ALONE | 0 | 19 |
| Total, other adverse events | Standard Therapy Plus Aromatherapy | 0 | 19 |
| Total, serious adverse events | Standard Therapy ALONE | 0 | 19 |
| Total, serious adverse events | Standard Therapy Plus Aromatherapy | 0 | 19 |
Source ClinicalTrials.gov
Papers17
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Standard Therapy ALONE vs Standard Therapy Plus Aromatherapy: deaths from any cause | Trial comparisons |
| Standard Therapy ALONE vs Standard Therapy Plus Aromatherapy: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03097484
GET https://conductscience.org/api/trials/v1/NCT03097484/registered