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The Effect of Aromatherapy on Neonatal Abstinence Syndrome and Salivary Cortisol Levels

NCT03097484 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2019-05-14

Study results available
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Summary

Determine the effectiveness of lavender and chamomile aromatherapy of mitigation of symptoms of Neonatal Abstinence Syndrome

Conditions

  • Neonatal Abstinence Syndrome
  • Aromatherapy

Interventions

DRUG

lavender and chamomile essential oils

Our patches are obtained from BioEsse Technologies™. Each patch contains a 50:50 mixture of Lavender and Chamomile essential oils in a 55 microliter standard dose patch. The patches release the aromatherapy over a 2-8 hours period and the diffusion rate of each patch is identical. The back of the patch is layered with a hypoallergenic medical grade adhesive, similar to the material found on ECG leads.

Sponsors & Collaborators

  • John M. Daniel

    lead OTHER

Principal Investigators

  • John M Daniel, MD · University of Kentucky

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
2 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-25
Primary Completion
2017-04-30
Completion
2017-04-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03097484 on ClinicalTrials.gov