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

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03097484
Enrollment
38
Registered
2017-03-31
Start date
2015-07-25
Completion date
2017-04-30
Last updated
2019-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aromatherapy, Neonatal Abstinence Syndrome

Brief summary

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

Detailed description

The United States, Appalachia, Eastern Kentucky in particular, is in the midst of a major opioid abuse epidemic. This current epidemic is driven by misuse of prescription painkillers, i.e. Subutex and Saboxone. As prescription pills become more expensive and harder to acquire, addicts are seeking similar, cheaper drugs; such as heroin. From 1998 to 2011, the prevalence of opioid abuse and dependence amongst pregnant women has increased by 127%, from 1.7 per 1000 to 3.9 per 1000. Neonatal Abstinence Syndrome (NAS) or neonatal opioid withdrawal syndrome is a condition produces gastrointestinal and autonomic neurologic dysfunction. Infants with severe withdrawal experience dysregulation of autonomic functions, resulting in feeding difficulty, diarrhea, excessive sleepiness, and tremors.Nearly two thirds of all babies exposed to opioids during gestation will require admission to a neonatal intensive care unit for management of withdrawal symptoms. During a typical year the Neonatal Intensive Care Unit (NICU) at Kentucky Children's Hospital admits approximately 100-120 infants exhibiting NAS symptoms; these infants have a typical length of stay of 24 days if they require pharmacologic treatment. The mainstay of treatment for NAS involves opioid replacement therapy with morphine to minimize withdrawal symptoms. Once symptoms are well controlled, the infant is said to have been captured. At this point a slow weaning of his morphine dose occurs. The infants' clinical status is assessed with the Finnegan Scoring system, which examines symptoms such as crying, excessive sleepiness or difficulty sleeping, insomnia, or tremors along with objective findings such as temperature and respiratory rate. In addition to pharmacotherapy, alternative and complementary medicine techniques are slowly entering the NAS treatment algorithm. Treatments such as music therapy infant massage, kangaroo care, aromatherapy, and acupressure are now employed in NICUs in addition to traditional opioids replacement. However, few studies exist in the literature to evaluate their effectiveness. Aromatherapy is the practice of using natural essential oils to achieve a desired effect in an individual. Scents such as lavender and chamomile have been documented to have a soothing calming effect. Studies involving infants shown that lavender not only reduce crying and enhance sleep, but also reduce levels of salivary cortisol, a stress hormone. Additionally, aromatherapy is currently used as an adjunctive therapy at the University of Kentucky's Markey Cancer Center. Salivary cortisol is a non-invasive biomarker that has proven useful for monitoring stress in neonates. It is a simple and painless method for monitoring the stress hormone cortisol. Salivary cortisol has been used successfully in infants as a method to assess infant stress associated with prone position versus supine positioning.These studies have shown that salivary cortisol levels vary with stressful or soothing stimuli. To date, no dangerous or deleterious effects have been described from traditional inhalational use of aromatherapy or with salivary cortisol sampling. Studies have shown aromatherapy to be an effective adjunctive therapy by proving a calming effect. In our patient population it may prove to be a useful complimentary therapy ultimately reducing infant stress, hospital length of stay, and burden of opioid use. Additionally, salivary cortisol's ease of collection and non-invasive nature make it an ideal biomarker to study.

Interventions

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

John M. Daniel
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 2 Weeks
Healthy volunteers
No

Inclusion criteria

* Infants greater than or equal to 36 weeks EGA * Intrauterine opioid exposure * Primary diagnosis of NAS * Parental permission to participate

Exclusion criteria

* Infants less than 36 weeks EGA * Major congenital anomalies * Latrogenic drug withdrawal * Diagnosis of infection or respiratory distress * Prior initiation of opioid replacement therapy * Non-English speaking * Infants with respiratory conditions

Design outcomes

Primary

MeasureTime frameDescription
Length of HospitalizationUp to 4 monthsHow long the infant remains hospitalized.

Secondary

MeasureTime frameDescription
Length of Medication TherapyUp to 4 monthsHow long the infant requires medication to treat symptoms.

Countries

United States

Participant flow

Participants by arm

ArmCount
Standard Therapy ALONE
These infants receive standard care ONLY, which includes morphine replacement therapy, infant massage, PT, OT, and music therapy.
19
Standard Therapy Plus Aromatherapy
These infants will receive aromatherapy, consisting of Lavender and Chamomile essential oils, in addition to standard care, which includes morphine replacement therapy, infant massage, PT, OT, and music therapy. 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.
19
Total38

Baseline characteristics

CharacteristicStandard Therapy Plus AromatherapyTotalStandard Therapy ALONE
Age, Continuous38.86 days
STANDARD_DEVIATION 5
38.50 days
STANDARD_DEVIATION 7.28
38.14 days
STANDARD_DEVIATION 9
Birth Weight3.1 kilograms
STANDARD_DEVIATION 0.4
3.0 kilograms
STANDARD_DEVIATION 0.45
2.9 kilograms
STANDARD_DEVIATION 0.5
Multi-Drug Exposure10 Participants21 Participants11 Participants
Opioid Exposure Only9 Participants17 Participants8 Participants
Race and Ethnicity Not Collected0 Participants
Region of Enrollment
United States
19 participants38 participants19 participants
Sex: Female, Male
Female
11 Participants21 Participants10 Participants
Sex: Female, Male
Male
8 Participants17 Participants9 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 190 / 19
other
Total, other adverse events
0 / 190 / 19
serious
Total, serious adverse events
0 / 190 / 19

Outcome results

Primary

Length of Hospitalization

How long the infant remains hospitalized.

Time frame: Up to 4 months

ArmMeasureValue (MEAN)Dispersion
Standard Therapy ALONELength of Hospitalization17.8 daysStandard Deviation 10.1
Standard Therapy Plus AromatherapyLength of Hospitalization11.4 daysStandard Deviation 6.6
p-value: 0.03t-test, 2 sided
Secondary

Length of Medication Therapy

How long the infant requires medication to treat symptoms.

Time frame: Up to 4 months

ArmMeasureValue (MEAN)Dispersion
Standard Therapy ALONELength of Medication Therapy12.7 daysStandard Deviation 10.1
Standard Therapy Plus AromatherapyLength of Medication Therapy7.4 daysStandard Deviation 6.1
p-value: 0.05t-test, 2 sided

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026