The Effect of Aromatherapy on Neonatal Abstinence Syndrome and Salivary Cortisol Levels
NCT ID: NCT03097484
Last Updated: 2019-05-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
38 participants
INTERVENTIONAL
2015-07-25
2017-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Standard therapy ALONE
These infants receive standard care ONLY, which includes morphine replacement therapy, infant massage, PT, OT, and music therapy.
No interventions assigned to this group
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Intrauterine opioid exposure
* Primary diagnosis of NAS
* Parental permission to participate
Exclusion Criteria
* 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
2 Weeks
ALL
No
Sponsors
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John M. Daniel
OTHER
Responsible Party
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John M. Daniel
Fellow, Department of Pediatrics, Division of Neonatology
Principal Investigators
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John M Daniel, MD
Role: PRINCIPAL_INVESTIGATOR
University of Kentucky
Locations
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University of Kentucky
Lexington, Kentucky, United States
Countries
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References
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Ang JY, Lua JL, Mathur A, Thomas R, Asmar BI, Savasan S, Buck S, Long M, Shankaran S. A randomized placebo-controlled trial of massage therapy on the immune system of preterm infants. Pediatrics. 2012 Dec;130(6):e1549-58. doi: 10.1542/peds.2012-0196. Epub 2012 Nov 12.
Candia MF, Osaku EF, Leite MA, Toccolini B, Costa NL, Teixeira SN, Costa CR, Piana PA, Cristovam MA, Osaku NO. Influence of prone positioning on premature newborn infant stress assessed by means of salivary cortisol measurement: pilot study. Rev Bras Ter Intensiva. 2014 Apr-Jun;26(2):169-75. doi: 10.5935/0103-507x.20140025.
Conde-Agudelo A, Diaz-Rossello JL. Kangaroo mother care to reduce morbidity and mortality in low birthweight infants. Cochrane Database Syst Rev. 2014 Apr 22;(4):CD002771. doi: 10.1002/14651858.CD002771.pub3.
Field T, Diego M, Hernandez-Reif M, Cisneros W, Feijo L, Vera Y, Gil K, Grina D, Claire He Q. Lavender fragrance cleansing gel effects on relaxation. Int J Neurosci. 2005 Feb;115(2):207-22. doi: 10.1080/00207450590519175.
Field T, Field T, Cullen C, Largie S, Diego M, Schanberg S, Kuhn C. Lavender bath oil reduces stress and crying and enhances sleep in very young infants. Early Hum Dev. 2008 Jun;84(6):399-401. doi: 10.1016/j.earlhumdev.2007.10.008. Epub 2007 Nov 28.
Filippelli AC, White LF, Spellman LW, Broderick M, Highfield ES, Sommers E, Gardiner P. Non-Insertive Acupuncture and Neonatal Abstinence Syndrome: A Case Series from an Inner City Safety Net Hospital. Glob Adv Health Med. 2012 Sep;1(4):48-52. doi: 10.7453/gahmj.2012.1.4.007.
Hayes MJ, Brown MS. Epidemic of prescription opiate abuse and neonatal abstinence. JAMA. 2012 May 9;307(18):1974-5. doi: 10.1001/jama.2012.4526. Epub 2012 Apr 30. No abstract available.
Loewy J, Stewart K, Dassler AM, Telsey A, Homel P. The effects of music therapy on vital signs, feeding, and sleep in premature infants. Pediatrics. 2013 May;131(5):902-18. doi: 10.1542/peds.2012-1367. Epub 2013 Apr 15.
Maeda A, Bateman BT, Clancy CR, Creanga AA, Leffert LR. Opioid abuse and dependence during pregnancy: temporal trends and obstetrical outcomes. Anesthesiology. 2014 Dec;121(6):1158-65. doi: 10.1097/ALN.0000000000000472.
Namazi M, Amir Ali Akbari S, Mojab F, Talebi A, Alavi Majd H, Jannesari S. Aromatherapy with citrus aurantium oil and anxiety during the first stage of labor. Iran Red Crescent Med J. 2014 Jun;16(6):e18371. doi: 10.5812/ircmj.18371. Epub 2014 Jun 5.
Olson SL. Bedside musical care: applications in pregnancy, childbirth, and neonatal care. J Obstet Gynecol Neonatal Nurs. 1998 Sep-Oct;27(5):569-75. doi: 10.1111/j.1552-6909.1998.tb02624.x.
Parlier AB, Fagan B, Ramage M, Galvin S. Prenatal care, pregnancy outcomes, and postpartum birth control plans among pregnant women with opiate addictions. South Med J. 2014 Nov;107(11):676-83. doi: 10.14423/SMJ.0000000000000189.
Patrick SW, Schumacher RE, Benneyworth BD, Krans EE, McAllister JM, Davis MM. Neonatal abstinence syndrome and associated health care expenditures: United States, 2000-2009. JAMA. 2012 May 9;307(18):1934-40. doi: 10.1001/jama.2012.3951. Epub 2012 Apr 30.
Tang SK, Tse MY. Aromatherapy: does it help to relieve pain, depression, anxiety, and stress in community-dwelling older persons? Biomed Res Int. 2014;2014:430195. doi: 10.1155/2014/430195. Epub 2014 Jul 13.
Thomas DV. Aromatherapy: mythical, magical, or medicinal? Holist Nurs Pract. 2002 Oct;16(5):8-16. doi: 10.1097/00004650-200210000-00005.
Tryphonopoulos PD, Letourneau N, Azar R. Approaches to salivary cortisol collection and analysis in infants. Biol Res Nurs. 2014 Oct;16(4):398-408. doi: 10.1177/1099800413507128. Epub 2013 Oct 16.
Pahl A, Young L, Buus-Frank ME, Marcellus L, Soll R. Non-pharmacological care for opioid withdrawal in newborns. Cochrane Database Syst Rev. 2020 Dec 21;12(12):CD013217. doi: 10.1002/14651858.CD013217.pub2.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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15-0159-F2L
Identifier Type: -
Identifier Source: org_study_id
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