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Trial record 61 of 238 for:    essential oil

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

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ClinicalTrials.gov Identifier: NCT03097484
Recruitment Status : Completed
First Posted : March 31, 2017
Results First Posted : May 14, 2019
Last Update Posted : May 14, 2019
Sponsor:
Information provided by (Responsible Party):
John M. Daniel, University of Kentucky

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Neonatal Abstinence Syndrome
Aromatherapy
Intervention Drug: lavender and chamomile essential oils
Enrollment 38
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Standard Therapy ALONE Standard Therapy Plus Aromatherapy
Hide Arm/Group Description These infants receive standard care ONLY, which includes morphine replacement therapy, infant massage, PT, OT, and music therapy.

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.

Period Title: Overall Study
Started 19 19
Completed 19 19
Not Completed 0 0
Arm/Group Title Standard Therapy ALONE Standard Therapy Plus Aromatherapy Total
Hide Arm/Group Description These infants receive standard care ONLY, which includes morphine replacement therapy, infant massage, PT, OT, and music therapy.

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.

Total of all reporting groups
Overall Number of Baseline Participants 19 19 38
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Days
Number Analyzed 19 participants 19 participants 38 participants
38.14  (9) 38.86  (5) 38.50  (7.28)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 19 participants 38 participants
Female
10
  52.6%
11
  57.9%
21
  55.3%
Male
9
  47.4%
8
  42.1%
17
  44.7%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 19 participants 19 participants 38 participants
19 19 38
Birth Weight  
Mean (Standard Deviation)
Unit of measure:  Kilograms
Number Analyzed 19 participants 19 participants 38 participants
2.9  (0.5) 3.1  (0.4) 3.0  (.45)
Opioid Exposure Only  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 19 participants 38 participants
8
  42.1%
9
  47.4%
17
  44.7%
Multi-Drug Exposure  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 19 participants 38 participants
11
  57.9%
10
  52.6%
21
  55.3%
1.Primary Outcome
Title Length of Hospitalization
Hide Description How long the infant remains hospitalized.
Time Frame Up to 4 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Therapy ALONE Standard Therapy Plus Aromatherapy
Hide Arm/Group Description:
These infants receive standard care ONLY, which includes morphine replacement therapy, infant massage, PT, OT, and music therapy.

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.

Overall Number of Participants Analyzed 19 19
Mean (Standard Deviation)
Unit of Measure: days
17.8  (10.1) 11.4  (6.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Standard Therapy ALONE, Standard Therapy Plus Aromatherapy
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.03
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
2.Secondary Outcome
Title Length of Medication Therapy
Hide Description How long the infant requires medication to treat symptoms.
Time Frame Up to 4 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Therapy ALONE Standard Therapy Plus Aromatherapy
Hide Arm/Group Description:
These infants receive standard care ONLY, which includes morphine replacement therapy, infant massage, PT, OT, and music therapy.

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.

Overall Number of Participants Analyzed 19 19
Mean (Standard Deviation)
Unit of Measure: days
12.7  (10.1) 7.4  (6.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Standard Therapy ALONE, Standard Therapy Plus Aromatherapy
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments 0.05 is the calculated p-value (not the threshold for statistical significance)
Method t-test, 2 sided
Comments [Not Specified]
Time Frame Until release from the hospital (up to 50 days post-birth)
Adverse Event Reporting Description Data were collected from hospital electronic medical records.
 
Arm/Group Title Standard Therapy ALONE Standard Therapy Plus Aromatherapy
Hide Arm/Group Description These infants receive standard care ONLY, which includes morphine replacement therapy, infant massage, PT, OT, and music therapy.

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.

All-Cause Mortality
Standard Therapy ALONE Standard Therapy Plus Aromatherapy
Affected / at Risk (%) Affected / at Risk (%)
Total   0/19 (0.00%)   0/19 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Standard Therapy ALONE Standard Therapy Plus Aromatherapy
Affected / at Risk (%) Affected / at Risk (%)
Total   0/19 (0.00%)   0/19 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Standard Therapy ALONE Standard Therapy Plus Aromatherapy
Affected / at Risk (%) Affected / at Risk (%)
Total   0/19 (0.00%)   0/19 (0.00%) 
Interpretation is limited by being a single-center, open-label trial.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: John Bauer, MD
Organization: University of Kentucky
Phone: 859-218-2927
EMail: john.bauer@uky.edu
Publications of Results:
Layout table for additonal information
Responsible Party: John M. Daniel, University of Kentucky
ClinicalTrials.gov Identifier: NCT03097484     History of Changes
Other Study ID Numbers: 15-0159-F2L
First Submitted: March 15, 2017
First Posted: March 31, 2017
Results First Submitted: April 1, 2019
Results First Posted: May 14, 2019
Last Update Posted: May 14, 2019