Clinical trial NCT04648215: Lavender Aromatherapy for Sleep in Hospitalized Adult Patients
Official title: The Effect of Lavender Aromatherapy on Sleep in Hospitalized Adult Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Sleep
Hospitalization
Keywords: lavender aromatherapy, sleep
Lead sponsor: Northwell Health
Sponsor class: OTHER
First posted: 2020-12-01
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized three group design : lavender aromatherapy (intervention); grapeseed oil aromatherapy (placebo) ; standard of care for night time (control)
Primary purpose: SUPPORTIVE_CARE

Brief summary: This feasibility study's aim is to determine the effectiveness of lavender oil aromatherapy on quality and duration of sleep in hospitalized adult patients

Detailed description: Hospitalized patients on a medical unit will be randomly assigned to one of three groups of 36 patients: Intervention (Lavender oil), Placebo Intervention (Grapeseed Oil), or Control (Standard of Care). Following a determination of meeting inclusion criteria on admission and completing informed consent, subjects will be randomized to one of three groups on admission. This is a 4 day study with pre- intervention (baseline) sleep data on quality and duration of sleep using the Verrans \& Halpern- Snyder Sleep Scale collected on Day 2, following admission day.

For the intervention, indirect aromatherapy, a 2x2 gauze with 2 drops of either oil (lavender or grapeseed is pinned it to the subjects' nightgown (right scapula area) for two sequential nights (Time 1 and Time 2) (Day 2 and 3) and removed in the morning after 10 hours . Sleep Quality and Duration are then measured in the morning, Time 1 and Time 2, (Day 3 and Day 4) by the Verran \& Snyder-Halpern Sleep Scale analogue. The control group receives standard of care in the evenings and the same data as the intervention groups are collected for sleep quality and duration, pre-intervention and Time 1 and Time 2 ..

The differences in the scores for sleep quality and duration will be compared from pre-intervention to Time 1 and Time 2 for each group .

Eligibility criteria: Inclusion Criteria

* Ability to speak, read and understand English.
* Ability to use an electronic "pad" following instruction and assistance for data collection

Exclusion Criteria:

* Cognitive impairment .Allergy to lavender or grapeseed oil
* .Any condition that has been reported to affect the sense of smell
* Newly prescribed sleep medications (last two weeks prior to admission) or those causing sleepiness
* Pregnancy
* Currently using lavender therapy (aroma, massage, etc.).
* A smoker of any kind (tobacco, electronic cigarettes) .
* History of migraine headaches.
* Asthma, Bronchitis, or any airway disease.

Primary outcomes:
measure: Change in sleep duration from Baseline to Day 3 and day 4
timeFrame: Baseline, Day 3, Day 4
measure: Change in sleep quality from Baseline to Day 3 and Day 4
timeFrame: Baseline Day 3, Day 4
Secondary outcomes:
Other outcomes:
Locations:
city: Bay Shore
country: United States
facility: Northwell Health , South Shore University Hospital
state: New York
city: Bay Shore
country: United States
facility: South Shore University Hosp
state: New York
Study officials:
affiliation: Northwell Health, Nurse Scientist IFN
name: Jane H. White, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Cho EH, Lee MY, Hur MH. The Effects of Aromatherapy on Intensive Care Unit Patients' Stress and Sleep Quality: A Nonrandomised Controlled Trial. Evid Based Complement Alternat Med. 2017;2017:2856592. doi: 10.1155/2017/2856592. Epub 2017 Dec 11.
citation: Dobing S, Frolova N, McAlister F, Ringrose J. Sleep Quality and Factors Influencing Self-Reported Sleep Duration and Quality in the General Internal Medicine Inpatient Population. PLoS One. 2016 Jun 9;11(6):e0156735. doi: 10.1371/journal.pone.0156735. eCollection 2016.
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