Lavender Aromatherapy for Sleep in Hospitalized Adult Patients

Study Overview
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Brief Summary
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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
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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 .

Official Title
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The Effect of Lavender Aromatherapy on Sleep in Hospitalized Adult Patients

Conditions
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Sleep, Hospitalization

Intervention / Treatment
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* Other: lavender oil
* Other: Grapeseed Oil


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized three group design : lavender aromatherapy (intervention); grapeseed oil aromatherapy (placebo) ; standard of care for night time (control)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: lavender oil<br>lavender oil as aromatherapy two drops dispensed on a 2x2 gauze and pinned to subject's gown | Other: lavender oil<br>* aromatherapy--two drops applied to a 2x2 gauze and pinned to subject's gown<br>|
| Placebo Comparator: grapeseed oil<br>grapeseed oil as aromatherapy two drops dispensed on a 2x2 gauze and pinned to subject's gown | Other: Grapeseed Oil<br>* aromatherapy--two drops applied to a 2 X 2 gauze and pinned to subject's gown<br>|
| No Intervention: Standard of Care<br>Routine nursing care at bedtime (HS) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in sleep duration from Baseline to Day 3 and day 4 | Measured by an increase in the mean scores Verans and Snyder-Halpern Sleep Scale (0-100) by 10 or greater | Baseline, Day 3, Day 4 | 
| Change in sleep quality from Baseline to Day 3 and Day 4 | Measured by an increase in mean scores on the the Verans and Snyder-Halpern Sleep Scale of 10 or greater | Baseline Day 3, Day 4 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lavender aromatherapy, sleep