The Effect of Lavender Aromatherapy on Sleep in Hospitalized Adult Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Northwell Health
- Enrollment
- 108
- Locations
- 2
- Primary Endpoint
- Change in sleep duration from Baseline to Day 3 and day 4
Study Overview
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 .
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
grapeseed oil
grapeseed oil as aromatherapy two drops dispensed on a 2x2 gauze and pinned to subject's gown
Intervention: Grapeseed Oil (Other)
Standard of Care
Routine nursing care at bedtime (HS)
lavender oil
lavender oil as aromatherapy two drops dispensed on a 2x2 gauze and pinned to subject's gown
Intervention: lavender oil (Other)
Outcomes
Primary Outcomes
Change in sleep duration from Baseline to Day 3 and day 4
Time Frame: Baseline, Day 3, Day 4
Measured by an increase in the mean scores Verans and Snyder-Halpern Sleep Scale (0-100) by 10 or greater
Change in sleep quality from Baseline to Day 3 and Day 4
Time Frame: Baseline Day 3, Day 4
Measured by an increase in mean scores on the the Verans and Snyder-Halpern Sleep Scale of 10 or greater
Secondary Outcomes
No secondary outcomes reported