Lavender Aromatherapy for Sleep in Hospitalized Adult Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-22

Study Completion Date

2022-12-31

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

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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 .

Conditions

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Sleep Hospitalization

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized three group design : lavender aromatherapy (intervention); grapeseed oil aromatherapy (placebo) ; standard of care for night time (control)

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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lavender oil

lavender oil as aromatherapy two drops dispensed on a 2x2 gauze and pinned to subject's gown

Group Type EXPERIMENTAL

lavender oil

Intervention Type OTHER

aromatherapy--two drops applied to a 2x2 gauze and pinned to subject's gown

grapeseed oil

grapeseed oil as aromatherapy two drops dispensed on a 2x2 gauze and pinned to subject's gown

Group Type PLACEBO_COMPARATOR

Grapeseed Oil

Intervention Type OTHER

aromatherapy--two drops applied to a 2 X 2 gauze and pinned to subject's gown

Standard of Care

Routine nursing care at bedtime (HS)

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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lavender oil

aromatherapy--two drops applied to a 2x2 gauze and pinned to subject's gown

Intervention Type OTHER

Grapeseed Oil

aromatherapy--two drops applied to a 2 X 2 gauze and pinned to subject's gown

Intervention Type OTHER

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No