Lavender Aromatherapy for Sleep in Hospitalized Adult Patients

Northwell Health

Status: Terminated

Conditions: Hospitalization; Sleep

Treatments: Other: Grapeseed Oil; Other: lavender oil

Study type: Interventional

Funder types: Other

Identifiers

NCT04648215

20-0423

Details and patient eligibility

About

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

Full 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 .

Enrollment: 108 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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108 participants in 3 patient groups, including a placebo group

lavender oil

Experimental group

Description:

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

Treatment:

Other: lavender oil

grapeseed oil

Placebo Comparator group

Description:

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

Treatment:

Other: Grapeseed Oil

Standard of Care

No Intervention group

Description:

Routine nursing care at bedtime (HS)