Lavender Aromatherapy for Sleep in Hospitalized Adult Patients

The Effect of Lavender Aromatherapy on Sleep in Hospitalized Adult Patients

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

Study Overview

• Status: Terminated
• Conditions: Sleep; Hospitalization
• Intervention / Treatment: Other: lavender oil; Other: Grapeseed Oil

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 Type: Interventional
• Enrollment (Actual): 108
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Bay Shore, New York, United States, 11706
      • Northwell Health , South Shore University Hospital
    • Bay Shore, New York, United States, 11706
      • South Shore University Hosp

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Northwell Health

Publications and helpful links

General Publications

• Tamrat R, Huynh-Le MP, Goyal M. Non-pharmacologic interventions to improve the sleep of hospitalized patients: a systematic review. J Gen Intern Med. 2014 May;29(5):788-95. doi: 10.1007/s11606-013-2640-9. Epub 2013 Oct 10.
• Stepanski EJ, Wyatt JK. Use of sleep hygiene in the treatment of insomnia. Sleep Med Rev. 2003 Jun;7(3):215-25. doi: 10.1053/smrv.2001.0246.
• Tranmer JE, Minard J, Fox LA, Rebelo L. The sleep experience of medical and surgical patients. Clin Nurs Res. 2003 May;12(2):159-73. doi: 10.1177/1054773803012002004.
• 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.
• 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.
• Park MJ, Yoo JH, Cho BW, Kim KT, Jeong WC, Ha M. Noise in hospital rooms and sleep disturbance in hospitalized medical patients. Environ Health Toxicol. 2014 Aug 18;29:e2014006. doi: 10.5620/eht.2014.29.e2014006. eCollection 2014.

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2021
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: November 3, 2020
• First Submitted That Met QC Criteria: November 23, 2020
• First Posted (Actual): December 1, 2020

Study Record Updates

• Last Update Posted (Estimate): May 8, 2023
• Last Update Submitted That Met QC Criteria: May 4, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: lavender aromatherapy, sleep
• Other Study ID Numbers: 20-0423

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No