NCT04648215

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2021

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 3, 2020

Completed
28 days until next milestone

First Posted

Study publicly available on registry

December 1, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

February 22, 2021

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

May 6, 2023

Status Verified

May 1, 2023

Enrollment Period

1.9 years

First QC Date

November 3, 2020

Last Update Submit

May 4, 2023

Conditions

SleepHospitalization

Keywords

lavender aromatherapy, sleep

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (3)

lavender oil

EXPERIMENTAL

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

Other: lavender oil

grapeseed oil

PLACEBO COMPARATOR

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

Other: Grapeseed Oil

Standard of Care

NO INTERVENTION

Routine nursing care at bedtime (HS)

Interventions

lavender oilOTHER

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

lavender oil
Grapeseed OilOTHER

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

grapeseed oil

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ability to speak, read and understand English.
  • Ability to use an electronic "pad" following instruction and assistance for data collection

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Northwell Health , South Shore University Hospital

Bay Shore, New York, 11706, United States

Location

South Shore University Hosp

Bay Shore, New York, 11706, United States

Location

Related Publications (6)

  • 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.

    PMID: 12927121BACKGROUND

  • 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.

    PMID: 24113807BACKGROUND

  • 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.

    PMID: 12741668BACKGROUND

  • 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.

    PMID: 29375641RESULT

  • 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.

    PMID: 27280292RESULT

  • 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.

    PMID: 25163680RESULT

MeSH Terms

Interventions

lavender oil

Study Officials

  • Jane H. White, PhD

    Northwell Health, Nurse Scientist IFN

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Randomized three group design : lavender aromatherapy (intervention); grapeseed oil aromatherapy (placebo) ; standard of care for night time (control)
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 2020

First Posted

December 1, 2020

Study Start

February 22, 2021

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

May 6, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

US(2)