Lavender Aromatherapy for Sleep in Hospitalized Adult Patients

Sleep Clinical Trial

Official title:

The Effect of Lavender Aromatherapy on Sleep in Hospitalized Adult Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04648215
• Other study ID #: 20-0423
• Status: Terminated
• Phase: N/A
• Start date: February 22, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: May 2023
• Source: Northwell Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 .

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 108
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hospitalization
• Sleep

Intervention

Other:
• lavender oil
aromatherapy--two drops applied to a 2x2 gauze and pinned to subject's gown
• Grapeseed Oil
aromatherapy--two drops applied to a 2 X 2 gauze and pinned to subject's gown

Locations

Country	Name	City	State
United States	Northwell Health , South Shore University Hospital	Bay Shore	New York
United States	South Shore University Hosp	Bay Shore	New York

Sponsors (1)

Lead Sponsor	Collaborator
Northwell Health

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View Citation

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. eCo — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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