SleepNCT04648215
Lavender Aromatherapy for Sleep in Hospitalized Adult Patients
A study testing lavender oil and Grapeseed Oil in people with Sleep and Hospitalization, run by Northwell Health at 2 sites in United States.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep, Hospitalization
- What is being tested?
- lavender oil and Grapeseed Oil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 2 sitesUnited States
- Study dates
- 22 Feb 2021to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability to speak, read and understand English.
- Ability to use an electronic "pad" following instruction and assistance for data collection
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
United States2 sites
Northwell Health , South Shore University Hospital
Bay Shore, New York, 11706
South Shore University Hosp
Bay Shore, New York, 11706
About this study
Official title: 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
Read the 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 .
- Conditions
- Sleep, Hospitalization
- Being tested
- lavender oil, Grapeseed Oil
- Keywords
- lavender aromatherapy, sleep
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lavender oilOther
aromatherapy--two drops applied to a 2x2 gauze and pinned to subject's gown
Grapeseed OilOther
aromatherapy--two drops applied to a 2 X 2 gauze and pinned to subject's gown
| Study group | Role | What they receive |
|---|---|---|
| lavender oil | Experimental | lavender oil as aromatherapy two drops dispensed on a 2x2 gauze and pinned to subject's gown Receives: Other: lavender oil |
| grapeseed oil | Placebo comparator | grapeseed oil as aromatherapy two drops dispensed on a 2x2 gauze and pinned to subject's gown Receives: Other: Grapeseed Oil |
| Standard of Care | No intervention | Routine nursing care at bedtime (HS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Baseline Day 3, Day 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2020
- Study start22 Feb 2021
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Why it stopped: unavailable subjects
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for SleepStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized three group design : lavender aromatherapy (intervention); grapeseed oil aromatherapy (placebo) ; standard of care for night time (control)
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jane H. White, PhD, Principal investigator, Northwell Health, Nurse Scientist IFN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04648215
- Sponsor's protocol ID
- 20-0423
- Status last verified
- May 2023
- First submitted
- 3 Nov 2020
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 12927121Tamrat 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.
PubMed 24113807Tranmer 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.
PubMed 12741668Cho 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.
PubMed 29375641Dobing 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.
PubMed 27280292Park 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.
PubMed 25163680
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Lavender Aromatherapy on Sleep in Hospitalized Adult Patients
- ClinicalTrials.gov ID
- NCT04648215
- Acronym / sponsor ID
- 20-0423
- Conditions
- Sleep, Hospitalization
- Keywords
- lavender aromatherapy, sleep
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: unavailable subjects
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Study start
- 22 Feb 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 1 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This feasibility study's aim is to determine the effectiveness of lavender oil aromatherapy on quality and duration of sleep in hospitalized adult patients
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Randomized three group design : lavender aromatherapy (intervention); grapeseed oil aromatherapy (placebo) ; standard of care for night time (control)
| Arm | Type | Receives |
|---|---|---|
| lavender oil | Experimental | Other: lavender oillavender oil as aromatherapy two drops dispensed on a 2x2 gauze and pinned to subject's gown |
| grapeseed oil | Placebo comparator | Other: Grapeseed Oilgrapeseed oil as aromatherapy two drops dispensed on a 2x2 gauze and pinned to subject's gown |
| Standard of Care | No intervention | –Routine nursing care at bedtime (HS) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Ability to speak, read and understand English.
- Ability to use an electronic "pad" following instruction and assistance for data collection
Key exclusion criteria (8 listed)
- 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.).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lavender oilaromatherapy--two drops applied to a 2x2 gauze and pinned to subject's gown | Other | lavender oil |
| Grapeseed Oilaromatherapy--two drops applied to a 2 X 2 gauze and pinned to subject's gown | Other | grapeseed oil |
Primary outcome
Change in sleep duration from Baseline to Day 3 and day 4
Time frame: Baseline, Day 3, Day 4
Measured by an increase in the mean scores Verans and Snyder-Halpern Sleep Scale (0-100) by 10 or greater
Change in sleep quality from Baseline to Day 3 and Day 4
Time frame: Baseline Day 3, Day 4
Measured by an increase in mean scores on the the Verans and Snyder-Halpern Sleep Scale of 10 or greater
Results and safety
The study was stopped early (reason given: unavailable subjects). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
- Background: PubMed 12927121Stepanski 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.
- Background: PubMed 24113807Tamrat 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.
- Background: PubMed 12741668Tranmer 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.
- Results publication: PubMed 29375641Cho 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.
- Results publication: PubMed 27280292Dobing 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.
- Results publication: PubMed 25163680Park 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.
- Individual participant dataSharing planned: No
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Healthy Adult Participants
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jane H. White, PhD principal investigator
Northwell Health, Nurse Scientist IFN
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lavender oil and Grapeseed Oil in people with Sleep and Hospitalization, run by Northwell Health at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: unavailable subjects). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in sleep duration from Baseline to Day 3 and day 4 (time frame: Baseline, Day 3, Day 4). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04648215, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2023.