- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05929638
Aromatherapy With Lavender Essential Oil in Patients With Multiple Sclerosis
June 29, 2023 updated by: Esin Kavuran, Ataturk University
The Effect of Aromatherapy With Lavender Essential Oil on the Sleep and Fatigue Level of Patients With Multiple Sclerosis: A Randomized Controlled Trial
The study was conducted with patients with Multiple Sclerosis (MS) who applied to the Neurology Outpatient Clinic of Atatürk University Research Hospital, met the inclusion criteria and agreed to participate in the study.
At the time of the study, 96 patients were interviewed.
26 patients were excluded from the study because they did not meet the research criteria, and 70 multiple sclerosis patients constituted the research sample. 1 person from the control group and 1 person from the experimental group did not continue to work and 1 person developed a lavender allergy.
The study was completed with 63 multiple sclerosis patients.
Study Overview
Status
Active, not recruiting
Intervention / Treatment
Detailed Description
Patient Description, Fatigue Severity Scale and Pittsburgh Sleep Quality Index were applied to the patients at the first interview.
Lavender oil in 15 ml opaque dark colored bottles closed with metal caps to prevent volatility to the venture group (Oleum Lavandula Angustifolia/ HACCP, Halal Food, ISO 22000:2005, ISO 14001:2015, ISO 9001:2015, ISO 45001:2018) certificates) and 40 2×2 cotton pads were delivered.
Studies have reported that the most common use of aromatherapy is three drops, three days a week.
Patients were asked to apply lavender oil 30 minutes before going to bed.
Deep breathing increases the concentration of aromatic substances in the body.
The time it takes for essential oils to be absorbed into the blood circulatory system is about 30 minutes for complete absorption by the body.
Study Type
Interventional
Enrollment (Estimated)
70
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Erzurum, Turkey
- Ataturk Unıversity
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Being 18 years or older,
- Having been diagnosed with MS at least 1 year ago,
- Verbal communication (hearing and speaking)
- No problem with sense of smell,
- Not having an allergy to lavender,
- Having fatigue and sleep problems for the last 3 months,
- Not applying an intervention that helps to fall asleep,
- Pittsburgh Sleep Quality Index ≥5,
- Fatigue Severity Scale ≥4.
Exclusion Criteria:
- Having had an attack in the last month,
- Having DSM-IV Axis I disorder,
- Pregnancy,
- Using sleeping pills,
- Breastfeeding
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
No intervention will be applied to the control group.
|
|
Experimental: Experimental
Lavender oil in 15 ml opaque dark colored bottles closed with metal caps to prevent volatility to the venture group and 40 2×2 cotton pads were delivered.
Patients were asked to apply lavender oil 30 minutes before going to bed.
Deep breathing increases the concentration of aromatic substances in the body.
The time it takes for essential oils to be absorbed into the blood circulatory system is about 30 minutes for complete absorption by the body.
Information was given about dripping 3 drops of lavender oil on cotton pads and placing them 15-20 cm away from the pillow.
Patients were told that they should apply lavender oil for 30 days and re-prepare the lavender oil dripped onto a new pad each night, and that the bedroom should be ventilated and free of different odors.
A message was sent to the patients to remind them of the application on their phones for 30 days.
|
The patients participating in the study were provided with the steps of applying lavender oil by inhalation, the points to be considered during the application, and the application was done in the same way by all patients.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fatigue Severity Scale -FSS
Time Frame: two week
|
The Turkish validity and reliability of the Fatigue Severity Scale, developed by Krupp et al. (1989), was determined by Armutlu et al. made by The scale is a 7-point Likert-type scale consisting of nine items.
Each item is defined as 1 = strongly disagree, 7 = completely agree.
The score that can be obtained from the scale varies between 9-63, and when divided by the number of items, the lowest score that can be obtained from the scale is 1 and the highest score is 7.
|
two week
|
Pittsburgh Sleep Quality Index (PUKI)
Time Frame: Two week
|
In 1989 Buysse et al.
It was developed by Psychiatry to evaluate sleep quality in clinical studies and psychiatry practices.
PSQI, which consists of 7 main headings: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disorders, use of sleeping pills and daytime functions, evaluates sleep quality in the last month.
Each subheading is evaluated between 0-3 points.
|
Two week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Nihan Türkoğlu, Assist.Prof., Ataturk University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 15, 2023
Primary Completion (Actual)
May 15, 2023
Study Completion (Estimated)
July 15, 2023
Study Registration Dates
First Submitted
May 23, 2023
First Submitted That Met QC Criteria
June 29, 2023
First Posted (Actual)
July 3, 2023
Study Record Updates
Last Update Posted (Actual)
July 3, 2023
Last Update Submitted That Met QC Criteria
June 29, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Esin23
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Multiple Sclerosis
-
University Hospital, Basel, SwitzerlandSwiss National Science FoundationRecruitingMultiple Sclerosis (MS) | Relapsing-remitting Multiple Sclerosis (RRMS) | Secondary-progressive Multiple Sclerosis (SPMS) | Primary Progressive Multiple Sclerosis (PPMS)Switzerland
-
University of California, Los AngelesUnknownRelapsing-remitting Multiple Sclerosis | Secondary-progressive Multiple Sclerosis | Primary-progressive Multiple SclerosisUnited States
-
BiogenCompletedMultiple Sclerosis | Relapsing-Remitting Multiple Sclerosis | Secondary Progressive Multiple Sclerosis | Multiple Sclerosis, Primary Progressive | Multiple Sclerosis, Remittent ProgressiveJapan
-
The Cleveland ClinicUniversity Hospitals Cleveland Medical CenterCompletedRelapsing-Remitting Multiple Sclerosis | Secondary Progressive Multiple Sclerosis | Progressive Relapsing Multiple SclerosisUnited States
-
Rigshospitalet, DenmarkOdense University Hospital; Aarhus University Hospital; Hvidovre University Hospital and other collaboratorsRecruitingRelapsing Remitting Multiple Sclerosis | Primary Progressive Multiple Sclerosis | Secondary Progressive Multiple SclerosisDenmark
-
University of California, San FranciscoUnited States Department of DefenseRecruitingMultiple Sclerosis, Chronic Progressive | Multiple Sclerosis, Relapsing-Remitting | Multiple Sclerosis (MS) | Multiple Sclerosis Relapse | Multiple Sclerosis, Primary Progressive | Multiple Sclerosis Brain Lesion | Multiple Sclerosis BenignUnited States
-
Icahn School of Medicine at Mount SinaiColumbia University; New York Stem Cell Foundation Research InstituteCompletedClinically Isolated Syndrome | Relapsing-Remitting Multiple Sclerosis | Primary Progressive Multiple Sclerosis | Secondary Progressive Multiple SclerosisUnited States
-
Queen Mary University of LondonTakeda Pharmaceuticals International, Inc.RecruitingRelapsing Remitting Multiple Sclerosis | Primary Progressive Multiple Sclerosis | Secondary Progressive Multiple SclerosisUnited Kingdom
-
Banc de Sang i TeixitsVall d'Hebron Research Institute (VHIR)CompletedRelapsing-Remitting Multiple Sclerosis | Secondary Progressive Multiple SclerosisSpain
-
BiogenElan PharmaceuticalsCompletedRelapsing-Remitting Multiple Sclerosis | Secondary Progressive Multiple SclerosisUnited States
Clinical Trials on lavender oil
-
Wake Forest University Health SciencesCompletedAnxiety | Anxiety Preoperative
-
TC Erciyes UniversityTÜBİTAKRecruiting
-
TC Erciyes UniversityCompletedCholecystectomy | AromatherapyTurkey
-
Near East University, TurkeyCompleted
-
Mike O'Callaghan Military HospitalAmerican Academy of Family PhysiciansCompletedColposcopyUnited States
-
Northwell HealthTerminatedSleep | HospitalizationUnited States
-
Huan DingUnknownMild Cognitive ImpairmentChina
-
MetroHealth Medical CenterCompletedPain | Low Back Pain | Procedural Pain | Procedural AnxietyUnited States
-
Soroka University Medical CenterUnknown
-
Cairo UniversityCompleted