Back to resultsAromatherapy With Lavender Essential Oil in Patients With Multiple Sclerosis
Primary Purpose
Aromatherapy, Randomized Controlled Trial, Multiple Sclerosis
Status
Active
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
lavender oil
Sponsored by
About this trial
This is an interventional supportive care trial for Aromatherapy
Eligibility Criteria
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
Sites / Locations
- Ataturk Unıversity
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Experimental
Control
Arm Description
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.
No intervention will be applied to the control group.
Outcomes
Primary Outcome Measures
Fatigue Severity Scale -FSS
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.
Pittsburgh Sleep Quality Index (PUKI)
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05929638
Brief Title
Aromatherapy With Lavender Essential Oil in Patients With Multiple Sclerosis
Official Title
The Effect of Aromatherapy With Lavender Essential Oil on the Sleep and Fatigue Level of Patients With Multiple Sclerosis: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 15, 2023 (Actual)
Primary Completion Date
May 15, 2023 (Actual)
Study Completion Date
July 15, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ataturk University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aromatherapy, Randomized Controlled Trial, Multiple Sclerosis
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
No intervention will be applied to the control group.
Intervention Type
Behavioral
Intervention Name(s)
lavender oil
Intervention Description
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.
Primary Outcome Measure Information:
Title
Fatigue Severity Scale -FSS
Description
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.
Time Frame
two week
Title
Pittsburgh Sleep Quality Index (PUKI)
Description
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.
Time Frame
Two week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nihan Türkoğlu, Assist.Prof.
Organizational Affiliation
Ataturk University
Official's Role
Study Chair
Facility Information:
Facility Name
Ataturk Unıversity
City
Erzurum
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Aromatherapy With Lavender Essential Oil in Patients With Multiple Sclerosis
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