Aromatherapy With Lavender Essential Oil in Patients With Multiple Sclerosis

Multiple Sclerosis Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05929638
• Other study ID #: Esin23
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 15, 2023
• Est. completion date: July 15, 2023

Study information

• Verified date: June 2023
• Source: Ataturk University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 70
• Est. completion date: July 15, 2023
• Est. primary completion date: May 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aromatherapy
• Multiple Sclerosis
• Randomized Controlled Trial
• Sclerosis

Intervention

Behavioral:
• lavender oil
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.

Locations

Country	Name	City	State
Turkey	Ataturk University	Erzurum

Sponsors (1)

Lead Sponsor	Collaborator
Ataturk University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	two week
Primary	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.	Two week