Aromatherapy With Lavender Essential Oil in Patients With Multiple Sclerosis

NCT05929638 | Unknown

• 1 other identifier: Esin23
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Aromatherapy; Randomized Controlled Trial; Multiple Sclerosis

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

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.

Behavioral: lavender oil

Control

NO INTERVENTION

No intervention will be applied to the control group.

Interventions

lavender oil BEHAVIORAL

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.

Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Having had an attack in the last month,
• Having DSM-IV Axis I disorder,
• Pregnancy,
• Using sleeping pills,
• Breastfeeding

Sponsors & Collaborators

• Ataturk University: lead

Study Sites (1)

Ataturk Unıversity

Erzurum, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

lavender oil

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Nihan Türkoğlu, Assist.Prof.

  Ataturk University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assist Prof.

Study Record Dates

• First Submitted: May 23, 2023
• First Posted: July 3, 2023
• Study Start: January 15, 2023
• Primary Completion: May 15, 2023
• Study Completion: July 15, 2023
• Last Updated: July 3, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)