Aromatherapy With Lavender Essential Oil in Patients With Multiple Sclerosis

Sponsor
Ataturk University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05929638
Collaborator
(none)
70
1
2
5.9
11.8

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: lavender oil
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
70 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Supportive Care
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
Actual Study Start Date :
Jan 15, 2023
Actual Primary Completion Date :
May 15, 2023
Anticipated Study Completion Date :
Jul 15, 2023

Arms and Interventions

Arm Intervention/Treatment
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
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.

No Intervention: Control

No intervention will be applied to the control group.

Outcome Measures

Primary Outcome Measures

  1. Fatigue Severity Scale -FSS [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.

  2. Pittsburgh Sleep Quality Index (PUKI) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ataturk Unıversity Erzurum Turkey

Sponsors and Collaborators

  • Ataturk University

Investigators

  • Study Chair: Nihan Türkoğlu, Assist.Prof., Ataturk University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Esin Kavuran, Assist Prof., Ataturk University
ClinicalTrials.gov Identifier:
NCT05929638
Other Study ID Numbers:
  • Esin23
First Posted:
Jul 3, 2023
Last Update Posted:
Jul 3, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 3, 2023