The Effect of Inhaled Lavender and Bergamot Oil on Anxiety and Sleep Quality in Intensive Care Patients.

NCT05692700 | Completed

• 1 other identifier: E-95961207-604.01.01-1535
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

This study was carried out as a randomized controlled experimental study to determine the effect of inhaled lavender and bergamot oil on anxiety and sleep quality in patients hospitalized in the intensive care unit who had undergone surgical intervention. The universe of the research; Patients who were hospitalized in an Intensive Care Unit in Istanbul between May 2021 and October 2021, and the sample consisted of patients who met the criteria for inclusion in the study. Fifty-four patients who agreed to participate in the study and met the inclusion criteria were included. Lavender oil or bergamot oil or distilled water was administered to the patients 2 evenings by inhalation.

Conditions

Patient Undergoing Surgery

Keywords

Intensive care unit,; sleep quality,; anxiety; aromatherapy,; lavender oil,; bergamot oil

Outcome Measures

Primary Outcomes (2)

• Insomnia in intensive care patients who have undergone surgery assessed by Richards-Campbell Sleep Scale

  Richards-Campbell Sleep Scale In 1987, Richards K developed the Richard-Campbell Sleep Scale. It is used to evaluate sleep quality in patients and patients in the intensive care unit. The Richards-Campbell Sleep Scale evaluates sleep depth, time to fall asleep and number of awakenings, as well as sleep efficiency and quality with 6 questions. The sixth question was adapted to assess perceived night noise. The first 5 questions are taken into the calculation of the score, the score of the 6th question is not added. It is scored on a visual analog scale ranging from 0 mm to 100 mm, and low scores (0-25 points) represent poor sleep and higher scores (76-100 points) represent good sleep. The mean score of the five items is known as the total score and represents the overall perception of sleep.

  1 year

• Insomnia in intensive care patients who have undergone surgery assessed by State-Trait Anxiety Scale

  State-Trait Anxiety Scale It is a scale used to evaluate the status, continuity and anxiety of patients. It is widely used in hospitals and clinics. The scale is in the form of two separate scales and consists of a total of forty items. The total score calculated from the two scales varies between 80 and 20. The higher the total anxiety score, the higher the anxiety level, and the lower the anxiety level, the lower the anxiety level.

  1 year

Study Arms (3)

Aromatherapy lavender group

EXPERIMENTAL

Stage 1: Patient information form, follow-up form, State Continuity Anxiety Scale, Richard-Campbell Sleep Scale were filled.Stage 2: On the second day of the surgery, at 20:00 in the evening, they were asked to inhale 2-3 drops of lavender essential oil, which was dripped onto the pillow pouches, at 21:00, and these bags were placed 10 cm away from the patient after 20 minutes. These bags were taken from the bedside of the patient at 08:00 in the morning.. Stage 3: Before the evening application, the patient follow-up form, State-Continuity Anxiety Scale, Richard Campbell Sleep Scale were filled and they were asked to inhale 2-3 drops of lavender essential oil, which was dropped on the pillow bags prepared at 20:00, and inhaled at 21:00. Afterwards, these sacs were placed 10 cm away from the patient. These sacs were taken from the bedside of the patient at 08:00 in the morning and the patient follow-up Form, State-Trait Anxiety Scale, Richards-Campbell Sleep Scale were filled

Other: aromatherapy

Aromatherapy bergamot group

EXPERIMENTAL

Stage1:Patient information form, follow-up form, State Continuity Anxiety Scale, Richard Campbell Sleep Scale were filled. Stage 2:On the second day of the surgery, at 20:00 in the evening, they were asked to inhale 2-3 drops of bergamot essential oil, which was dripped onto the pillow pouches,at 21:00, and these bags were placed 10 cm away from the patient after 20 minutes. These bags were taken from the bedside of the patient at 08:00 in the morning.Stage 3:Before the evening application, the patient follow-up form, State-Continuity Anxiety Scale, Richard Campbell Sleep Scale were filled and they were asked to inhale 2-3 drops of bergamot essential oil, which was dropped on the pillow bags prepared at 20:00, and inhaled at 21:00. Afterwards, these sacs were placed 10 cm away from the patient.These sacs were taken from the bedside of the patient at 08:00 in the morning and the patient follow-up Form, State-Trait Anxiety Scale, Richards-Campbell Sleep Scale were filled.

Other: aromatherapy

Plasebo group

PLACEBO COMPARATOR

Stage 1:Patient identification form, follow-up form, State Continuity Anxiety Scale, Richard Campbell Sleep Scale were filled in.Stage2: 2-3 drops of distilled water dripped onto the prepared pillow bags at 21:00 on the second and third days of the surgery by inhalation. They were asked to breathe and after 20 minutes, these sacs were taken and placed 10 cm away from the patient.Stage 3:These sacs were taken from the bedside of the patient at 08:00 in the morning and the patient follow-up form, State-Trait Anxiety Scale, Richards Campbell Sleep Scale were filled again.

Other: Placebo

Interventions

aromatherapy OTHER

essential oil application by inhalation

Aromatherapy bergamot group; Aromatherapy lavender group

Placebo OTHER

Placebo essential oil

Plasebo group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Over 18 years old and under 70 years old.
• Staying in the intensive care unit for at least 3 nights after surgery.
• Ability to communicate ("Richmond Agitation Sedation Scale" +1, 0, -1 points).
• Glasgow coma scale score of 9 or higher.

You may not qualify if:

• Having pain.
• Having any problems with smelling.
• The need for mechanical ventilation.
• Systolic blood pressure below 100 mm Hg.
• Having lung cancer, asthma and chronic obstructive pulmonary disease.
• Having allergies to known plants, flowers and related essential oils.
• Using any medication for anxiety and sleep problems.

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Çağla

Istanbul, Turkey (Türkiye)

Location

Related Publications (3)

• Cho MY, Min ES, Hur MH, Lee MS. Effects of aromatherapy on the anxiety, vital signs, and sleep quality of percutaneous coronary intervention patients in intensive care units. Evid Based Complement Alternat Med. 2013;2013:381381. doi: 10.1155/2013/381381. Epub 2013 Feb 17.

  PMID: 23476690 BACKGROUND

• Muz G, Tasci S. Effect of aromatherapy via inhalation on the sleep quality and fatigue level in people undergoing hemodialysis. Appl Nurs Res. 2017 Oct;37:28-35. doi: 10.1016/j.apnr.2017.07.004. Epub 2017 Aug 1.

  PMID: 28985917 BACKGROUND

• Chen ML, Chen YE, Lee HF. The Effect of Bergamot Essential Oil Aromatherapy on Improving Depressive Mood and Sleep Quality in Postpartum Women: A Randomized Controlled Trial. J Nurs Res. 2022 Apr 1;30(2):e201. doi: 10.1097/jnr.0000000000000459.

  PMID: 34690334 RESULT

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Anxiety Disorders

Interventions

Aromatherapy

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Phytotherapy; Sensory Art Therapies; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: specialist nurse

Model Details: \- Having pain, having smell problems, having systolic blood pressure below 100 mm Hg, having lung cancer, asthma and chronic obstructive pulmonary disease, allergic to known plants, flowers and related essential oils, using any medication for anxiety and sleep problems Lavender and bergamot oil were not administered to the patients by inhalation.

Study Record Dates

• First Submitted: December 16, 2022
• First Posted: January 20, 2023
• Study Start: May 2, 2021
• Primary Completion: October 20, 2021
• Study Completion: November 3, 2021
• Last Updated: January 20, 2023

Record last verified: 2022-12

Locations

TU (1)