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

NCT ID: NCT05692700

Last Updated: 2023-01-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-02

Study Completion Date

2021-11-03

Brief Summary

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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.

Detailed Description

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The universe of the research; Patients who were hospitalized in the Intensive Care Unit of a university hospital in Istanbul between May 2021 and October 2021, and the sample consisted of patients who met the inclusion criteria of the study. Data collection started after obtaining the ethics committee permission, institutional permission, and research permission from the Ministry of Health GETAT Clinical Research Department. A simple computer-assisted randomization method was used to distribute the groups homogeneously. Fifty-four patients who were hospitalized in the reanimation intensive care unit and accepted to participate in the study and met the inclusion criteria were included. The patients were randomly assigned to 3 groups of 18 people, each with distilled water, lavender oil, and bergamot oil. "Patient Information Form", "Patient Follow-up Form", "State-Trait Anxiety Inventory" and "Richard-Campbell Sleep Scale (RCUS)" were used to collect data.

Conditions

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Patient Undergoing Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

\- 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.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Aromatherapy lavender group

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

Group Type EXPERIMENTAL

aromatherapy

Intervention Type OTHER

essential oil application by inhalation

Aromatherapy bergamot group

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.

Group Type EXPERIMENTAL

aromatherapy

Intervention Type OTHER

essential oil application by inhalation

Plasebo group

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo essential oil

Interventions

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aromatherapy

essential oil application by inhalation

Intervention Type OTHER

Placebo

Placebo essential oil

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Istanbul University - Cerrahpasa

OTHER

Sponsor Role lead

Responsible Party

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ÇAĞLA TOPRAK

specialist nurse

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Çağla

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 23476690 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28985917 (View on PubMed)

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.

Reference Type RESULT
PMID: 34690334 (View on PubMed)

Other Identifiers

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E-95961207-604.01.01-1535

Identifier Type: -

Identifier Source: org_study_id

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