Clinical trial NCT05692700: The Effect of Inhaled Lavender and Bergamot Oil on Anxiety and Sleep Quality in Intensive Care Patients.
Official title: THE EFFECT OF INHALED LAVENDER AND BERGAMOT OIL ON ANXIETY AND SLEEP QUALITY OF SURGICAL INTENSIVE CARE PATIENTS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patient Undergoing Surgery
Keywords: Intensive care unit,
sleep quality,
anxiety
aromatherapy,
lavender oil,
bergamot oil
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2023-01-20
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: - 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 purpose: SUPPORTIVE_CARE

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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Insomnia in intensive care patients who have undergone surgery assessed by Richards-Campbell Sleep Scale
timeFrame: 1 year
measure: Insomnia in intensive care patients who have undergone surgery assessed by State-Trait Anxiety Scale
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Çağla
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.