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Completed

NCT Number: NCT05692700

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

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.

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Key information

Conditions

Patient Undergoing Surgery Anxiety Disorders Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Çağla

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Aromatherapy

Other

essential oil application by inhalation

Placebo

Other

Placebo essential oil

Primary outcomes

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

    Time frame: 1 year

    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.

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

    Time frame: 1 year

    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.

Sponsors and collaborators

Lead sponsor

Istanbul University - Cerrahpasa

Other

Registry information

Official study title

THE EFFECT OF INHALED LAVENDER AND BERGAMOT OIL ON ANXIETY AND SLEEP QUALITY OF SURGICAL INTENSIVE CARE PATIENTS

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jan 20, 2023
Registry last updated
Jan 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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