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NCT Number: NCT07756151

THE EFFECT OF BITTER ORANGE (CITRUS AURANTIUM) OIL AROMATHERAPY ON SLEEP QUALITY AND FATIGUE LEVELS

This study will be conducted to examine the effect of bitter orange oil inhalation aromatherapy on sleep quality and fatigue levels in patients with Type 2 Diabetes Mellitus (DM). The study will be conducted in the Endocrinology clinic of a university hospital in Türkiye. The research sample will consist of 100 adult patients. Patients will be randomly divided into two groups: the intervention and control groups. Patients in the intervention group will have three drops of bitter orange oil placed on a small cotton ball each night close to bedtime for three consecutive days. They will then hold the cotton ball 5 cm away from their nose and inhale it for one minute while breathing normally. After three consecutive nights of this procedure, sleep quality and fatigue levels will be measured on the morning of the fourth day. Patients in the control group will undergo the same procedure, but instead of orange oil, they will inhale water into the cotton ball.

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Key information

Conditions

Type 2 Diabetes Mellitus (T2DM) Diabetes Mellitus Diabetes Mellitus, Type 2 Dyssomnias Endocrine System Diseases Fatigue Glucose Metabolism Disorders Mental Disorders Metabolic Diseases Nervous System Diseases Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • being over the age of 19,
  • having no communication problem, and voluntarily agreeing to participate in the research,
  • having been admitted to the clinic at least 24 hours ago,
  • not having a diagnosed sleep disorder,
  • not having a psychiatric disorder requiring treatment,
  • not using narcotic drugs in the last 4 hours,
  • not eating two hours before going to bed at night,
  • not being pregnant,
  • not smoking,
  • not diagnosed acute rhinitis, sinusitis, or history of loss of smell.

Exclusion criteria

  • being under the age of 19,
  • not being conscious, refusing to participate in the research or opting to leave the study at any point,
  • having a diagnosed sleep disorder.

Treatment and study plan

bitter orange oil group

Other

Patients in the intervention group will have three drops of bitter orange oil placed on a small cotton ball each night close to bedtime for three consecutive days. They will then hold the cotton ball 5 cm away from their nose and inhale it for one minute while breathing normally. After three consecutive nights of this procedure, sleep quality and fatigue levels will be measured on the morning of the fourth day.

Primary outcomes

  1. fatigue severity in score

    Time frame: 5 months

    The Fatigue Severity Scale is a one-dimensional scale where individuals indicate how much they agree with each item by choosing a number from 1 to 7. 1 means completely disagree, and 7 means completely agree. The scale consists of 9 questions, with a score range of 9-63. A score of 36 or higher indicates severe fatigue. The total score is calculated by averaging the scores of all 9 items.

  2. Sleep Quality in score

    Time frame: 5 months

    Sleep Quality Scale: It consists of a total of 18 items. It includes items related to the sleep process and sleep satisfaction.

Secondary outcomes

  1. blood sugar level

    Time frame: 5 months

    blood sugar level in milligrams per deciliter

Study contacts

Contact information is provided by the study sponsor or research team.

Dilek Yılmaz, PhD

CONTACT

[email protected]

+902242942454

Sponsors and collaborators

Lead sponsor

Uludag University

Other

Registry information

Official study title

THE EFFECT OF BITTER ORANGE OIL INHALATION AROMATHERAPY ON SLEEP QUALITY AND FATIGUE LEVELS IN PATIENTS WITH TYPE 2 DIABETES MELLITUS

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Aug 10, 2026
Registry last updated
Aug 10, 2026

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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