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

NCT07756151 — Not applicable, Not yet recruiting, 100 participants, Uludag University

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

Registry	NCT07756151
Status	Not yet recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: single, supportive care
Enrollment	100 (Estimated)
Sponsor	Uludag University (Other)
Conditions	Type 2 Diabetes Mellitus (T2DM)
Interventions	bitter orange oil group (Other)
Dates	start 2026-09-15 (estimated), primary completion 2026-09-30 (estimated), completion 2027-01-20 (estimated), first posted 2026-08-10, last updated 2026-08-10

-Summary

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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+Arms and interventions

Arm	Type	Interventions	Description
Bitter orange oil group	Experimental	Other: bitter orange oil group	Individuals in this group will receive inhalation of bitter orange peel oil for three consecutive nights.
Control group	No intervention		Patients in the control group will undergo the same procedure, but instead of orange oil, they will inhale water into the cotton ball.

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.

+Outcome measures

Primary outcomes

fatigue severity in score [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.
Sleep Quality in score [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

blood sugar level [5 months]: blood sugar level in milligrams per deciliter

+Eligibility

Sex: All, ages: 20 Years to 75 Years

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.