Type 2 Diabetes Mellitus (T2DM)NCT07756151
THE EFFECT OF BITTER ORANGE (CITRUS AURANTIUM) OIL AROMATHERAPY ON SLEEP QUALITY AND FATIGUE LEVELS
A study testing bitter orange oil group in people with Type 2 Diabetes Mellitus (T2DM), run by Uludag University.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Type 2 Diabetes Mellitus (T2DM)
- What is being tested?
- bitter orange oil group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2026to 20 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
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- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: THE EFFECT OF BITTER ORANGE OIL INHALATION AROMATHERAPY ON SLEEP QUALITY AND FATIGUE LEVELS IN PATIENTS WITH TYPE 2 DIABETES MELLITUS
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.
- Conditions
- Type 2 Diabetes Mellitus (T2DM)
- Being tested
- bitter orange oil group
- Keywords
- fatigue, sleep quality, inhalation of bitter orange oil
- Medical subject headings
- Diabetes Mellitus, Type 2, Fatigue, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bitter orange oil groupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Bitter orange oil group | Experimental | Individuals in this group will receive inhalation of bitter orange peel oil for three consecutive nights. Receives: Other: bitter orange oil group |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
fatigue severity in score
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.
Measured: 5 months
Sleep Quality in score
Sleep Quality Scale: It consists of a total of 18 items. It includes items related to the sleep process and sleep satisfaction.
Measured: 5 months
Secondary outcomes (1)
blood sugar level
blood sugar level in milligrams per deciliter
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2026
- Study start15 Sep 2026 (estimated)
- Primary completion30 Sep 2026 (estimated)
- Study completion20 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes Mellitus (T2DM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uludag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dilek Yilmaz, PhD, Uludag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07756151
- Sponsor's protocol ID
- 2026/03-04
- Status last verified
- Aug 2026
- First submitted
- 4 Aug 2026
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE EFFECT OF BITTER ORANGE OIL INHALATION AROMATHERAPY ON SLEEP QUALITY AND FATIGUE LEVELS IN PATIENTS WITH TYPE 2 DIABETES MELLITUS
- ClinicalTrials.gov ID
- NCT07756151
- Acronym / sponsor ID
- 2026/03-04
- Conditions
- Type 2 Diabetes Mellitus (T2DM)
- Keywords
- fatigue, sleep quality, inhalation of bitter orange oil
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Uludag UniversityUniversity, hospital or other
- Study start
- 15 Sep 2026 (estimated)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 20 Jan 2027 (estimated)
- First posted
- 10 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bitter orange oil group | Experimental | Other: bitter orange oil groupIndividuals 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. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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,
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bitter orange oil groupPatients 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. | Other | Bitter orange oil group |
Primary outcome
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.
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.
1 secondary outcome
blood sugar level
Time frame: 5 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing bitter orange oil group in people with Type 2 Diabetes Mellitus (T2DM), run by Uludag University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dilek Yılmaz, PhD (+902242942454, dilekk@uludag.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fatigue severity in score (time frame: 5 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.