NCT07756151

Brief 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
4mo left

Started Sep 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 4, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 10, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

September 15, 2026

Expected
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2026

4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2027

Last Updated

August 10, 2026

Status Verified

August 1, 2026

Enrollment Period

15 days

First QC Date

August 4, 2026

Last Update Submit

August 4, 2026

Conditions

Type 2 Diabetes Mellitus (T2DM)

Keywords

fatiguesleep qualityinhalation of bitter orange oil

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    5 months

Secondary Outcomes (1)

  • blood sugar level

    5 months

Study Arms (2)

Bitter orange oil group

EXPERIMENTAL

Individuals in this group will receive inhalation of bitter orange peel oil for three consecutive nights.

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.

Interventions

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.

Bitter orange oil group

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus, Type 2FatigueSleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Central Study Contacts

Dilek Yılmaz, PhD

CONTACT

+902242942454dilekk@uludag.edu.tr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Bursa Uludag University, Department of Nursing

Study Record Dates

First Submitted

August 4, 2026

First Posted

August 10, 2026

Study Start (Estimated)

September 15, 2026

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

January 20, 2027

Last Updated

August 10, 2026

Record last verified: 2026-08