CClinicalTrials.gg
CompletedNCT04948931Updated Mar 3, 2022

The Effect of Aromatherapy on Cognitive Functions, Anxiety and Sleep

An interventional study of Lavender aromatherapy and Rosemary aromatherapy in Diabetes Mellitus, Type 2, sponsored by Abant Izzet Baysal University. Completed at 1 site in Turkey. Open to participants aged 65 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-03-03.

Sponsored by Abant Izzet Baysal University · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
63
Allocation
Randomized
Ages
65 Years to 99 Years
Sex
All
01

Study summary

The aim of this study is to determine the effect of aromatherapy application on cognitive functions, anxiety and sleep quality in elderly people with diabetes.

Read the detailed description

In addition to its physiological complications, diabetes is a disease that has negative effects on cognitive functions and is accompanied by anxiety and sleep problems. These problems negatively affect diabetes management and glycemic control. Ensuring glycemic control is the most important goal of diabetes treatment. The chronic and progressive nature of diabetes, the continuous increase in the number of individuals with diabetes and the accompanying problems lead the individual to seek alternative treatment methods in addition to clinical medical treatment. When the literature is examined, it is seen that aromatherapy is used in many clinical applications. Studies have shown the positive effects of lavender and rosemary and aromatherapy on cognitive functions, anxiety and sleep problems. However, no comprehensive studies on its effects in the elderly with diabetes were found. This study was planned to determine the effect of aromatherapy application on cognitive functions, anxiety and sleep quality in elderly people with diabetes.

02

Conditions studied

  • Diabetes Mellitus, Type 2

Keywords

  • diabetes
  • aromatherapy
  • elderly
  • anxiety
  • cognitive function
  • sleep
03

In context

Diabetes Mellitus, Type 2

9,362 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,317 are open to participants now.

This study's enrollment of 63 is below the median of 80 across 7,528 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

Abant Izzet Baysal University is the lead sponsor of 242 studies on the registry; 64 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Who agreed to participate in the research
  • Those aged 65 and over
  • Diagnosed with diabetes for at least 1 year
  • Having no problems with hearing, speaking, seeing and smelling in a way that hinders communication
  • Those who have no problem in verbal communication
  • Passing the sense of smell test
  • Not taking current anxiolytic or hypnotic therapy
  • Not diagnosed with a psychiatric illness and without a diagnosis of mental disability
  • Do not have any respiratory system disease such as asthma, COPD and allergic skin disease
  • No diagnosis of epilepsy disease
  • No known allergy to essential oils to be used in the application
  • Those who did not use any of the other complementary and integrative application methods at the time of the study.
  • Not using sleeping pills

Exclusion criteria

Exclusion Criteria:

  • Failure to make interventions within the specified time
  • Not attending one of the sessions
  • Unwillingness to cooperate with the study
  • In addition to existing diseases, respiratory system diseases such as asthma, COPD and allergic diseases
  • Known allergy to essential oils and oil used in the study.
  • Failed to pass the sense of smell test.
  • Receiving anxiolytic or hypnotic therapy
  • Those with a diagnosis of psychiatric illness
  • Those with a diagnosis of epilepsy disease
  • Speech, hearing and vision loss
  • Those who do not agree to participate in the research
  • Living alone
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
63 participants (actual)

Study arms

  • Experimental
    Lavender aromatherapy

    As an intervention to this group, lavender application will be made by inhalation. Participants will apply lavender oil in half an hour before going to bed every night for a month under the supervision of a relative. The application will be done by dripping three drops on cotton, holding it 5-10 cm away from the nose for five minutes and breathing normally.

    Other: Lavender aromatherapy

  • Experimental
    Rosemary aromatherapy

    As an intervention to this group, rosemary application will be made by inhalation. Participants will apply rosemary oil in half an hour before going to bed every night for a month under the supervision of a relative. The application will be done by dripping three drops on cotton, holding it 5-10 cm away from the nose for five minutes and breathing normally.

    Other: Rosemary aromatherapy

  • Placebo comparator
    Control

    Distilled water will be used for the application to this group. The application will be made every night for a month, half an hour before going to bed, under the supervision of a relative. Participants will apply distilled water by dropping three drops on cotton, holding it 5-10 cm away from the nose, for five minutes and breathing normally.

    Other: Control

Interventions

  • OtherLavender aromatherapy

    The application will be once a day, every day for four weeks. Each session will take five minutes.

  • OtherRosemary aromatherapy

    The application will be once a day, every day for four weeks. Each session will take five minutes.

  • OtherControl

    The application will be once a day, every day for four weeks. Each session will take five minutes.

06

What researchers measure

Primary outcomes

  1. Blessed Orientation Memory Concentration Test (BOMCT)

    The scale consists of 6 items. It is a test that evaluates the cognitive functions of orientation, memory and concentration. To reach a total score of 28 (worst score) in the scale, the number of errors in the scale in each item is multiplied by the weighted coefficients determined. In the scale evaluation, a point is given to each error in the answers given by the individual, and the total score is obtained by multiplying the scores given differently by the weight points determined differently for each question. An increase in the score indicates a decline in cognitive functions.

    Time frame: four weeks

  2. Pittsburg Sleep Quality Scale (PUKI)

    The scale includes a total of 24 questions and 19 questions are self-report questions and are answered by the individual. Five questions are answered by the spouse or roommate and are not included in the scoring. The 18 items participating in the scoring were grouped into seven components. Each component is evaluated between 0-3 points (0: good, 3: bad). The total score ranges from 0 to 21 and consists of the sum of all components. A high total scale score indicates poor sleep quality. If the total score is 5 or more, it is classified as poor sleep quality, if the total score is between 0-4, the sleep quality is good, and between 5-21, the sleep quality is poor.

    Time frame: four weeks

  3. Spielberger State-Trait Anxiety Scale (STAI)

    The scale consists of two parts: 1. State Anxiety Scale: It is a 4-point Likert-type scale consisting of 20 questions aiming to measure how individuals feel themselves at the moment. The scores obtained from the scale range from 20 to 80, with high scores indicating high anxiety and low scores indicating low anxiety levels. 0-19 points from the scale indicate that there is no anxiety, 20-39 points indicate mild, 40-59 points moderate, 60-79 points indicate the level of severe anxiety, and a score above 60 indicates the need for professional help. 2. Trait Anxiety Scale: It indicates how the person feels during the process, regardless of the situation and conditions. The scores obtained from the scale vary between 20 and 80, and a high score indicates a high level of anxiety, and a low score indicates a low level of anxiety. 0-30 indicates low anxiety, 31-49 indicates moderate anxiety, and 50 and higher indicates high anxiety.

    Time frame: four weeks

07

Study locations

1 site
  • SATI CAN
    Bolu, Center 14100, Turkey
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 3, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04948931
Lead sponsor
Abant Izzet Baysal University
Responsible party
Satı Can (Principal Investigator, Abant Izzet Baysal University) — Principal investigator
First posted
Jul 2, 2021
Start date
Jul 28, 2021
Primary completion
Feb 28, 2022
Completion
Mar 2, 2022
Last update
Mar 3, 2022

Study contacts

Yasemin YILDIRIM USTA, Prof
study director · Bolu Abant Izzet Baysal University, Health Sciences Faculty, Department of Nursing

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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