Diabetes Mellitus, Type 2NCT04948931
The Effect of Aromatherapy on Cognitive Functions, Anxiety and Sleep
A study testing Lavender aromatherapy and Rosemary aromatherapy in people with Diabetes Mellitus, Type 2, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
Trial 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 more about this study
- Who is it for?
- Ages 65 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Lavender aromatherapy and Rosemary aromatherapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 63 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Jul 2021to 2 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 to 99 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Aromatherapy Application on Cognitive Functions, Anxiety and Sleep Quality in Elderly People With Diabetes
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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Lavender aromatherapy, Rosemary aromatherapy, Control
- Keywords
- diabetes, aromatherapy, elderly, anxiety, cognitive function, sleep
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lavender aromatherapyOther
The application will be once a day, every day for four weeks. Each session will take five minutes.
Rosemary aromatherapyOther
The application will be once a day, every day for four weeks. Each session will take five minutes.
ControlOther
The application will be once a day, every day for four weeks. Each session will take five minutes.
| Study group | Role | What they receive |
|---|---|---|
| Lavender aromatherapy | Experimental | 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. Receives: Other: Lavender aromatherapy |
| Rosemary aromatherapy | Experimental | 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. Receives: Other: Rosemary aromatherapy |
| Control | Placebo comparator | 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. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: four weeks
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.
Measured: four weeks
Spielberger State-Trait Anxiety Scale (STAI)
The scale consists of two parts:
- 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.
- 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.
Measured: four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2021
- Study start28 Jul 2021
- Primary completion28 Feb 2022
- Study completion2 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Abant Izzet Baysal UniversityThe sponsor's other registered studies.
- 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
- Model description
- Three groups: Lavender aromatherapy group, rosemary aromatherapy group and control group
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Satı Can, Abant Izzet Baysal University
- Investigators
- Yasemin YILDIRIM USTA, Prof, Study director, Bolu Abant Izzet Baysal University, Health Sciences Faculty, Department of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04948931
- Sponsor's protocol ID
- AIBU-SBF-SC-02
- Status last verified
- Mar 2022
- First submitted
- 23 Jun 2021
- Last updated
- 3 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Aromatherapy Application on Cognitive Functions, Anxiety and Sleep Quality in Elderly People With Diabetes
- ClinicalTrials.gov ID
- NCT04948931
- Acronym / sponsor ID
- AIBU-SBF-SC-02
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- diabetes, aromatherapy, elderly, anxiety, cognitive function, sleep
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 28 Jul 2021 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 2 Mar 2022 (actual)
- First posted
- 2 Jul 2021 (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.
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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Three groups: Lavender aromatherapy group, rosemary aromatherapy group and control group
| Arm | Type | Receives |
|---|---|---|
| Lavender aromatherapy | Experimental | Other: Lavender aromatherapyAs 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. |
| Rosemary aromatherapy | Experimental | Other: Rosemary aromatherapyAs 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. |
| Control | Placebo comparator | Other: ControlDistilled 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. |
Who may qualify
- Ages
- 65 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (12 listed)
- 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.
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 |
|---|---|---|
| Lavender aromatherapyThe application will be once a day, every day for four weeks. Each session will take five minutes. | Other | Lavender aromatherapy |
| Rosemary aromatherapyThe application will be once a day, every day for four weeks. Each session will take five minutes. | Other | Rosemary aromatherapy |
| ControlThe application will be once a day, every day for four weeks. Each session will take five minutes. | Other | Control |
Primary outcome
Blessed Orientation Memory Concentration Test (BOMCT)
Time frame: four weeks
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.
Pittsburg Sleep Quality Scale (PUKI)
Time frame: four weeks
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.
Spielberger State-Trait Anxiety Scale (STAI)
Time frame: four weeks
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2022.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Yasemin YILDIRIM USTA, Prof study director
Bolu Abant Izzet Baysal University, Health Sciences Faculty, Department of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lavender aromatherapy and Rosemary aromatherapy in people with Diabetes Mellitus, Type 2, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
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 13 inclusion and 12 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: finished, as of the sponsor's last update on 3 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blessed Orientation Memory Concentration Test (BOMCT) (time frame: four weeks). The study lists 3 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 3 Mar 2022.