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The Effect of Aromatherapy on Cognitive Functions, Anxiety and Sleep

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Lavender aromatherapy
Rosemary aromatherapy
Control
Sponsored by
Abant Izzet Baysal University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Diabetes Mellitus, Type 2 focused on measuring diabetes, aromatherapy, elderly, anxiety, cognitive function, sleep

Eligibility Criteria

65 Years - 99 Years (Older Adult)All SexesAccepts Healthy Volunteers

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:

  • 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

Sites / Locations

  • SATI CAN

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Lavender aromatherapy

Rosemary aromatherapy

Control

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
June 23, 2021
Last Updated
March 2, 2022
Sponsor
Abant Izzet Baysal University
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1. Study Identification

Unique Protocol Identification Number
NCT04948931
Brief Title
The Effect of Aromatherapy on Cognitive Functions, Anxiety and Sleep
Official Title
The Effect of Aromatherapy Application on Cognitive Functions, Anxiety and Sleep Quality in Elderly People With Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
July 28, 2021 (Actual)
Primary Completion Date
February 28, 2022 (Actual)
Study Completion Date
March 2, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Abant Izzet Baysal University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
diabetes, aromatherapy, elderly, anxiety, cognitive function, sleep

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Three groups: Lavender aromatherapy group, rosemary aromatherapy group and control group
Masking
None (Open Label)
Allocation
Randomized
Enrollment
63 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lavender aromatherapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Rosemary aromatherapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Lavender aromatherapy
Intervention Description
The application will be once a day, every day for four weeks. Each session will take five minutes.
Intervention Type
Other
Intervention Name(s)
Rosemary aromatherapy
Intervention Description
The application will be once a day, every day for four weeks. Each session will take five minutes.
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
The application will be once a day, every day for four weeks. Each session will take five minutes.
Primary Outcome Measure Information:
Title
Blessed Orientation Memory Concentration Test (BOMCT)
Description
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
Title
Pittsburg Sleep Quality Scale (PUKI)
Description
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
Title
Spielberger State-Trait Anxiety Scale (STAI)
Description
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.
Time Frame
four weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yasemin YILDIRIM USTA, Prof
Organizational Affiliation
Bolu Abant Izzet Baysal University, Health Sciences Faculty, Department of Nursing
Official's Role
Study Director
Facility Information:
Facility Name
SATI CAN
City
Bolu
State/Province
Center
ZIP/Postal Code
14100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effect of Aromatherapy on Cognitive Functions, Anxiety and Sleep

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