The Effect of Aromatherapy on Cognitive Functions, Anxiety and Sleep

March 2, 2022 updated by: Satı Can, Abant Izzet Baysal University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

63

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Center
      • Bolu, Center, Turkey, 14100
        • SATI CAN

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 99 years (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
The application will be once a day, every day for four weeks. Each session will take five minutes.
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
The application will be once a day, every day for four weeks. Each session will take five minutes.
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
The application will be once a day, every day for four weeks. Each session will take five minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
four weeks
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.
four weeks
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.
four weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abant Izzet Baysal University

Investigators

  • Study Director: Yasemin YILDIRIM USTA, Prof, Bolu Abant Izzet Baysal University, Health Sciences Faculty, Department of Nursing

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 28, 2021

Primary Completion (Actual)

February 28, 2022

Study Completion (Actual)

March 2, 2022

Study Registration Dates

First Submitted

June 23, 2021

First Submitted That Met QC Criteria

June 23, 2021

First Posted (Actual)

July 2, 2021

Study Record Updates

Last Update Posted (Actual)

March 3, 2022

Last Update Submitted That Met QC Criteria

March 2, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AIBU-SBF-SC-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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