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Completed

NCT Number: NCT04948931

The Effect of Aromatherapy on Cognitive Functions, Anxiety and Sleep

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Anxiety Disorders Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Mental Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

65 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

SATI CAN

Bolu, Center, 14100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lavender aromatherapy

Other

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

Rosemary aromatherapy

Other

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

Control

Other

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

Primary outcomes

  1. 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.

  2. 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.

  3. Spielberger State-Trait Anxiety Scale (STAI)

    Time frame: four weeks

    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.

Sponsors and collaborators

Lead sponsor

Abant Izzet Baysal University

Other

Registry information

Official study title

The Effect of Aromatherapy Application on Cognitive Functions, Anxiety and Sleep Quality in Elderly People With Diabetes

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 2, 2021
Registry last updated
Mar 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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