The Effect of Aromatherapy on Cognitive Functions, Anxiety and Sleep

NCT04948931 | Completed

• 1 other identifier: AIBU-SBF-SC-02
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

diabetes; aromatherapy; elderly; anxiety; cognitive function; sleep

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  four weeks

• 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.

  four weeks

Study Arms (3)

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.

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.

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.

Other: Control

Interventions

Lavender aromatherapy OTHER

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

Lavender aromatherapy

Rosemary aromatherapy OTHER

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

Rosemary aromatherapy

Control OTHER

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

Control

Eligibility Criteria

• Age: 65 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abant Izzet Baysal University: lead

Study Sites (1)

SATI CAN

Bolu, Center, 14100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus; Anxiety Disorders

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Mental Disorders

Study Officials

• Yasemin YILDIRIM USTA, Prof

  Bolu Abant Izzet Baysal University, Health Sciences Faculty, Department of Nursing

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Three groups: Lavender aromatherapy group, rosemary aromatherapy group and control group

Study Record Dates

• First Submitted: June 23, 2021
• First Posted: July 2, 2021
• Study Start: July 28, 2021
• Primary Completion: February 28, 2022
• Study Completion: March 2, 2022
• Last Updated: March 3, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)