The Effect of Aromatherapy on Cognitive Functions, Anxiety and Sleep

NCT ID: NCT04948931

Last Updated: 2022-03-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-28
• Study Completion Date: 2022-03-02

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.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Lavender aromatherapy

Intervention Type: OTHER

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

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.

Group Type: EXPERIMENTAL

Rosemary aromatherapy

Intervention Type: OTHER

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

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.

Group Type: PLACEBO_COMPARATOR

Control

Intervention Type: OTHER

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

Interventions

Lavender aromatherapy

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

Intervention Type: OTHER

Rosemary aromatherapy

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

Intervention Type: OTHER

Control

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Abant Izzet Baysal University

OTHER

Sponsor Role: lead

Responsible Party

Satı Can

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yasemin YILDIRIM USTA, Prof

Role: STUDY_DIRECTOR

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

Locations

SATI CAN

Bolu, Center, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

AIBU-SBF-SC-02

Identifier Type: -

Identifier Source: org_study_id