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临床试验/NCT04948931
NCT04948931已完成不适用

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

Abant Izzet Baysal University2 个研究点 分布在 1 个国家目标入组 63 人开始时间: 2021年7月28日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
63
试验地点
2
主要终点
Blessed Orientation Memory Concentration Test (BOMCT)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
65 Years 至 99 Years(Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Blessed Orientation Memory Concentration Test (BOMCT)

时间窗: 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.

Pittsburg Sleep Quality Scale (PUKI)

时间窗: 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.

Spielberger State-Trait Anxiety Scale (STAI)

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Satı Can

Principal Investigator

Abant Izzet Baysal University

研究点 (2)

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