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临床试验/NCT05728177
NCT05728177已完成不适用

Effect of Inhalation Aromatherapy on Anxiety and Depressive Symptoms of Geriatric Patients With Parkinson's Disease

Alexandria University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年8月10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
60
试验地点
1
主要终点
The Beck Depression Inventory (BDI-II)

研究概览

简要总结

The present study aims to:

Investigate the effect of inhalation aromatherapy on anxiety and depressive symptoms of geriatric patients with Parkinson's disease.

Research Hypothesis:

Patients with Parkinson's disease who inhale aromatherapy will exhibit lower anxiety and depressive symptoms than those who didn't inhale it

详细描述

A sample of 60 randomly selected patients with patients Parkinson's disease was included in this study. The study subjects were divided equally into two groups; study (30 patients) and a control group (30 patients) matched as much as possible. Exclusion criteria included patients diagnosed for Parkinson's by a specialist, no use of any complementary alternative medicine methods (herbal medicines and other methods) in the past one week, no use of anxiolytics or antidepressants drugs, no history of respiratory problems as asthma, eczema and allergies to flowers and plants and no smell disorders. Patients who were not willing to participate, not able to provide written consent or not able to communicate coherently and relevantly or showed symptoms of allergy to lavender were excluded from the study.

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
Single (Participant)

入排标准

性别
All
接受健康志愿者

入选标准

  • patients diagnosed for Parkinson's by a specialist

排除标准

  • no use of any complementary alternative medicine methods (herbal medicines and other methods) in the past one week, no use of anxiolytics or antidepressants drugs, no history of respiratory problems as asthma, eczema and allergies to flowers and plants and no smell disorders. Patients who were not willing to participate, not able to provide written consent or not able to communicate coherently and relevantly or showed symptoms of allergy to lavender will be excluded from the study.

结局指标

主要结局

The Beck Depression Inventory (BDI-II)

时间窗: 2 weeks

The scale was developed by (Beck, 1979; Beck, Steer, \& Brown, 1996a; Beck, Ward, Mendelson, Mock, \& Erbaugh, 1961). It is a standardized self-report rating inventory that measures attitudes and symptoms of depression in normal and populations with psychiatric disorders. The BDI-II contains 21 items across two Affective and Somatic subscales. Each item is measured on a 4-point Likert scale from 0 (symptom absent) to 3 (severe symptoms). In addition, items of sleep and appetite were assessed over seven options to determine their hypo or hyperactivity level. The minimum score is 0, and the maximum score is 63, while higher scores indicate greater severity of depressive symptoms. The total score of 0-13 is considered the minimal range of depressive symptoms; 14-19 is mild; 20-28 is moderate, and 29-63 is severe.

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

Mahmoud Khedr

Lecturer

Alexandria University

研究点 (1)

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