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

Study Overview
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Brief Summary
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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

Detailed Description
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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.

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

Conditions
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Inhalation Aromatherapy

Intervention / Treatment
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* Combination Product: Inhalation Aromatherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients diagnosed for Parkinson's by a specialist Exclusion Criteria: 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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: STUDY GROUP<br>Patients' medical charts in the outpatient clinic were reviewed to identify those who meet the inclusion criteria. Patients who meet the predetermined inclusion criteria were recruited in the study using simple randomization technique using computer-generated sequence technique to pick up these patients. After simple sampling and dividing patients into two groups of study and control. Patients from the study and control groups were interviewed individually by the researcher to apply the study tools The program of intervention took four-weeks for each patient (total eight sessions- four outpatient sessions and four home-based sessions- two sessions per week- one outpatient and one home session/week). The outpatient sessions were done once per week during the patient visit to the outpatient clinic, as the patients visited the clinic 4 times/ month. | Combination Product: Inhalation Aromatherapy<br>* Aromatherapy is safe, well prepared mixture used in the study that prepared by professor of pharmacology, faculty of pharmacy by mixing lavender essential oil and lavender hydrolate Patients' medical charts in the outpatient clinic were reviewed to identify those who meet the inclusion criteria. Patients who meet the predetermined inclusion criteria were recruited in the study using simple randomization technique using computer-generated sequence technique to pick up these patients. After simple sampling and dividing patients into two groups of study and control. Patients from the study and control groups were interviewed individually by the researcher to apply the study tools as a pretest. Aromatherapy intervention was carried out for patients in the study group while those in the control group were left without any intervention to undergo the usual outpatient routine care.<br>|
| Active Comparator: Control group<br>Patients in this control group will be left without any intervention to undergo the usual outpatient routine care. | Combination Product: Inhalation Aromatherapy<br>* Aromatherapy is safe, well prepared mixture used in the study that prepared by professor of pharmacology, faculty of pharmacy by mixing lavender essential oil and lavender hydrolate Patients' medical charts in the outpatient clinic were reviewed to identify those who meet the inclusion criteria. Patients who meet the predetermined inclusion criteria were recruited in the study using simple randomization technique using computer-generated sequence technique to pick up these patients. After simple sampling and dividing patients into two groups of study and control. Patients from the study and control groups were interviewed individually by the researcher to apply the study tools as a pretest. Aromatherapy intervention was carried out for patients in the study group while those in the control group were left without any intervention to undergo the usual outpatient routine care.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Beck Depression Inventory (BDI-II) | 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. | 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Inhalation Aromathrapy, Anxiety, Depressive Symptoms, Parkinson's Disease