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Clinical Trials/NCT05728177
NCT05728177CompletedNot Applicable

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

Alexandria University1 site in 1 country60 target enrollmentStarted: August 10, 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
60
Locations
1
Primary Endpoint
The Beck Depression Inventory (BDI-II)

Study Overview

Brief Summary

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

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Single (Participant)

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
Yes

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.

Outcomes

Primary Outcomes

The Beck Depression Inventory (BDI-II)

Time Frame: 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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Mahmoud Khedr

Lecturer

Alexandria University

Study Sites (1)

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