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

Primary Purpose

Inhalation Aromatherapy

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Inhalation Aromatherapy
Sponsored by
Alexandria University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Inhalation Aromatherapy focused on measuring Inhalation Aromathrapy, Anxiety, Depressive Symptoms, Parkinson's Disease

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Faculty of Nursing

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

STUDY GROUP

Control group

Arm Description

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.

Patients in this control group will be left without any intervention to undergo the usual outpatient routine care.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
February 4, 2023
Last Updated
February 4, 2023
Sponsor
Alexandria University
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1. Study Identification

Unique Protocol Identification Number
NCT05728177
Brief Title
Effect of Inhalation Aromatherapy on Anxiety and Depressive Symptoms of Geriatric Patients With Parkinson's Disease
Official Title
Effect of Inhalation Aromatherapy on Anxiety and Depressive Symptoms of Geriatric Patients With Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
August 10, 2022 (Actual)
Primary Completion Date
December 10, 2022 (Actual)
Study Completion Date
January 5, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Alexandria University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inhalation Aromatherapy
Keywords
Inhalation Aromathrapy, Anxiety, Depressive Symptoms, Parkinson's Disease

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
STUDY GROUP
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Patients in this control group will be left without any intervention to undergo the usual outpatient routine care.
Intervention Type
Combination Product
Intervention Name(s)
Inhalation Aromatherapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
The Beck Depression Inventory (BDI-II)
Description
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.
Time Frame
2 weeks
Other Pre-specified Outcome Measures:
Title
Beck Anxiety Inventory (BAI)
Description
The Beck Anxiety Inventory (BAI) was developed in 1988 and consists of 21 items with a Likert scale ranging from 0 to 3 and raw scores ranging from 0 to 63 (Beck, Epstein, Brown, & Steer, 1988). The questions used in this measure ask about common symptoms of anxiety that the subject has had during the past week (including the day you take it). The BAI contains 21 questions, each answer being scored on a scale value of 0 (not at all) to 3 (severely). Higher total scores indicate more severe anxiety symptoms. The scores are classified as low anxiety (0-21), moderate anxiety (22-35) and potentially concerning levels of anxiety for score of 36 and above
Time Frame
2 weeks

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Faculty of Nursing
City
Alexandria
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24190780
Citation
Marsh L. Depression and Parkinson's disease: current knowledge. Curr Neurol Neurosci Rep. 2013 Dec;13(12):409. doi: 10.1007/s11910-013-0409-5.
Results Reference
background
PubMed Identifier
25114901
Citation
Tang SK, Tse MY. Aromatherapy: does it help to relieve pain, depression, anxiety, and stress in community-dwelling older persons? Biomed Res Int. 2014;2014:430195. doi: 10.1155/2014/430195. Epub 2014 Jul 13.
Results Reference
result

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

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