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

NCT ID: NCT05728177

Last Updated: 2023-02-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-10

Study Completion Date

2023-01-05

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.

Conditions

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Inhalation Aromatherapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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STUDY GROUP

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.

Group Type EXPERIMENTAL

Inhalation Aromatherapy

Intervention Type COMBINATION_PRODUCT

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.

Control group

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

Group Type ACTIVE_COMPARATOR

Inhalation Aromatherapy

Intervention Type COMBINATION_PRODUCT

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.

Interventions

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Inhalation Aromatherapy

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.

Intervention Type COMBINATION_PRODUCT

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.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Alexandria University

OTHER

Sponsor Role lead

Responsible Party

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Mahmoud Khedr

Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of Nursing

Alexandria, , Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type BACKGROUND
PMID: 24190780 (View on PubMed)

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.

Reference Type RESULT
PMID: 25114901 (View on PubMed)

Other Identifiers

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1112023

Identifier Type: -

Identifier Source: org_study_id

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