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

NCT05728177 | Completed

• 1 other identifier: 1112023
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Inhalation Aromatherapy

Keywords

Inhalation Aromathrapy, Anxiety, Depressive Symptoms, Parkinson's Disease

Outcome Measures

Primary Outcomes (1)

• 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

Other Outcomes (1)

• Beck Anxiety Inventory (BAI)

  2 weeks

Study Arms (2)

STUDY GROUP

EXPERIMENTAL

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

Control group

ACTIVE COMPARATOR

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

Combination Product: Inhalation Aromatherapy

Interventions

Inhalation Aromatherapy 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; STUDY GROUP

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• patients diagnosed for Parkinson's by a specialist

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Faculty of Nursing

Alexandria, Egypt

Location

Related Publications (2)

• 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.

  PMID: 24190780 BACKGROUND

• 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.

  PMID: 25114901 RESULT

MeSH Terms

Conditions

Anxiety Disorders; Depression; Parkinson Disease

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: February 4, 2023
• First Posted: February 15, 2023
• Study Start: August 10, 2022
• Primary Completion: December 10, 2022
• Study Completion: January 5, 2023
• Last Updated: February 15, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)