- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07368374
EFFECTS OF CİTRUS AND CLOVE OİL AROMATHERAPY İN OLDER ADULTS (ARTICLE)
THE EFFECTS OF CİTRUS AND CLOVE OİL AROMATHERAPY ON FATİGUE LEVEL, SLEEP, AND QUALİTY OF LİFE İN OLDER ADULTS
This study aimed to determine the effects of citrus and clove oil aromatherapy, administered via inhalation (2 drops, 2 minutes, 3 times a week for one month), on fatigue level, sleep quality, and quality of life in older adults.
Research Hypotheses
H11: Inhalation aromatherapy with 2 drops of pure citrus oil administered for 2 minutes, 3 times a week, for a total of 12 sessions over one month is effective on fatigue level in older adults.
H01: Inhalation aromatherapy with 2 drops of pure citrus oil administered for 2 minutes, 3 times a week, for a total of 12 sessions over one month is not effective on fatigue level in older adults.
H12: Inhalation aromatherapy with 2 drops of pure citrus oil administered for 2 minutes, 3 times a week, for a total of 12 sessions over one month is effective on sleep quality in older adults.
H02: Inhalation aromatherapy with 2 drops of pure citrus oil administered for 2 minutes, 3 times a week, for a total of 12 sessions over one month is not effective on sleep quality in older adults.
H13: Inhalation aromatherapy with 2 drops of pure citrus oil administered for 2 minutes, 3 times a week, for a total of 12 sessions over one month is effective on quality of life in older adults.
H03: Inhalation aromatherapy with 2 drops of pure citrus oil administered for 2 minutes, 3 times a week, for a total of 12 sessions over one month is not effective on quality of life in older adults.
H14: Inhalation aromatherapy with 2 drops of pure clove oil administered for 2 minutes, 3 times a week, for a total of 12 sessions over one month is effective on fatigue level in older adults.
H04: Inhalation aromatherapy with 2 drops of pure clove oil administered for 2 minutes, 3 times a week, for a total of 12 sessions over one month is not effective on fatigue level in older adults.
H15: Inhalation aromatherapy with 2 drops of pure clove oil administered for 2 minutes, 3 times a week, for a total of 12 sessions over one month is effective on sleep quality in older adults.
H05: Inhalation aromatherapy with 2 drops of pure clove oil administered for 2 minutes, 3 times a week, for a total of 12 sessions over one month is not effective on sleep quality in older adults.
H16: Inhalation aromatherapy with 2 drops of pure clove oil administered for 2 minutes, 3 times a week, for a total of 12 sessions over one month is effective on quality of life in older adults.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: ibrahim Duman
- Phone Number: 03243610001
- Email: ibrahimduman@mersin.edu.tr
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Individuals who are: • 65 years of age or older
- Registered at the 60+ Refreshment University campus
- Can understand and communicate in Turkish
- Have a score of ≥24 on the Standardized Mini Mental State Examination (SMMT)
- Have a visual similarity scale (VAS-S) score of 4 or higher for sleep problems within the past week
- Have a visual similarity scale (VAS-F) score of 4 or higher for fatigue level within the past week
- Have agreed to participate in the study will be included in the study.
Exclusion Criteria:
- Those with a known allergy/sensitivity to citrus or clove oil,
- Those diagnosed with any respiratory disease (asthma, COPD, etc.),
- Those with any health condition that impairs their ability to smell will not be included in the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Citrus Oil Aromatherapy Arm,
Older adults receiving inhalation aromatherapy with 2 drops of pure citrus oil for 2 minutes, 3 times a week, for one month (12 sessions in total).
|
Intervention 1 (Citrus Oil) Group: This group receives treatment 3 times a week (Mondays, Wednesdays, and Fridays between 13:00 and 14:00), for a total of 12 sessions over one month, with 2 drops of citrus oil applied to a 6x6 cm gauze pad for 2 minutes in each session.
|
|
Experimental: Clove Oil Aromatherapy Arm
Older adults receiving inhalation aromatherapy with 2 drops of pure clove oil for 2 minutes, 3 times a week, for one month (12 sessions in total).
|
This group undergoes a total of 12 sessions over one month, 3 times a week (Mondays, Wednesdays, and Fridays between 13:00 and 14:00), each session involves applying 2 drops of clove oil for 2 minutes, using a 6x6 cm gauze pad in each application.
|
|
Placebo Comparator: Placebo Control Arm
Older adults not receiving any aromatherapy intervention (or receiving standard care only).
|
This group undergoes a treatment three times a week (Mondays, Wednesdays, and Fridays between 13:00 and 14:00), a total of 12 sessions over one month, and in each session, 2 drops of almond oil are applied to a 6x6 cm gauze pad for 2 minutes.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in fatigue level assessed by the Multidimensional Fatigue Inventory (MFI-20)
Time Frame: Baseline and at the end of the 4-week intervention period
|
Fatigue level will be assessed using the Multidimensional Fatigue Inventory (MFI-20), a validated self-report questionnaire.
Prior to the initiation of the aromatherapy intervention, baseline MFI-20 data will be collected through face-to-face interviews conducted by Assessor 1.
Following the completion of the four-week intervention period, the MFI-20 will be re-administered through face-to-face interviews by Assessor 2. The primary outcome will be the mean change in total MFI-20 score from baseline to post-intervention.
Comparisons will be conducted between the intervention groups and the placebo control group.
|
Baseline and at the end of the 4-week intervention period
|
|
Change in insomnia complaints and sleep quality assessed by the Basic Insomnia and Sleep Quality Scale (BaSIQS)
Time Frame: Baseline and at the end of the 4-week intervention period
|
Insomnia complaints and sleep quality will be assessed using the Basic Insomnia and Sleep Quality Scale (BaSIQS), a validated self-report questionnaire.
Baseline measurements will be collected through face-to-face interviews conducted by Assessor 1 prior to the initiation of the aromatherapy intervention.
Following the completion of the four-week intervention period, the BaSIQS will be re-administered through face-to-face interviews by Assessor 2. The primary outcome will be the mean change in total BaSIQS score from baseline to post-intervention.
Comparisons will be made between the aromatherapy intervention groups and the placebo control group.
|
Baseline and at the end of the 4-week intervention period
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in quality of life assessed by the Older People's Quality of Life Questionnaire-Brief (OPQOL-Brief)
Time Frame: Baseline and at the end of the 4-week intervention period
|
Quality of life will be assessed using the Older People's Quality of Life Questionnaire-Brief (OPQOL-Brief), a validated self-report instrument.
Baseline measurements will be collected through face-to-face interviews conducted by Assessor 1 prior to the initiation of the aromatherapy intervention.
Following the completion of the four-week intervention period, the OPQOL-Brief will be re-administered through face-to-face interviews by Assessor 2. The primary outcome will be the mean change in total OPQOL-Brief score from baseline to post-intervention.
Comparisons will be made between the aromatherapy intervention groups and the placebo control group.
|
Baseline and at the end of the 4-week intervention period
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- ERU-SBF-ID-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Study Data/Documents
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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