EFFECTS OF CİTRUS AND CLOVE OİL AROMATHERAPY İN OLDER ADULTS
ConditionAromatherapy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorMersin University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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)
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Intervention Group 1
Other interventionIntervention 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.
Intervention Group 2
Other interventionThis 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 Control Group
Other interventionThis 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.
Treatment groups
51 Participants
are divided into 3 treatment groupsGroup A: Citrus Oil Aromatherapy Arm,Experimental treatment 1 intervention
Group B: Clove Oil Aromatherapy ArmExperimental treatment 1 intervention
Group C: Placebo Control ArmPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in fatigue level assessed by the Multidimensional Fatigue Inventory (MFI-20)
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.
Time frame
Baseline and at the end of the 4-week intervention period2
Change in insomnia complaints and sleep quality assessed by the Basic Insomnia and Sleep Quality Scale (BaSIQS)
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.
Time frame
Baseline and at the end of the 4-week intervention periodSecondary outcomes
1
Change in quality of life assessed by the Older People's Quality of Life Questionnaire-Brief (OPQOL-Brief)
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.
Time frame
Baseline and at the end of the 4-week intervention periodLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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