EFFECTS OF CİTRUS AND CLOVE OİL AROMATHERAPY İN OLDER ADULTS

NCT07368374 | Not Yet Recruiting DMC

• 1 other identifier: ERU-SBF-ID-01
• Study Type: interventional
• Target: 51
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Aromatherapy

Keywords

aromatherapy; citrus oil; clove oil; older adults

Outcome Measures

Primary Outcomes (2)

• 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.

  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)

  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 Outcomes (1)

• Change in quality of life assessed by the Older People's Quality of Life Questionnaire-Brief (OPQOL-Brief)

  Baseline and at the end of the 4-week intervention period

Study Arms (3)

Citrus Oil Aromatherapy Arm,

EXPERIMENTAL

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).

Other: Intervention Group 1

Clove Oil Aromatherapy Arm

EXPERIMENTAL

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).

Other: Intervention Group 2

Placebo Control Arm

PLACEBO COMPARATOR

Older adults not receiving any aromatherapy intervention (or receiving standard care only).

Other: Placebo Control Group

Interventions

Intervention Group 1 OTHER

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.

Citrus Oil Aromatherapy Arm,

Intervention Group 2 OTHER

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.

Clove Oil Aromatherapy Arm

Placebo Control Group OTHER

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.

Placebo Control Arm

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mersin University: lead

Related Links

• Related Info

Central Study Contacts

ibrahim Duman

CONTACT

03243610001; ibrahimduman@mersin.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Bu çalışmada çift kör tasarım uygulanacaktır. Birinci körleme, katılımcılara yöneliktir; katılımcılar hangi gruba (müdahale ya da placebo kontrol) dâhil edildiklerini bilmeyeceklerdir. İkinci körleme, ön test ve son test verilerini toplayan anketörlere (Anketör 1 ve Anketör 2) yöneliktir; bu anketörler de katılımcıların hangi grupta yer aldığını bilmeyecektir.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: This research is a mixed-pattern study.

Study Record Dates

• First Submitted: September 23, 2025
• First Posted: January 26, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: January 26, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share