THE EFFECTS OF CİTRUS AND CLOVE OİL AROMATHERAPY ON FATİGUE LEVEL, SLEEP, AND QUALİTY OF LİFE İN OLDER ADULTS
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 51
- 主要终点
- Change in fatigue level assessed by the Multidimensional Fatigue Inventory (MFI-20)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
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.
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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).
干预措施: Intervention Group 1 (Other)
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).
干预措施: Intervention Group 2 (Other)
Placebo Control Arm
Older adults not receiving any aromatherapy intervention (or receiving standard care only).
干预措施: Placebo Control Group (Other)
结局指标
主要结局
Change in fatigue level assessed by the Multidimensional Fatigue Inventory (MFI-20)
时间窗: 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.
Change in insomnia complaints and sleep quality assessed by the Basic Insomnia and Sleep Quality Scale (BaSIQS)
时间窗: 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.
次要结局
- 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)