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Набор скоро начнётся NCT07368374

EFFECTS OF CİTRUS AND CLOVE OİL AROMATHERAPY İN OLDER ADULTS

Без фазы С лечением Aromatherapy

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Intervention Group 1, Intervention Group 2, Placebo Control Group.
Кому может быть актуально
Состояния в реестре: Aromatherapy. Базовые параметры: от 65 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

THE EFFECTS OF CİTRUS AND CLOVE OİL AROMATHERAPY ON FATİGUE LEVEL, SLEEP, AND QUALİTY OF LİFE İN OLDER ADULTS

Обзор

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.

Вмешательства

  • Другое Intervention Group 1
    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.
  • Другое Intervention Group 2
    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.
  • Другое Placebo Control Group
    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.

Первичные конечные точки

  • Change in fatigue level assessed by the Multidimensional Fatigue Inventory (MFI-20) [Срок оценки: 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) [Срок оценки: Baseline and at the end of the 4-week intervention period]
Вторичные конечные точки (1)
  • Change in quality of life assessed by the Older People's Quality of Life Questionnaire-Brief (OPQOL-Brief) [Срок оценки: Baseline and at the end of the 4-week intervention period]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Тройное слепое
Основная цель
Поддерживающая терапия

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07368374 · ERU-SBF-ID-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗