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临床试验/NCT07273825
NCT07273825已完成不适用

The Effect of Geranium Essential Oil Aromatherapy on Fatigue and Sleep Quality in Patients Undergoing Hemodialysis

Universitas Muhammadiyah Surakarta2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2025年1月1日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
90
试验地点
2
主要终点
Change in Fatigue Score (FACIT-F Fatigue Scale)

研究概览

简要总结

Hemodialysis is a life-sustaining therapy for individuals with chronic kidney disease; however, it is often accompanied by adverse effects such as fatigue and poor sleep quality. Fatigue is one of the most frequently reported symptoms among hemodialysis patients and can significantly impair daily functioning, psychosocial wellbeing, and overall quality of life. Sleep disturbances are also common and may further exacerbate physical and emotional stress.

Aromatherapy using essential oils has been explored as a non-pharmacological intervention to reduce fatigue and improve sleep quality. Geranium essential oil contains active compounds such as geraniol, citronellol, and terpineol, which possess relaxing, anti-inflammatory, and analgesic properties. These characteristics indicate its potential to alleviate fatigue and promote better sleep.

This study aims to evaluate the effect of geranium essential oil aromatherapy on fatigue and sleep quality in patients undergoing hemodialysis. The study employs a randomized cross-over design involving 90 participants who meet predetermined inclusion criteria. Fatigue will be assessed using the Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-F), and sleep quality will be measured using the Pittsburgh Sleep Quality Index (PSQI). Assessments will be conducted before and after the intervention period.

The findings of this study are expected to provide scientific evidence supporting the use of geranium essential oil aromatherapy as a safe, accessible complementary therapy that may help reduce fatigue and improve sleep quality among hemodialysis patients.

详细描述

Chronic kidney disease continues to increase worldwide and represents a major contributor to global morbidity and mortality. Hemodialysis is a primary treatment modality for replacing impaired renal function; however, the procedure is associated with various complications, including fatigue and sleep disturbances. Fatigue is one of the most prevalent symptoms among hemodialysis patients, with reported rates ranging from 60% to 97%. It can arise from multiple factors, including anemia, duration of hemodialysis, nutritional status, comorbidities, and uremic neuropathy. Persistent fatigue negatively impacts physical functioning, emotional wellbeing, social interaction, and overall quality of life.

Sleep disturbances are also frequently experienced by patients undergoing hemodialysis. Poor sleep quality may worsen fatigue, impair daytime functioning, and contribute to psychological distress. Given the complex and chronic nature of these symptoms, non-pharmacological interventions are increasingly explored to support symptom management.

Aromatherapy represents one complementary approach that has shown promising effects in managing fatigue and sleep problems. Geranium essential oil contains biologically active compounds-such as geraniol, citronellol, and other terpenoid alcohols-that exhibit relaxing, anti-inflammatory, and analgesic effects. When inhaled, aromatic molecules stimulate olfactory receptors, triggering neural signaling to the limbic system, which plays a key role in emotional regulation, stress response, hormonal balance, and sleep cycles. This mechanism suggests potential therapeutic value for reducing fatigue and improving sleep.

Previous studies have indicated that aromatherapy can benefit hemodialysis patients by reducing fatigue, anxiety, and sleep disturbances, though evidence specifically regarding geranium essential oil remains limited. Therefore, this study aims to generate robust clinical data on the effectiveness of geranium aromatherapy in this population.

A randomized cross-over design will be used, involving 90 hemodialysis patients recruited from multiple dialysis centers. All participants will serve as both control and intervention subjects at different phases of the study, minimizing variability across individuals. Fatigue will be measured using the Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-F), which evaluates physical and mental exhaustion affecting daily life. Sleep quality will be measured using the Pittsburgh Sleep Quality Index (PSQI), assessing multiple components of sleep behavior. Data analysis will include paired t-test, independent t-test, and Chi-Square test with a significance level of p < 0.05.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults aged 18-65 years.
  • Have no visual or hearing impairments.
  • Provide informed consent to participate.
  • Have undergone hemodialysis (HD) for at least 3 months.
  • Regularly receive HD at the study site.
  • Undergo HD at least 2 times per week. 'Experience moderate to severe fatigue.

排除标准

  • Presence of respiratory disease.
  • History of allergy to perfumes or fragrance products.
  • Olfactory impairment (difficulty smelling).
  • Use of other therapies for fatigue during the intervention period

结局指标

主要结局

Change in Fatigue Score (FACIT-F Fatigue Scale)

时间窗: Baseline (pre-intervention) and after each intervention phase (up to 30 days).

Fatigue will be assessed using the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) scale, consisting of 13 items rated on a 0-4 Likert scale. Total scores reflect fatigue severity, with lower scores indicating worse fatigue. Measurements will be taken before and after the intervention and placebo periods in the randomized cross-over design.

次要结局

  • Change in Sleep Quality Score (Pittsburgh Sleep Quality Index - PSQI)(Baseline (pre-intervention) and after each intervention phase (up to 30 days))

研究者

发起方
Universitas Muhammadiyah Surakarta
申办方类型
Other
责任方
Principal Investigator
主要研究者

Fahrun Nur Rosyid

Head of Quality Assurance Group

Universitas Muhammadiyah Surakarta

研究点 (2)

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