The Effects of an App-based Acupressure Intervention on Alleviating Fatigue, Pruritus, and Sleep Quality Among Hemodialysis Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Fatigue
研究概览
简要总结
Objectives: To evaluate the effectiveness of an app-based self-guided acupressure intervention in alleviating fatigue and pruritus, and in improving sleep quality among hemodialysis patients.
Design and subjects: The parallel randomized controlled trial will be employed in one hospital. Block randomization in a 1:1 ratio will be used to assign the patients to the intervention and control groups. It is estimated that 50 to 100 participants receiving hemodialysis will be recruited.
Instrument: The demographic and health-related information questionnaire, the Post-dialysis Fatigue (PDF), 5-D Itch, and Pittsburgh Sleep Quality Index will be used in this study.
Interventions: The intervention group will use an app-based self-guided acupressure program to do the acupressure by themselves once daily for 4 weeks. Participants in the control group will receive usual care and no other intervention.
Data analysis: Both intention-to-treat and per-protocol analysis approaches will be performed. Generalized Estimating Equations (GEE) analysis will be used to assess the effectiveness of the interventions. Sensitivity analysis will be conducted to assess the impact of missing data on the treatment effect if necessary.
Expected outcomes: Participants in the intervention group will know how to do the self-guided acupressure by themselves. If the intervention is effective, the App can be introduced to the hemodialysis patients who need it.
详细描述
Introduction Fatigue is a multidimensional construct, encompassing behavioral, emotional, sensory, and cognitive domains (Joshwa et al., 2020). Among patients receiving hemodialysis (HD), fatigue is one of the most commonly reported and debilitating symptoms (Bossola et al., 2023). This symptom profoundly affects patients' functional capacity, psychological well-being, and overall quality of life (Bossola et al., 2023).
The effectiveness of both pharmacological and non-pharmacological interventions for managing fatigue in hemodialysis patients remains inconsistent due to a lack of high-quality evidence (Natale et al., 2023). Pharmacological options, such as erythropoiesis-stimulating agents, serotonin reuptake inhibitors, beta-blockers, anabolic steroids, and glucose-enriched dialysate, have produced mixed results (Natale et al., 2023). Similarly, non-pharmacological approaches, including amino acid supplementation, music therapy, meditation, cognitive-behavioral therapy, exercise, nutritional support, and light therapy, have shown limited and inconclusive benefits (Natale et al., 2023). Other interventions, such as increasing the frequency of dialysis sessions, adjusting blood flow rates, and home blood pressure monitoring, have also been explored, but lack strong supporting evidence (Natale et al., 2023). Given the complex nature of fatigue in this population, further well-designed studies and interventions are needed to establish effective management strategies.
Acupressure, a non-invasive technique derived from traditional Chinese medicine, has been explored as a potential non-pharmacological approach for reducing fatigue across various domains, such as behavioral, emotional, sensory, and cognitive fatigue (Chang et al., 2024). Acupressure can be performed by patients themselves after appropriate training, rather than relying on a therapist. Self-administered acupressure is time-efficient, low-cost, and easy to learn. Several studies have investigated its use for managing insomnia disorder (Yeung et al., 2022), pain in patients with osteoarthritis (Guo et al., 2021; Yeung et al., 2024), cancer-related fatigue in breast cancer survivors (Zick et al., 2016), quality of life in patients with perennial allergic rhinitis (Li et al., 2023), and anxiety levels in prediabetic women (Haghighat et al., 2024). Recently, a pilot RCT demonstrated that self-acupressure is safe and feasible for preventing respiratory tract infections in patients with chronic kidney disease (CKD) (Liu et al., 2022) and for managing symptoms and improving quality of life in HD patients (Parker et al., 2024).
The rapid advancement of mobile health (mHealth) technologies has significantly enhanced both the accessibility and personalization of healthcare. Smartphone applications, in particular, have become valuable tools for promoting self-care and managing chronic conditions (Sockolow et al., 2021; Wang et al., 2021) through features such as personalized goal setting, timely reminders, social interaction, and supportive feedback (Yi et al., 2018). A systematic review indicated that app-based mHealth interventions can effectively reduce stress and enhance self-management among non-clinical and subclinical populations (Sîrbu & David, 2024). Moreover, app-based interventions demonstrate their superiority in reducing fatigue among HD patients. A previous randomized controlled trial demonstrated that a recreational therapy app significantly reduced fatigue levels compared to standard care (Alishahi et al., 2024). The app provided a variety of content, including music, comedy, exercise, and educational materials, to help patients manage various dimensions of fatigue.
Although previous studies have shown that acupressure can effectively reduce fatigue, most studies have relied on trained therapists to administer the treatment. This limits accessibility and long-term sustainability, particularly for those who need ongoing symptom management. Although growing interest in digital health solutions, few studies have explored the use of mobile applications to guide self-administered acupressure as a convenient, cost-effective, and scalable alternative. App-based platforms can empower patients by enabling consistent practice and offering immediate, guided instruction without the need for direct clinical supervision. This approach, combining traditional therapies with modern digital tools, may enhance patient self-management and improve fatigue-related outcomes. Therefore, the primary aim of this study is to evaluate the effectiveness of an app-based self-guided acupressure intervention in alleviating fatigue among patients undergoing hemodialysis. The secondary aims are to examine its effects on pruritus and sleep quality in the same population. The hypotheses of this study are:
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patients are
- •18 years old or over
- •are able to speak and understand Vietnamese,
- •receive hemodialysis at least three times a week for three months or longer
- •have a score equal to or greater than 4 on a numeric rating scale (NRS, 0-10)
- •has a smartphone or tablet
- •can provide written informed consent.
排除标准
- •The patients who have
- •advanced cancer
- •cognitive impairment
- •chronic obstructive pulmonary disease
- •severe edema
- •have already used or plan to use acupressure or acupuncture in the following 3 months
- •have soft tissue or vascular disease in their lower extremities
研究组 & 干预措施
App-based acupressure Group
The intervention group will use an app-based self-guided acupressure program to do the acupressure by themselves once daily for 4 weeks.
干预措施: app-based acupressure (Device)
Control group
Participants in the control group will receive usual care and no other intervention. After completing the 12-week study, they will be granted free access to the application.
结局指标
主要结局
Fatigue
时间窗: Fatigue will be assessed at the same time points for both groups (baseline (T1), 2 weeks during intervention (T2), immediately after the intervention (T3), 4 weeks follow-up after the intervention (T4), and 8 weeks follow-up after the intervention (T5)).
Fatigue will be measured by Post-dialysis fatigue (PDF) scale. This scale comprises 13 self-reported items rated on a five-point Likert scale, ranging from 1 (strongly agree) to 5 (not at all). The score will be reversed for analysis, and the total score is between 13 and 65, with higher scores indicating more severe fatigue.
次要结局
- Pruritus(Pruritus will be assessed at the same time points for both groups (baseline (T1), 2 weeks during intervention (T2), immediately after the intervention (T3), 4 weeks follow-up after the intervention (T4), and 8 weeks follow-up after the intervention (T5)))
- Sleep quality(Outcome will be assessed at the same time points for both groups (baseline (T1), 2 weeks during intervention (T2), immediately after the intervention (T3), 4 weeks follow-up after the intervention (T4), and 8 weeks follow-up after the intervention (T5)).)
研究者
NGUYEN THI THUY NGA
PhD student
Taipei Medical University
