Effect of Acupressure on Sleep Quality in Hemodialysis Patients: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Sleep Quality: This measure will assess the quality of sleep during the intervention period.
研究概览
简要总结
This study aimed to evaluate the effects of acupressure applied to patients receiving hemodialysis treatment on sleep quality.
详细描述
Chronic kidney disease (CKD) is a common chronic disease worldwide and in our country, significantly affecting individuals' quality of life in physical, social, and psychological aspects. CKD is defined as a chronic and progressive deterioration of the kidney's fluid-solute balance and metabolic-endocrine functions due to the persistent decline in glomerular filtration rate (GFR) (Ammirati et al., 2020; Kalantar-Zadeh et al., 2021). Patients with a GFR below 5-10 ml/min require Renal Replacement Therapy (RRT). RRT is defined as a treatment method that replaces the kidney's normal blood filtration function when the kidneys can no longer perform this role. In the early stages of CKD, RRT becomes necessary when the disease cannot be controlled with diet and medication. Renal replacement therapies include hemodialysis, peritoneal dialysis, and renal transplantation (Tolasa et al., 2017; Eminsoy, 2018).
In our country, hemodialysis is the most preferred renal replacement therapy method for CKD treatment. The goal of hemodialysis is to improve patients' quality of life while reducing mortality and morbidity rates. Hemodialysis is a process in which blood is drawn from the patient through a suitable vascular access due to kidney failure, passed through a dialyzer (filter) with a semi-permeable membrane using a dialysis machine, and returned to the patient after removing waste substances such as urea, creatinine, and phosphorus from the blood (Webster et al., 2017; Yılmaz et al., 2020). Although hemodialysis helps control CKD-related complications, the treatment's dependency on a machine and its associated side effects-such as insomnia, fatigue, and restless legs syndrome-can negatively affect patients' quality of life (Merlino et al., 2006; Al-Jahemodiyalizali et al., 2010; Eminsoy, 2018; Hintistan et al., 2018; Tuna et al., 2018; Turgay et al., 2020).
Insomnia is characterized by symptoms indicating poor sleep quality, including difficulty falling asleep, unintended night awakenings, not feeling rested in the morning, daytime drowsiness, and impaired daytime functioning. Studies have shown that insomnia is highly prevalent among hemodialysis patients, with 40-83% experiencing sleep disturbances. These studies have found that sleep quality is low in hemodialysis patients, negatively impacting their quality of life, increasing cognitive impairment and inattentiveness, reducing work efficiency, and leading to higher mortality rates (Merlino et al., 2006; Al-Jahemodiyalizali et al., 2010; Hintistan et al., 2018; Rehman et al., 2020; Yang et al., 2021). In a study by Yıldırım et al. on insomnia, nearly all hemodialysis patients reported sleep problems both the night before (95.5%) and the night after (93.6%) dialysis treatment (Yıldırım et al., 2008). The frequent occurrence of sleep disorders and, consequently, insomnia during the hemodialysis process can be attributed to CKD-related biochemical and metabolic changes, lifestyle factors, other side effects of hemodialysis (such as fatigue, itching, and restless legs syndrome), as well as psychosocial issues like depression and anxiety (Özkan & Taylan, 2020).
Research on the effectiveness and safety of complementary and integrative therapies in treating HD complications is gaining increasing attention from researchers both nationally and internationally (Çevik & Taşçı, 2017; Eroğlu & Gök Metin, 2021; Suandika et al., 2023; Yeşil, 2023). The literature highlights that, in addition to pharmacological treatments, the use of non-pharmacological therapies in dialysis patients reduces fatigue, improves quality of life, enhances patient comfort, and is gaining increasing interest (Yeşil, 2023; Pompey et al., 2019; Sabouhi et al., 2013; Saeed et al., 2018; Yeşil Bayülgen & Gün, 2022). Among non-pharmacological treatment methods, acupressure, relaxation exercises, massage, reiki, and yoga can be independently performed by nurses, whereas aromatherapy, music therapy, and reflexology require physician supervision according to regulations (T.C. Traditional and Complementary Medicine Applications, 2014). Acupressure, a method from Traditional Chinese Medicine, is a technique based on the doctrine of meridians and acupuncture points. Acupressure is a gentle, safe, and non-invasive intervention with no risk of bleeding (Liu et al., 2023). The broad contact surface, easily controlled frequency and duration, and flexible pressure during massage enable both healthcare professionals and patient families to apply the method independently (İlter & Ovayolu, 2022; Eroğlu & Gök Metin, 2021). Consequently, acupressure is frequently used as an adjunct therapy to alleviate HD complications. Several studies have reported the effectiveness and safety of acupressure in treating HD complications (Marthoenis et al., 2021; Sabouhi et al., 2013; Saeed et al., 2018; Yeşil Bayülgen & Gün, 2022; Winzeler & Ambühl, 2020).
There are no randomized controlled studies investigating the effect of acupressure on sleep quality in HD patients. To establish the impact of acupressure on HD patients, high-quality, randomized controlled studies with sufficient sample sizes are needed. By implementing acupressure in this study, independent nursing interventions will be supported, increasing nurses' awareness and contributions to their practice. Additionally, if our research findings are adopted as institutional policy by hospital administrations, they will serve as a guide for nurses' care practices.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
This study is single-blind, meaning that participants are unaware of whether they are in the intervention or control group, while care providers and investigators have access to this information.
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
- 否
入选标准
- •Informed Voluntary Consent Form/Written Consent Form signed by the patient
- •Able to read, write, speak and understand Turkish
- •Over 18 years of age
- •Receiving HD treatment for at least 6 months
- •Receiving HD treatment 3 times a week
- •Conscious, fully oriented and cooperative, and open to communication
- •No vision, hearing and perception problems
- •General condition good and comfortable (vital signs within normal limits)
排除标准
- •Patients who do not sign the Informed Consent Form/Written Consent Form
- •Those who cannot read, write or understand Turkish
- •Those who are under 18 years of age
- •Those who have received HD treatment for less than 6 months
- •Those who receive HD treatment twice a week
- •Those who are unconscious, have incomplete orientation and cooperation and are closed to communication
- •Those who have vision, hearing and perception problems
- •Those whose general condition is not good
- •Those who have a wound or amputation in the lower extremity, rheumatoid arthritis or limb fracture
- •Those who have any psychiatric disease
- •Those who have Hepatitis B and Hepatitis C
- •Those who use any of the complementary and integrated methods
研究组 & 干预措施
Acupressure Application Group
This group consists of patients who have received acupressure. Acupressure will be applied to hemodialysis patients within the first two hours of HD and three times a week for four weeks. This intervention is carried out to evaluate sleep quality.
干预措施: Acupressure application (Other)
Control Group
Routine nursing care will be applied to this group without acupressure. Additionally, measurements will be made regarding sleep quality.
结局指标
主要结局
Sleep Quality: This measure will assess the quality of sleep during the intervention period.
时间窗: It will be measured twice: the first test at the first meeting with the patient and the final test four weeks later.
The PSQI scale will be recorded to assess the individual's sleep quality, quantity, presence and severity of sleep disturbance.
次要结局
未报告次要终点
研究者
Didem Lafci
Asst. Prof. Dr.
Mersin University
