The Effect of Hand Reflexology Massage on Fatigue and Anxiety Levels Among Patients Receiving Maintenance Hemodialysis: A Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Change in Fatigue Levels as Measured by the Arabic FACIT-Fatigue Scale (FACIT-F)
研究概览
简要总结
This randomized controlled trial evaluates the efficacy of hand reflexology massage (HRM) in reducing fatigue and anxiety among adult patients receiving maintenance hemodialysis. Participants are randomly assigned to either an HRM intervention group or a usual care control group. The HRM group receives eight 21-minute sessions of hand reflexology during routine hemodialysis visits over four weeks, while the control group continues with standard care only. Outcomes are measured using validated scales at baseline, mid-intervention (after 4 sessions), and post-intervention (after 8 sessions). This non-pharmacological, nurse-deliverable intervention is designed to be culturally appropriate, feasible in resource-limited settings, and respectful of patient comfort during dialysis.
详细描述
Background:
Fatigue and anxiety are highly prevalent and distressing symptoms among patients on maintenance hemodialysis, yet pharmacological management carries risks and limitations. Non-invasive, integrative therapies such as hand reflexology offer a promising alternative, particularly in settings like Iraq where nursing-led interventions can enhance holistic care without increasing medication burden.
Objective:
To determine whether hand reflexology massage significantly reduces fatigue and anxiety levels compared to usual care in adult hemodialysis patients, and to examine whether sociodemographic factors moderate treatment response.
Study Design:
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
- Double (Participant, Investigator)
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
- •Adults aged 18 years and older.
- •Diagnosed with End-Stage Renal Disease (ESRD) and undergoing maintenance hemodialysis for at least three months.
- •Receiving hemodialysis treatment two or three times per week.
- •Fully alert, conscious, and able to communicate clearly.
- •Able to understand the Arabic language.
- •Willing to participate in the study and provide informed consent.
排除标准
- •Presence of ulcers, wounds, burns, infections, or skin diseases on the hands or forearms.
- •Deformities, fractures, or orthopedic disorders affecting the hands or upper limbs.
- •Peripheral neuropathy, vascular problems, or Raynaud's phenomenon in the hands.
- •Diagnosis of major psychiatric disorders (e.g., psychosis, bipolar disorder, generalized anxiety disorder).
- •Active systemic diseases that contribute to fatigue or anxiety (e.g., cancer, heart failure, lupus).
- •Use of sedatives, anxiolytics, or sleeping pills within 48-72 hours prior to data collection.
- •Current use of complementary or alternative therapies aimed at managing anxiety or fatigue.
- •History of drug or alcohol abuse.
- •Presence of implanted cardiac devices (e.g., pacemaker, implantable cardioverter defibrillator).
- •Hemodynamic instability or unstable vital signs during hemodialysis sessions.
- •Missing more than two scheduled intervention sessions during the study period.
研究组 & 干预措施
Hand Reflexology Massage
Participants in this group will receive standard hemodialysis care plus eight sessions of hand reflexology massage over four weeks. Each session, lasting 21 minutes, will be conducted twice a week during their dialysis treatment and will focus on specific reflex points-including the solar plexus, diaphragm line, adrenal glands, kidneys, pituitary gland, and heart point (on the left hand)-to promote relaxation and support symptom management for fatigue and anxiety.
干预措施: Hand Reflexology Massage (Procedure)
Standard Care
Participants in this group will receive routine hemodialysis care only, without any additional hand reflexology massage. This includes standard nursing care, monitoring, and medical management as per the center's protocol. This group serves as a control to compare against the intervention group receiving hand reflexology.
干预措施: Standard (Procedure)
结局指标
主要结局
Change in Fatigue Levels as Measured by the Arabic FACIT-Fatigue Scale (FACIT-F)
时间窗: 4 weeks
The Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-F, Version 4) is a validated 13-item questionnaire used to assess fatigue severity and its impact on quality of life over the past week. Each item is scored on a 5-point Likert scale (0 = "Not at all" to 4 = "Very much"). After reverse-scoring specific items, the total score ranges from 0 to 52, with higher scores indicating lower levels of fatigue. This measure will be administered to participants in both the intervention and control groups at three time points to evaluate the effect of Hand Reflexology Massage.
Change in Anxiety Levels as Measured by the Arabic Beck Anxiety Inventory (Ar-BAI)
时间窗: 4 weeks
The Arabic version of the Beck Anxiety Inventory (Ar-BAI) is a 21-item self-report scale used to measure the severity of anxiety symptoms experienced in the past week. Each item is scored from 0 ("Not at all") to 3 ("Severely-it bothered me a lot"), resulting in a total score ranging from 0 to 63. Higher scores indicate greater anxiety severity. This measure will be used to compare changes in anxiety between the two study groups across the same three assessment periods.
次要结局
未报告次要终点
研究者
Sabah Kareem Jabbar Alwan
Master's Student / Principal Investigator
Kufa University