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.

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:

Design: Two-arm, parallel-group, single-center (two affiliated units), assessor-blinded randomized controlled trial Allocation: 1:1 randomization via computer-generated sequence Sample Size: 70 participants (35 per group) Setting: Fatemah Al-Zahraa and Al-Hayat Hemodialysis Centers, Al-Diwaniyah, Iraq

Intervention:

Experimental Group: Receives hand reflexology massage (HRM) in addition to usual care.

Dose: Eight sessions over four weeks (twice weekly) Duration: 21 minutes per session, delivered during hemodialysis Technique: Standardized protocol applying gentle pressure to reflex points on both hands, using odorless Johnson's baby oil Delivery: Administered by the principal investigator using a digital timer-guided interface on a tablet Control Group: Receives usual care only (no additional touch, attention, or sham procedure)

Outcome Measures:

Primary Outcomes:

Change in fatigue severity from baseline to post-intervention (T2), measured by the FACIT-Fatigue Scale Change in anxiety severity from baseline to post-intervention (T2), measured by the Arabic version of the Beck Anxiety Inventory (BAI)

Assessment Time Points:

T0: Baseline (before first session) T1: After 4 sessions (2 weeks) T2: After 8 sessions (4 weeks) Secondary Analysis: Moderation effects of age, gender, education, dialysis vintage, and financial status on outcome changes

Eligibility Criteria:

Inclusion: Adults (≥18 years) on maintenance hemodialysis for ≥3 months; able to communicate; provide informed consent Exclusion: Severe cognitive impairment; active hand infection or trauma; history of psychiatric hospitalization; participation in other interventions

Data Management:

Electronic data collection via KoboToolbox on tablets No missing data (complete case analysis) Statistical analysis: Intention-to-treat; non-parametric tests for within-group changes (Friedman, Wilcoxon); between-group comparisons using Mann-Whitney U or t-tests as appropriate

Significance:

This study provides evidence on a safe, low-cost, culturally acceptable nursing intervention that can be integrated into routine hemodialysis care in Iraq and similar settings, potentially improving quality of life without pharmacological side effects.

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

The study does not plan to share Individual Participant Data (IPD) due to the sensitive nature of the data collected, which includes personal health information from a vulnerable patient population undergoing hemodialysis in Iraq. The informed consent obtained from participants did not include provisions for data sharing beyond the research team, and the ethical approval from the University of Kufa's Medical Ethical Committee restricts the dissemination of raw data to protect participant confidentiality and comply with local data protection regulations. Additionally, the small sample size and the specific cultural context of the study limit the generalizability of the data, making it unsuitable for secondary analysis by external researchers.

From the first intervention session until the completion of the 8th session (4 weeks).

Adverse events were monitored by the researcher during and immediately after each HRM session through clinical observation and participant self-reporting.

As a pragmatic trial, it lacked an active attention control (e.g., sham massage). The single-center setting and the sample size may limit the generalizability of the findings.