Anxiety, End Stage Kidney Disease (ESRD), Fatigue, Hemodialysis, Reflexology
Conditions
Keywords
Psychological distress, Quality of life, Renal failure, Randomized controlled trial, Nursing intervention, Complementary therapy, Hemodialysis, Fatigue, Anxiety, Non-pharmacological intervention, Hand Reflexology Massage, Reflexology
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREHand Reflexology Massage
The intervention is a standardized Hand Reflexology Massage (HRM) for adults on maintenance hemodialysis, applied twice weekly for four weeks during dialysis. Each 27-minute session follows a structured three-phase protocol: 7 minutes of preparatory relaxation, 18 minutes of targeted stimulation of key reflex points (Solar Plexus, Diaphragm, Adrenal/Kidney, Pituitary, and Heart on the left hand), and 2 minutes of concluding relaxation. Pressure is applied systematically using thumb or index finger. Male patients are treated by the principal investigator, females by a trained female co-researcher. This evidence-based, non-invasive therapy differs from general hand massage by focusing on validated reflex points, reducing fatigue and anxiety, and integrating safely into dialysis care.
PROCEDUREStandard
The control group receives standard care, which consists of routine hemodialysis treatment and standard nursing care as per the established protocols at Fatima Al-Zahraa and Al-Hayat Hemodialysis Centers. This includes monitoring vital signs, managing dialysis parameters, administering prescribed medications, providing general health education, and offering emotional support during the treatment sessions.
Sponsors
Kufa University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
This is a two-arm, assessor-blinded, randomized controlled trial. Participants are randomly assigned to either receive hand reflexology massage in addition to routine care or to continue with routine care alone.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Fatigue Levels as Measured by the Arabic FACIT-Fatigue Scale (FACIT-F) | 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) | 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. |
Countries
Iraq
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 2 Participants |
| Age, Categorical >=65 years | 2 Participants |
| Age, Categorical Between 18 and 65 years | 65 Participants |
| Beck Anxiety Inventory Score at Baseline Measure Type | 23.6 Points on Beck Anxiety Inventory STANDARD_DEVIATION 12.2 |
| FACIT-Fatigue Score at Baseline | 21.7 Points on FACIT-Fatigue Scale STANDARD_DEVIATION 9.9 |
| Race and Ethnicity Not Collected | 0 Participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 35 | 0 / 35 |
| other Total, other adverse events | 0 / 35 | 0 / 35 |
| serious Total, serious adverse events | 0 / 35 | 0 / 35 |
Outcome results
None listed