Hand Reflexology for Fatigue and Anxiety in Hemodialysis Patients

April 21, 2026 updated by: Sabah Kareem Jabbar Alwan, Kufa University

The Effect of Hand Reflexology Massage on Fatigue and Anxiety Levels Among Patients Receiving Maintenance Hemodialysis: A Randomized Controlled Trial.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iraq
    • Aldiwanyah
      • Al Qādisīyah, Aldiwanyah, Iraq, 58001
        • Sabah Kareem Alshibli

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Procedure: Standard
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.
Experimental: 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.
Procedure: Hand 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Fatigue Levels as Measured by the Arabic FACIT-Fatigue Scale (FACIT-F)
Time Frame: 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.
4 weeks
Change in Anxiety Levels as Measured by the Arabic Beck Anxiety Inventory (Ar-BAI)
Time Frame: 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.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kufa University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2025

Primary Completion (Actual)

February 5, 2026

Study Completion (Actual)

February 5, 2026

Study Registration Dates

First Submitted

November 19, 2025

First Submitted That Met QC Criteria

November 19, 2025

First Posted (Actual)

November 28, 2025

Study Record Updates

Last Update Posted (Actual)

May 13, 2026

Last Update Submitted That Met QC Criteria

April 21, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SKJ-HRM-HD-2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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