Hand Reflexology for Fatigue and Anxiety in Hemodialysis Patients

NCT07253831 | Completed Results

• 1 other identifier: SKJ-HRM-HD-2025
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety; Fatigue; Reflexology; End Stage Kidney Disease (ESRD); Hemodialysis

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

Outcome Measures

Primary Outcomes (2)

• Change in Fatigue Levels as Measured by the Arabic FACIT-Fatigue Scale (FACIT-F)

  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)

  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

Study Arms (2)

Hand Reflexology Massage

EXPERIMENTAL

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

Standard Care

ACTIVE COMPARATOR

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

Interventions

Standard PROCEDURE

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.

Standard Care

Hand Reflexology Massage PROCEDURE

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.

Hand Reflexology Massage

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kufa University: lead

Study Sites (1)

Sabah Kareem Alshibli

Al Qādisīyah, Aldiwanyah, 58001, Iraq

Location

Related Publications (3)

• Heidari, F., Rejeh, N., Heravi-Karimooi, M., Tadrisi, S. D., & Vaismoradi, M. (2017). Effect of short-term hand reflexology on anxiety in patients before coronary angiography: A randomized placebo controlled trial. European Journal of Integrative Medicine, 16, 1-7. https://doi.org/10.1016/j.eujim.2017.09.010

  RESULT

• Ali EA, Awad WHA, Khedr MA, Rabie EAEGA. Effect of hand reflexology in ameliorating anxiety, pain, and fatigue among patients undergoing coronary angiography. BMC Complement Med Ther. 2023 Nov 24;23(1):425. doi: 10.1186/s12906-023-04256-6.

  PMID: 38001461 RESULT

• Rejeh N, Tadrisi SD, Yazdani S, Saatchi K, Vaismoradi M. The Effect of Hand Reflexology Massage on Pain and Fatigue in Patients after Coronary Angiography: A Randomized Controlled Clinical Trial. Nurs Res Pract. 2020 Aug 29;2020:8386167. doi: 10.1155/2020/8386167. eCollection 2020.

  PMID: 32908698 RESULT

MeSH Terms

Conditions

Kidney Failure, Chronic; Anxiety Disorders; Fatigue; Renal Insufficiency

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Mental Disorders; Signs and Symptoms

Limitations and Caveats

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.

Results Point of Contact

• Title: Mr. Sabah Kareem Alshibli
• Organization: Kufa University / College of Nursing

sabahk.alshibli@student.uokufa.edu.iq

780 211 7240

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master's Student / Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: November 28, 2025
• Study Start: November 1, 2025
• Primary Completion: February 5, 2026
• Study Completion: February 5, 2026
• Last Updated: May 13, 2026
• Results First Posted: May 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)