Effect of Hand Reflexology Massage on Fatigue and Anxiety Among Patients Undergoing Hemodialysis

NCT07253831 | Not Yet Recruiting

• 1 other identifier: SKJ-HRM-HD-2025
• Study Type: interventional
• Target: 104
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this clinical trial is to learn if hand reflexology massage can help reduce fatigue and anxiety in adult patients undergoing hemodialysis treatment. The main questions it aims to answer are:

• What are the levels of fatigue and anxiety in hemodialysis patients?
• Is hand reflexology massage more effective than usual care in reducing fatigue and anxiety after eight sessions?
• Do these improvements last over time?
• Does a patient's age, gender, education level, how long they've been on dialysis, or their financial status affect how much they benefit from the massage? Researchers will compare patients who receive hand reflexology massage plus standard care to those who receive only standard care to see if the massage leads to greater reductions in fatigue and anxiety. Participants will:
• Be randomly assigned to one group that receives hand reflexology massage or another group that continues with routine care only
• Attend 8 short sessions (about 27 minutes each) of hand reflexology massage over four weeks, given during their regular dialysis visits
• Complete brief questionnaires about their fatigue and anxiety levels before the study starts, after the 4th session, and after the 8th session
• Continue their normal medical treatments throughout the study This study focuses on a safe, non-drug therapy that nurses can easily provide. Hand reflexology involves gentle pressure on specific points of the hands linked to stress relief and relaxation. It is chosen because it is practical during dialysis, avoids touching swollen or sensitive feet, and respects cultural preferences. The results could help improve the comfort and well-being of hemodialysis patients in Iraq and similar healthcare settings.

Conditions

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

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 approximately 27 minutes, will be conducted twice a week during their dialysis treatment and will focus on specific reflex points (solar plexus, diaphragm line, adrenal glands, kidneys, pituitary gland, and heart point on the left hand) to promote relaxation and reduce 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

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

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

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.
• Demonstrates measurable levels of fatigue as assessed by the FACIT-Fatigue Scale.
• Demonstrates measurable levels of anxiety as assessed by the Beck Anxiety Inventory (Ar-BAI).
• 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.
• Refusal or inability to complete the required reflexology sessions or study questionnaires.
• Missing more than two scheduled intervention sessions during the study period.

Sponsors & Collaborators

• Kufa University: lead

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

Central Study Contacts

Sabah kareem Al-Shibli

CONTACT

+9647802117240; sabahk.alshibli@student.uokufa.edu.iq

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: January 1, 2026
• Primary Completion (Estimated): September 15, 2026
• Study Completion (Estimated): November 15, 2026
• Last Updated: November 28, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share