End Stage Kidney Disease (ESRD)NCT07253831
Hand Reflexology for Fatigue and Anxiety in Hemodialysis Patients
A study testing Hand Reflexology Massage and Standard in people with End Stage Kidney Disease (ESRD) and Hemodialysis, run by Kufa University at 1 site in Iraq.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Kidney Disease (ESRD), Hemodialysis, Anxiety
- What is being tested?
- Hand Reflexology Massage and Standard
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteIraq
- Study dates
- 1 Nov 2025to 5 Feb 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- End Stage Kidney Disease (ESRD), Hemodialysis, Anxiety, Fatigue, Reflexology
- Being tested
- Hand Reflexology Massage, Standard
- 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
- Medical subject headings
- Kidney Failure, Chronic, Anxiety Disorders, Fatigue, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hand Reflexology MassageProcedure or surgery
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.
StandardProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Standard |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2025
- Study start1 Nov 2025
- Primary completion5 Feb 2026
- Study completion5 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for End Stage Kidney Disease (ESRD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kufa University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sabah Kareem Jabbar Alwan, Kufa University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07253831
- Sponsor's protocol ID
- SKJ-HRM-HD-2025
- Status last verified
- Mar 2026
- First submitted
- 19 Nov 2025
- Last updated
- 13 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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
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.
PubMed 38001461Rejeh 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.
PubMed 32908698