An interventional study of Hand Reflexology Massage and Standard in End Stage Kidney Disease (ESRD), Hemodialysis and Anxiety, sponsored by Kufa University. Completed at 1 site in Iraq. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-13.
Sponsored by Kufa University · Not applicable, Interventional, and Treatment
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.
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.
2,108 studies on the registry are indexed under Kidney Failure, Chronic; 273 are open to participants now.
This study's enrollment of 70 is above the median of 57 across 1,569 interventional studies indexed under Kidney Failure, Chronic.
Browse Kidney Failure, Chronic studies →Kufa University is the lead sponsor of 14 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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 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.
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.
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.
Time frame: 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.
Time frame: 4 weeks
| Milestone | Hand Reflexology Massage | Standard Care |
|---|---|---|
| Started | 35 | 35 |
| Completed | 35 | 35 |
| Not completed | 0 | 0 |
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.
| Points on FACIT-Fatigue Scale | Hand Reflexology Massage | Standard Care |
|---|---|---|
| Baseline (T0) | 24.4 ± 10.1 | 21.7 ± 9.9 |
| Post-Intervention (T2) | 29.5 ± 9.5 | 21.2 ± 9.9 |
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.
| Points on Ar-BAI | Hand Reflexology Massage | Standard Care |
|---|---|---|
| Baseline (T0) | 20.7 ± 10.1 | 23.6 ± 12.2 |
| Post-Intervention (T2) | 12.8 ± 9.5 | 22.9 ± 11.8 |
Collected over From the first intervention session until the completion of the 8th session (4 weeks).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Hand Reflexology Massage | 0/35 (0%) | 0/35 (0%) | 0/35 (0%) |
| Standard Care | 0/35 (0%) | 0/35 (0%) | 0/35 (0%) |
| Age, Categorical(Participants) | Hand Reflexology Massage | Standard Care | Total |
|---|---|---|---|
| <=18 years | 1 | 1 | 2 |
| Between 18 and 65 years | 33 | 32 | 65 |
| >=65 years | 1 | 2 | 3 |
| Sex: Female, Male(Participants) | Hand Reflexology Massage | Standard Care | Total |
|---|---|---|---|
| Female | 10 | 12 | 22 |
| Male | 25 | 23 | 48 |
| Race and Ethnicity Not Collected(Participants) | Hand Reflexology Massage | Standard Care | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| FACIT-Fatigue Score at Baseline(Points on FACIT-Fatigue Scale) | Hand Reflexology Massage | Standard Care | Total |
|---|---|---|---|
| Mean | 24.4 ± 10.1 | 21.7 ± 9.9 | 23.1 ± 10.1 |
| Beck Anxiety Inventory Score at Baseline Measure Type(Points on Beck Anxiety Inventory) | Hand Reflexology Massage | Standard Care | Total |
|---|---|---|---|
| Mean | 20.7 ± 10.1 | 23.6 ± 12.2 | 22.2 ± 11.3 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: 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.
This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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