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CompletedNCT07518628HDUpdated Oct 13, 2026

REFLEXOLOGY AND SLEEP HYGIENE IN HEMODIALYSIS TREATMENT (HD)

An interventional study of Reflexology in End-Stage Renal Disease, sponsored by Kibrıs Aydin Üniversitesi. Completed at 2 sites in Cyprus. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-13.

Sponsored by Kibrıs Aydin Üniversitesi · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 1 year 6 months after the study started (first participant enrolled Sep 2024, registered Mar 2026).
Updated Oct 13, 20261 site added1 site removedGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

Sleep problems are common in people undergoing dialysis treatment due to kidney failure. Methods other than medication can be used to improve this condition. For example, reflexology, a foot massage technique, and sleep training can be helpful.

This study investigated the effects of reflexology and sleep training on sleep quality and comfort in dialysis patients in Cyprus.

The results showed that both reflexology and sleep training improved patients' sleep and overall comfort. However, reflexology was found to be more effective than the other methods.

Objective:

To improve sleep quality and comfort in dialysis patients.

Method:

Reflexology (foot massage) and sleep training were applied.

Findings:

Both methods improved sleep and comfort.

Conclusion:

Reflexology was found to be more effective than sleep training.

Read the detailed description

Study Design:

This study was designed as a pre-test-post-test controlled experimental clinical trial.

Objective:

To evaluate the effects of reflexology and sleep hygiene training on sleep quality and comfort level in patients undergoing hemodialysis treatment.

Participants:

Individuals receiving hemodialysis treatment were included in the study.

Interventions:

Reflexology group: Patients received foot reflexology at regular intervals. Sleep hygiene training group: Patients received regular training to improve their sleep habits.

Control group: Routine care was provided.

02

Conditions studied

  • End-Stage Renal Disease

Keywords

  • Foot Reflexology
  • Sleep Hygiene
  • Sleep Quality
  • Hemodialysis
  • Nursing Care
03

In context

Kidney Failure, Chronic

2,108 studies on the registry are indexed under Kidney Failure, Chronic; 273 are open to participants now.

This study's enrollment of 60 is close to the median of 57 across 1,569 interventional studies indexed under Kidney Failure, Chronic.

Browse Kidney Failure, Chronic studies →

Lead sponsor

Kibrıs Aydin Üniversitesi is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients undergoing hemodialysis for at least 6 months
  • Voluntary participation in the study
  • Aged between 18 and 65 years
  • No communication problems
  • No active infectious disease

Exclusion criteria

Exclusion Criteria

  • Presence of an open foot ulcer
  • Suspected fracture or burn in the foot area
  • Thrombocytopenia
  • Diagnosed deep vein thrombosis 5.Diagnosed peripheral neuropathy
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    Arm 1: Reflexology Group

    Participant in this group receive reflexology intervention in addition to routine hemodialysis care.Reflexology is applied regularly during the study period according to a standardized protocol.

    Behavioral: Reflexology

  • Experimental
    Arm 2: Sleep Hygİene Training Group

    Participants in this group receive sleep hygiene education along with routine care.The education includes structured information and recommendation aimed at improving sleep habits and sleep quality.

    Behavioral: Reflexology

  • Other
    Arm 3: Control Group

    Participants received routine hemodialysis care without additional intervention.

    Behavioral: Reflexology

Interventions

  • BehavioralReflexology

    Reflexology in this study is a structured, standardized foot reflexology protocol specifically designed for hemodialysis patients. Unlike general massage applications, this intervention focuses on defined reflex points on the feet that are theoretically associated with systemic effects, particularly relaxation and sleep regulation. The sessions were delivered twice weekly for 30 minutes over 8 weeks by a trained practitioner using a consistent technique and pressure protocol. This standardized duration, frequency, and protocol distinguish it from non-structured or general complementary massage practices used in other studies.

06

What researchers measure

Primary outcomes

  1. Pittsburgh Sleep Quality Index (PSQI).

    The Pittsburgh Sleep Quality Index (PSQI) was developed by Daniel J. Buysse et al. in 1989. The Turkish validity and reliability study of the scale was conducted by Mehmet Yavuz Ağargün et al. The PSQI is a widely used instrument that evaluates individuals' sleep quality and distinguishes between "good sleepers" and "poor sleepers." The PSQI consists of 18 items and seven components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. Each component is scored on a 0-3 scale, and the sum of the component scores yields a total score ranging from 0 to 21. A total score of ≥5 indicates poor sleep quality.

    Time frame: Baseline and 8 weeks

Secondary outcomes

  1. Hemodialysis Comfort Scale II (HCS-II)

    The Hemodialysis Comfort Scale II (HCS-II) was developed by Sultan Koşar Şahin and Sema Pakyüz. It is a valid and reliable instrument used to assess the comfort level of patients who have been receiving hemodialysis treatment for at least three months. The scale consists of 26 items and six subdimensions and is structured as a 5-point Likert-type scale. Higher total scores indicate a higher level of comfort, whereas lower scores indicate lower comfort levels.

    Time frame: Baseline and 8 weeks

07

Study locations

2 sites
  • Nephrology Department +Nicosia State Hospital
    Nicosia, Cyprus 1010, Cyprus
  • Nephrology Department +Nicosia State Hospital+Cyprus
    Nicosia, 1010, Cyprus
08

References and documents

Publications

  • Rajabi R, Akhlaghi F, Asadi N, Zamani Babgohari F, Arabpoor F. The Effect of Foot Reflexology Massage on Fatigue and Sleep Quality in Hemodialysis Patients. SAGE Open Nurs. 2025 Aug 6;11:23779608251364099. doi: 10.1177/23779608251364099. eCollection 2025 Jan-Dec. PubMed 40786836 ↗

Individual participant data

Plan to share: No — Individual participant data will not be shared to protect participant privacy and confidentiality. Only aggregated results will be published.

09

Updates

1 registry update since Sep 25, 2026
Sites
1 site added, 1 site removed
Show site
  • Nephrology Department +Nicosia State Hospital · Nicosia, Cyprus
Show 1 removed
  • Nephrology Department +Nicosia State Hospital · Nicosia, Cyprus
Oct 13, 2026
Show all 1 update
  1. Oct 13, 2026
    1 site added, 1 site removed
    Show site
    • Nephrology Department +Nicosia State Hospital · Nicosia, Cyprus
    Show 1 removed
    • Nephrology Department +Nicosia State Hospital · Nicosia, Cyprus
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07518628
Lead sponsor
Kibrıs Aydin Üniversitesi
Collaborators
Cyprus Aydin University
Responsible party
Ulfet Kral (Postgraduate, Kibrıs Aydin Üniversitesi) — Principal investigator
First posted
Apr 8, 2026
Start date
Sep 1, 2024
Primary completion
Dec 1, 2024
Completion
Mar 1, 2025
Last update
Oct 13, 2026

Study contacts

LALE A BÜYÜKGÖNENÇ, MD
study director · Cprus Aydın University
Ulfet K KRAL, PhD
principal investigator · KIBRIS AYDIN ÜNİVERSİTESİ

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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