REFLEXOLOGY AND SLEEP HYGIENE IN HEMODIALYSIS TREATMENT (HD) (HD)

July 10, 2026 updated by: Ulfet Kral, Kibrıs Aydin Üniversitesi

THE EFFECT OF REFLEXOLOGY AND SLEEP HYGIENE EDUCATION ON SLEEP QUALITY AND COMFORT LEVEL IN HEMODIALYSIS TREATMENT (HD)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Cyprus
      • Nicosia, Cyprus, 1010
        • Nephrology Department +Nicosia State Hospital+Cyprus
    • Cyprus
      • Nicosia, Cyprus, Cyprus, 1010
        • Nephrology Department +Nicosia State Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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.
Other: Arm 3: Control Group
Participants received routine hemodialysis care without additional intervention.
Behavioral: Reflexology
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.
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pittsburgh Sleep Quality Index (PSQI).
Time Frame: Baseline and 8 weeks
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.
Baseline and 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemodialysis Comfort Scale II (HCS-II)
Time Frame: Baseline and 8 weeks

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.
Baseline and 8 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Effect Of Reflexology And Sleep Hygiene Education Applied To Patients Undergoing Hemodialysis Treatment On Sleep Quality And Comfort Level
Time Frame: Participants in the control group received routine hemodialysis care without any additional intervention during the 8-week study period.
Control Group (Standard Care)
Participants in the control group received routine hemodialysis care without any additional intervention during the 8-week study period.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kibrıs Aydin Üniversitesi

Collaborators

Cyprus Aydin University

Investigators

  • Study Director: LALE A BÜYÜKGÖNENÇ, MD, Cprus Aydın University
  • Principal Investigator: Ulfet K KRAL, PhD, KIBRIS AYDIN ÜNİVERSİTESİ

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2024

Primary Completion (Actual)

December 1, 2025

Study Completion (Actual)

March 1, 2026

Study Registration Dates

First Submitted

March 19, 2026

First Submitted That Met QC Criteria

April 2, 2026

First Posted (Actual)

April 8, 2026

Study Record Updates

Last Update Posted (Actual)

July 14, 2026

Last Update Submitted That Met QC Criteria

July 10, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAU-ULFET-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared to protect participant privacy and confidentiality. Only aggregated results will be published.

Study Data/Documents

  1. Clinical Study Report
    Information identifier: The findings of this study sug

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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