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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kibrıs Aydin Üniversitesi

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Cyprus Aydin University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 19, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 2, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 8, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 14, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 10, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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