Reflexology and Sleep Hygiene in Hemodialysis Patients (HD) (HD)

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: Hemodialysis; Chronic Kidney Disease; End-Stage Renal Disease
• Intervention / Treatment: Behavioral: Reflexology

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

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

3

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.
Experimental: Arm 2: Sleep Hygiene 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep Quality	Sleep Quality will be assessed Pittsburgh Sleep Quality Index - PSQI	Baseline and 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Comfort	Using the Hemodialysis Comfort Scale	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	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

• Sponsor: Ulfet Kral
• 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

General Publications

• Article with DOI Rajabi R, et al. Effect of foot reflexology massage on fatigue and sleep quality in hemodialysis patients. SAGE Open Nurs. 2025;11:23779608251364099. doi:10.1177/23779608251364099

Helpful Links

• The study was conducted per the principles of the declaration of Helsinki. Ethical approval for the study was obtained from the Cyprus Aydın University Ethics Committee and from the state hospitals affiliated with the Ministry of Health of Northern Cypru

Study record dates

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): April 15, 2026
• Last Update Submitted That Met QC Criteria: April 11, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Nursing; Reflexology; Comfort; Sleep Hygiene; Hemodialsis Patients
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Pathological Conditions, Signs and Symptoms; Behavior; Health Behavior; Kidney Failure, Chronic; Renal Insufficiency, Chronic; Sleep Hygiene; Therapeutics; Complementary Therapies; Physical Therapy Modalities; Rehabilitation; Musculoskeletal Manipulations
• 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