Reflexology and Sleep Hygiene in Hemodialysis Patients (HD)

NCT07518628 | Completed DMC

• 1 other identifier: CAU-ULFET-02
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

End-Stage Renal Disease; Hemodialysis; Chronic Kidney Disease

Keywords

Reflexology; Sleep Hygiene; Comfort; Hemodialsis Patients; Nursing

Outcome Measures

Primary Outcomes (1)

• Sleep Quality

  Sleep Quality will be assessed Pittsburgh Sleep Quality Index - PSQI

  Baseline and 8 weeks

Secondary Outcomes (1)

• Patient Comfort

  Baseline and 8 weeks

Study Arms (3)

Arm 1: Reflexology Group

EXPERIMENTAL

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

Arm 2: Sleep Hygiene Training Group

EXPERIMENTAL

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

Arm 3: Control Group

OTHER

Participants received routine hemodialysis care without additional intervention.

Behavioral: Reflexology

Interventions

Reflexology BEHAVIORAL

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.

Arm 1: Reflexology Group; Arm 2: Sleep Hygiene Training Group; Arm 3: Control Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Ulfet Kral: lead
• Cyprus Aydin University: collaborator

Study Sites (2)

Nephrology Department +Nicosia State Hospital

Nicosia, Cyprus, 1010, Cyprus

Location

Nephrology Department +Nicosia State Hospital+Cyprus

Nicosia, 1010, Cyprus

Location

Related Publications (1)

• 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

  BACKGROUND

Related 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

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Kidney Failure, Chronic; Sleep Hygiene

Interventions

Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• LALE A BÜYÜKGÖNENÇ, MD

  Cprus Aydın University

  STUDY DIRECTOR

• Ulfet K KRAL, PhD

  KIBRIS AYDIN ÜNİVERSİTESİ

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Blinding was not possible in this study because participants could tell which intervention they received (reflexology, sleep hygiene training, or routine care). However, efforts were made to assess the outcomes in an objective and standardized way.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Postgraduate

Model Details: ABSTRACT Aim: This study aimed to investigate the effects of reflexology and sleep hygiene training on sleep quality and comfort in patients undergoing hemodialysis. Methods: This randomized controlled clinical trial included 60 hemodialysis patients, who were randomly assigned into three groups (20 each): reflexology, sleep hygiene training, and control. The reflexology group received reflexology twice weekly for 30 minutes over 8 weeks. The sleep hygiene group received weekly 20-minute training sessions for 8 weeks. The control group received routine care only. Sleep quality and comfort levels were assessed before and after the intervention. Results: Both reflexology and sleep hygiene training improved sleep quality and comfort levels compared to baseline. However, reflexology showed a greater improvement than sleep hygiene training and routine care. Conclusion: Reflexology is a more effective complementary intervention than sleep hygiene training in improving sleep qualit

Study Record Dates

• First Submitted: March 19, 2026
• First Posted: April 8, 2026
• Study Start: September 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: March 1, 2026
• Last Updated: April 15, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CY (2)