REFLEXOLOGY AND SLEEP HYGIENE IN HEMODIALYSIS TREATMENT (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

Keywords

Foot Reflexology; Sleep Hygiene; Sleep Quality; Hemodialysis; Nursing Care

Outcome Measures

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.

  Baseline and 8 weeks

Secondary Outcomes (1)

• Hemodialysis Comfort Scale II (HCS-II)

  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 Hygİene 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 Hygİene 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

• Cyprus Aydin University: collaborator
• Kibrıs Aydin Üniversitesi: lead

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)

• 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.

  PMID: 40786836 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

Kidney Failure, Chronic; Sleep Hygiene; Sleep Initiation and Maintenance Disorders

Interventions

Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; 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; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

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: PRINCIPAL 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: July 14, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CY (2)