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Completed

NCT Number: NCT07518628

REFLEXOLOGY AND SLEEP HYGIENE 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.

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Key information

Conditions

End-stage Renal Disease Behavior Chronic Disease Disease Attributes Dyssomnias Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Health Behavior Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Mental Disorders Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Sleep Disorders, Intrinsic Sleep Hygiene Sleep Initiation and Maintenance Disorders Sleep Wake Disorders Urogenital Diseases Urologic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nephrology Department +Nicosia State Hospital, Nicosia, Cyprus

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Kibrıs Aydin Üniversitesi

Other

Collaborators

  • Cyprus Aydin University

Registry information

Official study title

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

Acronym: HD

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Apr 8, 2026
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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