End-Stage Renal DiseaseHDNCT07518628
REFLEXOLOGY AND SLEEP HYGIENE IN HEMODIALYSIS TREATMENT (HD)
A study testing Reflexology in people with End-Stage Renal Disease, run by Kibrıs Aydin Üniversitesi at 2 sites in Cyprus.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- End-Stage Renal Disease
- What is being tested?
- Reflexology
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesCyprus
- Study dates
- 1 Sep 2024to 1 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Presence of an open foot ulcer
- Suspected fracture or burn in the foot area
- Thrombocytopenia
- Diagnosed deep vein thrombosis 5.Diagnosed peripheral neuropathy
Trial locations and contacts
2 sites in 1 country.
Cyprus2 sites
Nephrology Department +Nicosia State Hospital
Nicosia, Cyprus, 1010
Nephrology Department +Nicosia State Hospital+Cyprus
Nicosia, 1010
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- End-Stage Renal Disease
- Being tested
- Reflexology
- Keywords
- Foot Reflexology, Sleep Hygiene, Sleep Quality, Hemodialysis, Nursing Care
- Medical subject headings
- Kidney Failure, Chronic, Sleep Hygiene, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReflexologyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Reflexology |
| Arm 3: Control Group | Other | Participants received routine hemodialysis care without additional intervention. Receives: Behavioral: Reflexology |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 8 weeks
Secondary outcomes (1)
Hemodialysis Comfort Scale II (HCS-II)
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.
Measured: Baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2026
- Study start1 Sep 2024
- Primary completion1 Dec 2024
- Study completion1 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for End-Stage Renal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kibrıs Aydin Üniversitesi
- Sponsor type
- University, hospital or other
- Collaborators
- Cyprus Aydin University
- Responsible party
- Principal investigator, Ulfet Kral, Kibrıs Aydin Üniversitesi
- Investigators
- LALE A BÜYÜKGÖNENÇ, MD, Study director, Cprus Aydın UniversityUlfet K KRAL, PhD, Principal investigator, KIBRIS AYDIN ÜNİVERSİTESİ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07518628
- Sponsor's protocol ID
- CAU-ULFET-02
- Acronym
- HD
- Status last verified
- Oct 2026
- First submitted
- 19 Mar 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared to protect participant privacy and confidentiality. Only aggregated results will be published.
Publications
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.
PubMed 40786836
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE EFFECT OF REFLEXOLOGY AND SLEEP HYGIENE EDUCATION ON SLEEP QUALITY AND COMFORT LEVEL IN HEMODIALYSIS TREATMENT (HD)
- ClinicalTrials.gov ID
- NCT07518628
- Acronym / sponsor ID
- HD / CAU-ULFET-02
- Conditions
- End-Stage Renal Disease
- Keywords
- Foot Reflexology, Sleep Hygiene, Sleep Quality, Hemodialysis, Nursing Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Kibrıs Aydin ÜniversitesiUniversity, hospital or other
- Collaborators
- Cyprus Aydin University
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 8 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Reflexology Group | Experimental | Behavioral: ReflexologyParticipant 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. |
| Arm 2: Sleep Hygİene Training Group | Experimental | Behavioral: ReflexologyParticipants 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. |
| Arm 3: Control Group | Other | Behavioral: ReflexologyParticipants received routine hemodialysis care without additional intervention. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Presence of an open foot ulcer
- Suspected fracture or burn in the foot area
- Thrombocytopenia
- Diagnosed deep vein thrombosis 5.Diagnosed peripheral neuropathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ReflexologyReflexology 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. | Behavioural | Arm 1: Reflexology Group, Arm 2: Sleep Hygİene Training Group, Arm 3: Control Group |
Primary outcome
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.
1 secondary outcome
Hemodialysis Comfort Scale II (HCS-II)
Time frame: Baseline and 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Background: PubMed 40786836Rajabi 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.
- 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 CypruLink provided by the sponsor.
- Individual participant dataSharing planned: No. Individual participant data will not be shared to protect participant privacy and confidentiality. Only aggregated results will be published.
Related trials for End-Stage Renal Disease
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Recruiting
Guiding Optimal Blood Pressure Management in Peritoneal Dialysis Pilot Trial
End Stage Kidney Disease (ESKD), Hypertension (HTN)
RecruitingObservational study
Physical Impairments in Children With Chronic Renal Failure
Chronic Kidney Failure, Chronic Kidney Diseases
RecruitingPhase 1
A Study to Test the Safety of the Study Drug Fosmanogepix and How the Body Handles It in Adults With Severe Kidney Failure on Dialysis
End Stage Renal Disease on Dialysis, Adult
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
LALE A BÜYÜKGÖNENÇ, MD study director
Cprus Aydın University
Ulfet K KRAL, PhD principal investigator
KIBRIS AYDIN ÜNİVERSİTESİ
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reflexology in people with End-Stage Renal Disease, run by Kibrıs Aydin Üniversitesi at 2 sites in Cyprus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Cyprus. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pittsburgh Sleep Quality Index (PSQI). (time frame: Baseline and 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07518628, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.