PainNCT07295626
Symptom Control and Physiological Effects of Reflexology Applied After Stroke
A study testing Reflexology Intervention Group in people with Pain and Stroke, run by Hakkari Universitesi at 1 site in Turkey (Türkiye).
Trial summary
This study is designed as a randomized controlled intervention with a pre-test-post-test design to evaluate the effect of reflexology on pain, physiological parameters, and sleep quality in stroke patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Stroke, Reflexology
- What is being tested?
- Reflexology Intervention Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Oct 2024to 1 Jun 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals over the age of 18,
- No diagnosis of any psychiatric illness or medication use,
- Hemiplegic stroke patients,
- Volunteering to participate in the study,
- According to the patient introduction form; patients describing hemiplegic shoulder pain and insomnia symptoms,
- No history of neurological or psychiatric disorders other than stroke,
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- No irritation or ulceration in the skin area where reflexology will be performed,
- No history of deep vein thrombosis,
- Able to speak and understand Turkish and able to read and write,
- Patients who voluntarily agree to participate in the study will be included.
Who cannot join
- Refusal to participate in the study,
- Tetraplegic and paraplegic patients,
- Patients with stroke due to malignant brain damage undergoing chemotherapy or radiotherapy
- Those with mental and psychiatric disorders,
- Those who have received professional massage therapy within the past month,
- Those with contraindications for foot massage and reflexology: patients with generalized edema, pacemakers, history of heart attack, active gout, history of deep vein thrombosis, history of gallbladder and kidney stones, acute infection, fever, fractures, or wounds will not be included in the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Sciences Van Training and Research Hospital
Van, Edremit, 65100
About this study
Official title: Effects of Reflexology Applied to Stroke Patients on Pain, Physiological Parameters and Sleep Quality: A Randomized Controlled Trial
This study is designed as a randomized controlled intervention with a pre-test-post-test design to evaluate the effect of reflexology on pain, physiological parameters, and sleep quality in stroke patients. The study will be conducted at the Physical Therapy and Rehabilitation Unit of Van Training and Research Hospital between October 2024 and June 2025.
Using a simple randomization method, patients will be assigned to either the control group or the reflexology intervention group, with an anticipated sample size of 35 patients per group. Data will be collected using the Personal Information Form, the Visual Analog Scale (VAS), the Richards-Campbell Sleep Scale (RCSS), and a physiological parameters recording form.
Read more
Patients in the intervention group will receive reflexology massage twice a week for six weeks, for a total of 12 sessions. Each session will last 30 minutes (15 minutes per foot), in addition to routine nursing care. Physiological parameters will be recorded before and after each reflexology session. The control group will receive routine nursing care only, and their physiological parameters will be monitored twice weekly using the same schedule. All scales and forms will be administered again at the end of the 6-week period.
The study aims to determine whether reflexology influences pain levels, physiological parameters, and sleep quality in stroke patients. Findings from this research may contribute to the evidence base regarding complementary interventions in post-stroke nursing care; however, no study results are yet available in this protocol record.
Read the detailed description
This study is designed as a randomized controlled experimental trial to evaluate the effects of reflexology applied to individuals who have experienced a stroke on pain levels, physiological parameters, and sleep quality. The study includes an intervention group and a control group and aims to examine the role of reflexology within a holistic nursing care approach.
The research will be conducted between October 2024 and June 2025 at the Physical Therapy and Rehabilitation Unit of Van Training and Research Hospital. A single-blind method will be used, in which information about group assignment will be concealed from participants. Ethical committee approval has been obtained from a foundation university, and institutional approval has been received from the hospital where the study will take place.
Using a simple randomization method, patients will be assigned to either the reflexology group or the control group, with an anticipated sample size of 35 participants in each group. Data will be collected using the Personal Information Form, the Visual Analog Scale (VAS), the Richards-Campbell Sleep Scale (RCSS), and a physiological parameters recording form.
Participants in the intervention group will receive reflexology massage twice a week for six weeks, for a total of 12 sessions, each lasting 30 minutes (15 minutes per foot), in addition to routine nursing care. Physiological parameters will be recorded before and after each reflexology session. Participants in the control group will receive routine nursing care only, and their physiological parameters will be monitored twice weekly following the same schedule. All forms and scales will be administered again at the end of the sixth week.
This study aims to determine whether reflexology has an effect on pain, physiological parameters, and sleep quality in individuals who have experienced a stroke. The findings of the study will contribute to the evidence base regarding complementary practices used in nursing care; however, no study results are reported in this protocol record.
- Conditions
- Pain, Stroke, Reflexology, Nursing, Sleep Quality, Physiological Parameter
- Being tested
- Reflexology Intervention Group
- Keywords
- pain, stroke, reflexology, nursing, sleep quality, Physiological Parameter
- Medical subject headings
- Pain, Stroke, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reflexology Intervention GroupOther
This arm receives routine nursing care along with reflexology massage. Reflexology is applied twice a week for six weeks, with each session lasting 30 minutes (15 minutes per foot). The intervention aims to evaluate its effects on pain, physiological parameters, and sleep quality in stroke patients.
| Study group | Role | What they receive |
|---|---|---|
| Control Group - Routine Care | No intervention | This arm receives routine nursing care only, without reflexology massage. Physiological parameters, pain, and sleep quality are monitored twice weekly for six weeks, but no additional interventions are applied. This group serves as a comparison to evaluate the effects of reflexology. |
| Reflexology Intervention Group | Experimental | This arm receives routine nursing care along with reflexology massage. Reflexology is applied twice a week for six weeks, with each session lasting 30 minutes (15 minutes per foot). The intervention aims to evaluate its effects on pain, physiological parameters, and sleep quality in stroke patients. Receives: Other: Reflexology Intervention Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity
Visual Analog Scale Pain intensity will be measured using the Visual Analog Scale, a 10-cm scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst possible pain, with higher scores reflecting greater pain intensity. VAS scores will also be classified as follows: 0 = no pain; 1-2 = very mild pain; 3-4 = mild pain; 5-6 = moderate pain; 7-8 = severe pain; 9-10 = very severe pain. This measure will be used to evaluate the effect of the reflexology intervention on pain levels in stroke patients, assessed at baseline and at the end of Week 6.
Measured: Baseline and at the end of week 6.
Secondary outcomes (5)
Sleep Quality
Richards Campbell Sleep Scale On the scale, where each sleep statement is scored from 0 to 100, "0" corresponds to the worst situation for each statement, and "100" corresponds to the best situation. As the score on the scale increases, sleep quality improves.
Measured: Baseline and at the end of week 6.
Systolic Blood Pressure
Systolic blood pressure will be measured in millimeters of mercury (mmHg) to evaluate changes associated with the reflexology intervention in stroke patients.
Measured: Before and after each reflexology session, twice weekly for 6 weeks.
Diastolic Blood Pressure
Diastolic blood pressure will be measured in millimeters of mercury (mmHg) to assess physiological response to the reflexology intervention.
Measured: Before and after each session, twice weekly for 6 weeks.
Heart Rate
Heart rate will be measured in beats per minute (bpm) to evaluate autonomic responses associated with the reflexology intervention.
Measured: Before and after each session, twice weekly for 6 weeks.
Oxygen Saturation
Oxygen saturation will be measured using pulse oximetry and recorded as a percentage (%) to monitor potential changes associated with the reflexology intervention.
Measured: Before and after each session, twice weekly for 6 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2025
- Study start15 Oct 2024
- Primary completion15 Oct 2024
- Study completion1 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- This study was conducted using a randomized controlled intervention design. Participants were randomly assigned to the intervention and control groups. The intervention group received reflexology massage along with routine nursing care; the control group received only routine nursing care. During the intervention period, patients' pain levels, physiological parameters, and sleep quality were measured. Analyses were performed using appropriate statistical methods to evaluate differences between groups.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hakkari Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samet Koltaş, Hakkari Universitesi
- Investigators
- Samet KOLTAŞ, Principal investigator, Hakkari Universty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07295626
- Sponsor's protocol ID
- HU-SHMYO-SK-01
- Status last verified
- Dec 2025
- First submitted
- 23 Nov 2025
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: individual participant data will be shared with other researchers. Data will be anonymized to protect participant privacy, and access will be provided upon request under specified conditions.
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Reflexology Applied to Stroke Patients on Pain, Physiological Parameters and Sleep Quality: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07295626
- Acronym / sponsor ID
- HU-SHMYO-SK-01
- Conditions
- Pain, Stroke, Reflexology, Nursing, Sleep Quality, Physiological Parameter
- Keywords
- pain, stroke, reflexology, nursing, sleep quality, Physiological Parameter
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Hakkari UniversitesiUniversity, hospital or other
- Study start
- 15 Oct 2024 (actual)
- Primary completion
- 15 Oct 2024 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 19 Dec 2025 (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.
This study is designed as a randomized controlled intervention with a pre-test-post-test design to evaluate the effect of reflexology on pain, physiological parameters, and sleep quality in stroke patients. The study will be conducted at the Physical Therapy and Rehabilitation Unit of Van Training and Research Hospital between October 2024 and June 2025.
Using a simple randomization method, patients will be assigned to either the control group or the reflexology intervention group, with an anticipated sample size of 35 patients per group. Data will be collected using the Personal Information Form, the Visual Analog Scale (VAS), the Richards-Campbell Sleep Scale (RCSS), and a physiological parameters recording form.
Patients in the intervention group will receive reflexology massage twice a week for six weeks, for a total of 12 sessions. Each session will last 30 minutes (15 minutes per foot), in addition to routine nursing care. Physiological parameters will be recorded before and after each reflexology session. The control group will receive routine nursing care only, and their physiological parameters will be monitored twice weekly using the same schedule. All scales and forms will be administered again at the end of the 6-week period.
The study aims to determine whether reflexology influences pain levels, physiological parameters, and sleep quality in stroke patients. Findings from this research may contribute to the evidence base regarding complementary interventions in post-stroke nursing care; however, no study results are yet available in this protocol record.
Detailed description
This study is designed as a randomized controlled experimental trial to evaluate the effects of reflexology applied to individuals who have experienced a stroke on pain levels, physiological parameters, and sleep quality. The study includes an intervention group and a control group and aims to examine the role of reflexology within a holistic nursing care approach.
The research will be conducted between October 2024 and June 2025 at the Physical Therapy and Rehabilitation Unit of Van Training and Research Hospital. A single-blind method will be used, in which information about group assignment will be concealed from participants. Ethical committee approval has been obtained from a foundation university, and institutional approval has been received from the hospital where the study will take place.
Using a simple randomization method, patients will be assigned to either the reflexology group or the control group, with an anticipated sample size of 35 participants in each group. Data will be collected using the Personal Information Form, the Visual Analog Scale (VAS), the Richards-Campbell Sleep Scale (RCSS), and a physiological parameters recording form.
Participants in the intervention group will receive reflexology massage twice a week for six weeks, for a total of 12 sessions, each lasting 30 minutes (15 minutes per foot), in addition to routine nursing care. Physiological parameters will be recorded before and after each reflexology session. Participants in the control group will receive routine nursing care only, and their physiological parameters will be monitored twice weekly following the same schedule. All forms and scales will be administered again at the end of the sixth week.
This study aims to determine whether reflexology has an effect on pain, physiological parameters, and sleep quality in individuals who have experienced a stroke. The findings of the study will contribute to the evidence base regarding complementary practices used in nursing care; however, no study results are reported in this protocol record.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This study was conducted using a randomized controlled intervention design. Participants were randomly assigned to the intervention and control groups. The intervention group received reflexology massage along with routine nursing care; the control group received only routine nursing care. During the intervention period, patients' pain levels, physiological parameters, and sleep quality were measured. Analyses were performed using appropriate statistical methods to evaluate differences between groups.
| Arm | Type | Receives |
|---|---|---|
| Control Group - Routine Care | No intervention | –This arm receives routine nursing care only, without reflexology massage. Physiological parameters, pain, and sleep quality are monitored twice weekly for six weeks, but no additional interventions are applied. This group serves as a comparison to evaluate the effects of reflexology. |
| Reflexology Intervention Group | Experimental | Other: Reflexology Intervention GroupThis arm receives routine nursing care along with reflexology massage. Reflexology is applied twice a week for six weeks, with each session lasting 30 minutes (15 minutes per foot). The intervention aims to evaluate its effects on pain, physiological parameters, and sleep quality in stroke patients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Individuals over the age of 18,
- No diagnosis of any psychiatric illness or medication use,
- Hemiplegic stroke patients,
- Volunteering to participate in the study,
- According to the patient introduction form; patients describing hemiplegic shoulder pain and insomnia symptoms,
Key exclusion criteria (6 listed)
- Refusal to participate in the study,
- Tetraplegic and paraplegic patients,
- Patients with stroke due to malignant brain damage undergoing chemotherapy or radiotherapy
- Those with mental and psychiatric disorders,
- Those who have received professional massage therapy within the past month,
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 |
|---|---|---|
| Reflexology Intervention GroupThis arm receives routine nursing care along with reflexology massage. Reflexology is applied twice a week for six weeks, with each session lasting 30 minutes (15 minutes per foot). The intervention aims to evaluate its effects on pain, physiological parameters, and sleep quality in stroke patients. | Other | Reflexology Intervention Group |
Primary outcome
Pain Intensity
Time frame: Baseline and at the end of week 6.
Visual Analog Scale Pain intensity will be measured using the Visual Analog Scale, a 10-cm scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst possible pain, with higher scores reflecting greater pain intensity. VAS scores will also be classified as follows: 0 = no pain; 1-2 = very mild pain; 3-4 = mild pain; 5-6 = moderate pain; 7-8 = severe pain; 9-10 = very severe pain. This measure will be used to evaluate the effect of the reflexology intervention on pain levels in stroke patients, assessed at baseline and at the end of Week 6.
5 secondary outcomes
Sleep Quality
Time frame: Baseline and at the end of week 6.
Systolic Blood Pressure
Time frame: Before and after each reflexology session, twice weekly for 6 weeks.
Diastolic Blood Pressure
Time frame: Before and after each session, twice weekly for 6 weeks.
Heart Rate
Time frame: Before and after each session, twice weekly for 6 weeks.
Oxygen Saturation
Time frame: Before and after each session, twice weekly for 6 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 19 Dec 2025.
- University of Health Sciences Van Training and Research HospitalLink provided by the sponsor.
- Hasan Kalyoncu University Faculty of Health SciencesLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. individual participant data will be shared with other researchers. Data will be anonymized to protect participant privacy, and access will be provided upon request under specified conditions.
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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.
Samet KOLTAŞ principal investigator
Hakkari Universty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reflexology Intervention Group in people with Pain and Stroke, run by Hakkari Universitesi at 1 site in Turkey (Türkiye).
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 10 inclusion and 6 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 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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?
Pain Intensity (time frame: Baseline and at the end of week 6.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Dec 2025.