Symptom Control and Physiological Effects of Reflexology Applied After Stroke

NCT07295626 | Completed DMC

• 1 other identifier: HU-SHMYO-SK-01
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Reflexology; Nursing; Sleep Quality; Physiological Parameter; Pain; Stroke

Keywords

pain; stroke; reflexology; nursing; sleep quality; Physiological Parameter

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and at the end of week 6.

Secondary Outcomes (5)

• Sleep Quality

  Baseline and at the end of week 6.

• Systolic Blood Pressure

  Before and after each reflexology session, twice weekly for 6 weeks.

• Diastolic Blood Pressure

  Before and after each session, twice weekly for 6 weeks.

• Heart Rate

  Before and after each session, twice weekly for 6 weeks.

• Oxygen Saturation

  Before and after each session, twice weekly for 6 weeks.

Study Arms (2)

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.

Other: Reflexology Intervention Group

Interventions

Reflexology Intervention Group OTHER

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.

Reflexology Intervention Group

Eligibility Criteria

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

You may qualify if:

• 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,
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hakkari Universitesi: lead

Study Sites (1)

University of Health Sciences Van Training and Research Hospital

Van, Edremit, 65100, Turkey (Türkiye)

Location

Related Links

• University of Health Sciences Van Training and Research Hospital
• Hasan Kalyoncu University Faculty of Health Sciences

MeSH Terms

Conditions

Pain; Stroke; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Mental Disorders

Study Officials

• Samet KOLTAŞ

  Hakkari Universty

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: LECTURER

Model Details: 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.

Study Record Dates

• First Submitted: November 23, 2025
• First Posted: December 19, 2025
• Study Start: October 15, 2024
• Primary Completion: October 15, 2024
• Study Completion: June 1, 2025
• Last Updated: December 19, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Time Frame: Individual participant data will be made available beginning 6 months after study completion and will remain accessible for a period of 5 years.
• Access Criteria: Access to the de-identified individual participant data will be granted to qualified researchers who provide a methodologically sound research proposal and obtain ethics committee approval. Requests must include a brief study plan and justification for the use of the data. Data will be shared through secure institutional channels upon approval by the principal investigator and the hosting institution.

Locations

TU (1)