- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04756999
The Effect of Foot Reflexology Applied on Dialysis Patients
June 20, 2022 updated by: Gizem Göktuna, Dokuz Eylul University
The Effect of Foot Reflexology Applied to Dialysis Patients on Quality of Life and Symptom Control: A Randomized Clinical Trial
Reflexology is massage therapy used to maintain and improve health, as well as relieve some symptoms.
Foot reflexology, which is thought to have an effect on dialysis symptoms, will be applied to hemodialysis patients in 9 sessions.
In this study, it is aimed to determine the effect of foot reflexology applied to dialysis patients on sleep, anxiety and quality of life.
Study Overview
Detailed Description
Reflexology is defined as a holistic treatment based on stimulating the nerves and blood circulation in the body by manually stimulating the reflex points in the hands and feet corresponding to all parts of the body, organs and systems.
In the literature, there are many studies conducted in different samples to evaluate the effectiveness of reflexology massage.
Hemodialysis patients are also included in these samples.
Hemodialysis patients are faced with many physical and emotional symptoms such as lifestyle changes, psychosocial effects, side effects due to treatment, during their treatment process.
Nurses play an important role in alleviating and eliminating these complaints.
Objective: It is aimed to determine the effect of foot reflexology applied to dialysis patients on sleep, anxiety and quality of life.
Design: Randomized, controlled, prospective study.
Setting: University Hospital Hemodialysis Center in Izmir.
Patients: Forty patients receiving hemodialysis treatment.
Interventions: Nine sessions of reflexology massage will be given to reflex points including the solar plexus, brain, pituitary, thyroid, diaphragm, upper lymphs, lung, spinal cord and adrenal glands.
Main Outcome Measures: sleep, anxiety, and quality of life.
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
İzmir, Turkey, 35340
- Başkent University, İzmir Çiğli Dialysis Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 83 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Conscious and oriented with no communication problem
- Agreeing to participate in the study
- Receiving hemodialysis treatment 3 times a week for 6 months or more
- Patients who have no problem to apply massage; Those who do not have any skin lesions, burns, pathological diseases related to muscles and bones, phlebitis, embolism or bleeding disorder.
Exclusion Criteria:
- Patients who have received hemodialysis treatment for less than 6 months.
- Patients with diabetic neuropathy
- Those who have any skin lesions, burns, open wounds, muscle and bone-related pathological disease, phlebitis, embolism or bleeding disorder in the foot.
- Patients with infection
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention
informed consent forms, nine sessions of foot reflexology massage will be given to reflex points including the solar plexus, brain, pituitary, thyroid, diaphragm, upper lymphs, lung, spinal cord and adrenal glands for 3 weeks.
Then data collection tools were applied.
|
Reflexology is massage therapy used to maintain and improve health, as well as relieve some symptoms.
|
Placebo Comparator: Control
informed consent forms, foot massage were performed.
Then data collection tools were applied.
|
Reflexology is massage therapy used to maintain and improve health, as well as relieve some symptoms.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
sleep
Time Frame: nine sessions of foot reflexology massage will be given to reflex points including the solar plexus, brain, pituitary, thyroid, diaphragm, upper lymphs, lung, spinal cord and adrenal glands for 3 weeks.
|
improvement in sleep quality.
The patients' sleep quality score were collected by the Richard-Campbell Sleep Questionnaire.
The scale has a 100-mm line with words describing the poorest possible sleep (0 mm) to the best possible sleep (100 mm).
|
nine sessions of foot reflexology massage will be given to reflex points including the solar plexus, brain, pituitary, thyroid, diaphragm, upper lymphs, lung, spinal cord and adrenal glands for 3 weeks.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
anxiety
Time Frame: nine sessions of foot reflexology massage will be given to reflex points including the solar plexus, brain, pituitary, thyroid, diaphragm, upper lymphs, lung, spinal cord and adrenal glands for 3 weeks.
|
reduce anxiety.
The patients' anxiety score data were collected by the State Anxiety Inventory.
It is a 20-item scale.
The scores in the inventory range from 20 to 80. Higher points show a higher level of anxiety.
|
nine sessions of foot reflexology massage will be given to reflex points including the solar plexus, brain, pituitary, thyroid, diaphragm, upper lymphs, lung, spinal cord and adrenal glands for 3 weeks.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Gülşah Gürol Arslan, PhD, Associate Professor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 12, 2020
Primary Completion (Actual)
June 20, 2021
Study Completion (Actual)
June 20, 2021
Study Registration Dates
First Submitted
February 12, 2021
First Submitted That Met QC Criteria
February 12, 2021
First Posted (Actual)
February 16, 2021
Study Record Updates
Last Update Posted (Actual)
June 22, 2022
Last Update Submitted That Met QC Criteria
June 20, 2022
Last Verified
June 1, 2022
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Issue: 2020/29-48
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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