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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04756999
Other study ID # Issue: 2020/29-48
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 12, 2020
Est. completion date June 20, 2021

Study information

Verified date June 2022
Source Dokuz Eylul University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date June 20, 2021
Est. primary completion date June 20, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
massage therapy
Reflexology is massage therapy used to maintain and improve health, as well as relieve some symptoms.

Locations

Country Name City State
Turkey Baskent University, Izmir Çigli Dialysis Center Izmir

Sponsors (1)

Lead Sponsor Collaborator
Dokuz Eylul University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary sleep 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 anxiety 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.
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