The Effect of Foot Reflexology Applied on Dialysis Patients

Sponsor
Dokuz Eylul University (Other)
Overall Status
Completed
CT.gov ID
NCT04756999
Collaborator
(none)
40
1
2
17.2
2.3

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: massage therapy
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomised Controlled TrialRandomised Controlled Trial
Masking:
Single (Participant)
Masking Description:
Single Blind Randomised Controlled Trial
Primary Purpose:
Supportive Care
Official Title:
The Effect of Foot Reflexology Applied to Dialysis Patients on Quality of Life and Symptom Control: A Randomized Clinical Trial
Actual Study Start Date :
Jan 12, 2020
Actual Primary Completion Date :
Jun 20, 2021
Actual Study Completion Date :
Jun 20, 2021

Arms and Interventions

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.

Behavioral: massage therapy
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.

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

Outcome Measures

Primary Outcome Measures

  1. sleep [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).

Secondary Outcome Measures

  1. 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.]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Başkent University, İzmir Çiğli Dialysis Center İzmir Turkey 35340

Sponsors and Collaborators

  • Dokuz Eylul University

Investigators

  • Principal Investigator: Gülşah Gürol Arslan, PhD, Associate professor

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Gizem Göktuna, Research Assistant, Dokuz Eylul University
ClinicalTrials.gov Identifier:
NCT04756999
Other Study ID Numbers:
  • Issue: 2020/29-48
First Posted:
Feb 16, 2021
Last Update Posted:
Jun 22, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Gizem Göktuna, Research Assistant, Dokuz Eylul University

Study Results

No Results Posted as of Jun 22, 2022