Protocol summary
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Study aim
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Determining the effect of foot reflexology on pain intensity associated with insertion of a needle into an AVF in hemodialysis patients
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Design
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Clinical trial with control group, with parallel groups, single-blind, randomized, on 60 patients. For randomization, a computer random number table with blocks of four and six with a ratio of 1:1 was used.
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Settings and conduct
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Female patients with AVF referred to Imam Reza Hospital in Tabriz will be selected by available methods and after reviewing the basic characteristics of patients will be randomly divided into two groups. In the intervention phase, each group will be evaluated for three sessions. In the intervention group, first the physiological parameters of the patients will be evaluated and then the foot reflexology will be performed for 20 minutes. After that, a needle is inserted and Information will be recorded. In the control group, information is recorded without intervention. Blinding will be done with the help of a researcher who is not familiar with the goals of the project.
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Participants/Inclusion and exclusion criteria
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Inc:
1. Being 18 years old and older
2. Having full consciousness
3. History of hemodialysis for at least 3 months from the desired fistula
Exc:
1. Candidate for kidney transplant
2. Death of the patient or withdrawal from the study
3. Get painkillers 12-8 before hemodialysis
4. Drug addiction
5. Neuropathological problems of skin diseases in the patient's legs
6. Any type of wound and fracture, amputation and deep vein thrombosis in the legs
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Intervention groups
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In the intervention group, during three sessions, first the physiological parameters of the patients are evaluated and then the reflexology of the foot will be performed for 20 minutes. Are recorded without intervention.
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Main outcome variables
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The effectiveness of reflexology on reducing pain when a needle is inserted into a fistula
General information
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Reason for update
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Some final changes were omitted.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20200825048518N1
Registration date:
2020-11-25, 1399/09/05
Registration timing:
prospective
Last update:
2020-11-26, 1399/09/06
Update count:
1
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Registration date
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2020-11-25, 1399/09/05
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2020-12-05, 1399/09/15
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Expected recruitment end date
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2021-05-22, 1400/03/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The effect of foot reflexology on pain intensity associated with needle insertion into arteriovenous fistula in hemodialysis patients: a parallel randomized clinical trial study
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Public title
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The effect of foot reflexology on pain intensity associated with fistula needle insertion
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Being 18 years old and older
Having full consciousness
History of hemodialysis for at least 3 months from the desired fistula
Exclusion criteria:
Candidate for kidney transplant
Patient death or withdrawal
Get painkillers 12-8 before hemodialysis
Drug addictions
Neuropathological problems of skin diseases in the patient's legs
Any type of wound and fracture, amputation and deep vein thrombosis in the leg
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Age
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From 18 years old
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Gender
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Female
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Phase
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N/A
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Groups that have been masked
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Sample size
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Target sample size:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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The patients who will enter the study will be randomly assigned to two groups (reflexology recipient and one group receiving routine care) in a ratio of 1: 1 using a computer random number table with blocks of four and six. Blocking will be done by a non-involved person in sampling who is not aware of the objectives of the study, and the type of intervention received will be written on paper and numbered in a series of opaque envelopes (Allocation Concealment).
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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The assistance of a researcher who registers the parameters and is unaware of the allocation groups will be considered a blind member.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2020-11-25, 1399/09/05
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Ethics committee reference number
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IR.TBZMED.REC.1399.809
Health conditions studied
1
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Description of health condition studied
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Hemodialysis
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ICD-10 code
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Z49.01
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ICD-10 code description
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Encounter for fitting and adjustment of extracorporeal dialysis catheter
Primary outcomes
1
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Description
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pain
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Timepoint
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When inserting a needle into a venous artery fistula
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Method of measurement
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Pain intensity in patients with arteriovenous fistula using the VAS instrument, which is a rule-like diagram numbered from zero to ten; Will be evaluated. The Linear-Visual Pain Scale is divided from zero to ten so that zero means painless and ten means maximum pain.
2
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Description
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Physiological parameters
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Timepoint
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Before and immediately after insertion of the needle into the venous artery fistula
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Method of measurement
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Blood pressure and heart rate with a physiological device for measuring digital blood pressure and blood oxygen saturation level by a device for measuring blood oxygen saturation level
Intervention groups
1
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Description
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Intervention group: After the necessary coordination with the center and due to the current situation in the medical centers, after wearing personal protective equipment, the researcher and the research assistant will be present at the patient's bedside. After the patient enters the ward and is placed in a dialysis bed that has a well-lit and well-ventilated environment and is quiet, the intervention will begin after the necessary coordination with the head of the ward. After ensuring that the patient's legs are clean in a comfortable, semi-sitting position with the head at a 30-degree angle to the body and a small pillow under the legs for comfort, the fistula needle is placed by each patient's fixed nurse in shifts. Morning and evening work will be done in the dialysis ward of Imam Reza (AS) Hospital in Tabriz. In each session, only two patients will be evaluated. Five minutes after cleaning the skin surface with a 70% alcohol-soaked cotton swab, a hemodialysis needle will be inserted into the fistula area by each patient's fixed nurse. In all cases, the fistula needle is the same in terms of size (No. 16), shape and manufacturer and will enter the patient fistula at an angle of 20-30 degrees. The duration of each reflexology session will be 20 minutes starting from the right foot and continuing with the left foot (10 minutes reflexology for the right foot and 10 minutes reflexology for the left foot). Massage all parts of the right foot for 5 minutes, then massage for 5 minutes on the kidneys, under the big toe and the star network (solar plexus), then repeat these steps for the left foot. Foot reflexology by researchers After washing the hands, according to the patient's preference, his feet will be cleaned with water or a wet handkerchief. To prevent friction, turquoise baby oil made in Iran at room temperature, which has no therapeutic properties, will be used. During the intervention, the researcher will support the patient's foot with one hand and massage with the fingers of the other hand (mostly the big toe) with a gentle pressure as far as the patient can bear. In the reflexology group, patients with arteriovenous fistulas will be evaluated and recorded by a researcher after completing a 20-minute foot massage and immediately after the fistula needle is inserted. Physiological parameters are evaluated by the researcher before the intervention and then reflexology is performed for twenty minutes. After reflexology is completed, the fistula needle is inserted into the fistula by the ward nurse, after which the physiological parameters of the patients will be evaluated and recorded again by the researcher.
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Category
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Other
2
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Description
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Control group: They will receive routine care, assessment of pain intensity and physiological parameters will be performed simultaneously with the reflexology group.
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Category
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Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Tabriz University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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Study data can be published after the journals are accepted and published
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When the data will become available and for how long
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Access period starts 6 months after the results are published
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To whom data/document is available
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People who want to help hemodialysis patients are allowed to use the data
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Under which criteria data/document could be used
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People who are researcher
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From where data/document is obtainable
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The person in charge of the study
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What processes are involved for a request to access data/document
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Prove the purpose of the data request, which is to help hemodialysis patients, then send an email to the responsible author
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Comments
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