Protocol summary
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Study aim
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Effect of purple ointment on the pain caused by fistula cannulation in hemodialysis patients
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Design
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Permuted block randomization (15 dual blocks) will be the randomization method.
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Settings and conduct
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This clinical trial will be carried out in the dialysis departments of the hospitals in Behlul, Gonabad and Imam reza Hospital in Mashhad. Due to the use of a tube with the same appearance, the patient will be blind. The researcher will be blind as a result of recording the pain score by the researcher's assistant.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Age range of 18 to 60 years; awareness of time, place, and people at the time of data collection; basic literacy
Exclusion criteria: damaged skin at the intended region; allergy to Portulaca Oleracea; alcohol and drug consumption history; history of mental illness.
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Intervention groups
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Both intervention and control groups consist of eligible diabetic patients who enter the study. In the intervention group, half an hour before the venipuncture, the place (equal to a square with the length of 5 cm) will be covered with some purslane ointment. Two minutes before the placement, the location was cleared for disinfection processes, and during the cannulation, the patient marked the pain score on a 100 mm scale ruler, and then the researcher's assistant measured the distance from the beginning of the ruler to the location of the mark and records it. The same process applies to the control group using placebo instead of purslane ointment.
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Main outcome variables
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pain
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20171219037966N2
Registration date:
2018-04-14, 1397/01/25
Registration timing:
registered_while_recruiting
Last update:
2018-07-30, 1397/05/08
Update count:
1
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Registration date
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2018-04-14, 1397/01/25
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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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2018-02-20, 1396/12/01
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Expected recruitment end date
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2018-05-20, 1397/02/30
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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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Effect of topical Purslane (Portulaca Oleracea) on the pain intensity during cannulation among hemodialysis patients: double blind randomized clinical trial
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Public title
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Effect of topical Purslane (Portulaca Oleracea) on the pain intensity during cannulation in hemodialysis patients
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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Inclusion criteria:
Awareness of time, place and person at the time of data collection
At least the reading and writing skills
Age 18 to 60 years
Exclusion criteria:
History of mental illness
Alcohol drinking and drug use
The presence of damaged skin in the desired position
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Age
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From 18 years old to 60 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Investigator
- Outcome assessor
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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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For randomization, the method of permuted blocks (15 dual blocks ) is used.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Patient: Due to the use of porphyry ointment and vitamin A as a placebo in tubes with similar appearance, patients can not distinguish between them.
Researcher: The nurse is aware of the type of ointment used, but without knowing the researcher, they will be available to him. Due to the use of porphyry ointment and vitamin A as a placebo in tubes with similar appearance, researchers can not distinguish between them.
Ex post evaluator: The ointment has been used by the researcher at the position and the evaluator is not aware of the type of ointment used for each patient.
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Placebo
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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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2018-01-03, 1396/10/13
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Ethics committee reference number
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IR.GMU.REC.1396.100
Health conditions studied
1
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Description of health condition studied
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Chronic renal failure
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ICD-10 code
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N18.5
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ICD-10 code description
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Chronic kidney disease, stage 5
Primary outcomes
1
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Description
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pain
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Timepoint
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First, second and third hemodialysis sessions
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Method of measurement
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Visual Analogue Scale
Intervention groups
1
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Description
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Intervention group: In the intervention group, half an hour before the venipuncture, the position will be covered with a 5 cm side squash with the help of a purslane ointment 10%. Two minutes before the placement, the location was cleared for disinfection processes, and during the cannulation, the patient marked the pain score on a 100 mm scale ruler, and then the researcher's assistant measured the distance from the beginning of the ruler to the location of the mark and records it.
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Category
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Treatment - Drugs
2
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Description
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Control group: In the control group half an hour before the venipuncture, the position is covered with vitamin A ointment with a square of 5 cm side. Two minutes before the placement, the location was cleared for disinfection processes, and during the cannulation, the patient marked the pain score on a 100 mm scale ruler, and then the researcher's assistant measured the distance from the beginning of the ruler to the location of the mark and records it.
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Category
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Placebo
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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Gonabad 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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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available