History
# Registration date Revision Id
2 2018-07-02, 1397/04/11 54637
1 2018-04-14, 1397/01/25 42306
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  • Protocol summary

    Comparison and determination of the effect of purple ointment on the pain caused by fistula cannulation in hemodialysis patients in the two intervention and control (placebo) groups
    Effect of purple ointment on the pain caused by fistula cannulation in hemodialysis patients
    For randomization, the method of permuted blocks (15 dual blocks ) is used.
    Permuted block randomization (15 dual blocks) will be the randomization method.
    Both intervention and control groups are consisted 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 length of 5 cm) will be covered with some purslane ointment. Two minutes before the Venipuncture, the position is cleared for disinfection and during the Venipuncture, the patient expresses the pain intensity and the assistant researcher records the score. The same process applies to the control group using placebo instead of purslane ointment.
    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.
    هردو گروه مداخله و کنترل، بیماران دیالیزی واجد شرایط هستند که وارد پژوهش میشوند. در گروه مداخله نیم ساعت قبل از رگ گیری، موضع مورد نظر به کمک پماد خرفه با وسعت یک مربع به ضلع 5 سانتیمتر پوشانده خواهد شد. دو دقیقه قبل از رگ گیری، موضع برای انجام فرآنید های ضدعفونی پاک شده و در هنگام رگ گیری، مددجو نمره درد را بیان کرده و دستیار پژوهشگر آنرا ثبت میکند. همین فرآیند در مورد گروه با استفاده از پلاسبو صادق است.
    هردو گروه مداخله و کنترل، بیماران دیالیزی واجد شرایط هستند که وارد پژوهش میشوند. در گروه مداخله نیم ساعت قبل از رگ گیری، موضع مورد نظر به کمک پماد خرفه با وسعت یک مربع به ضلع 5 سانتیمتر پوشانده خواهد شد. دو دقیقه قبل از رگ گیری، موضع برای انجام فرآیند های ضدعفونی پاک شده و در هنگام رگ گیری، مددجو نمره درد را برروی خط کش مدرج 100 میلیمتری علامت گذاری کرده، سپس دستیار پژوهشگر فاصله نقطه ابتدای خط کش تا محل علامت را اندازه گرفته و آنرا ثبت می کند. همین فرآیند در مورد گروه با استفاده از پلاسبو صادق است.
  • Intervention groups

    #1
    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 kneading, the position is cleared for disinfection and during the kneading, the patient expresses the pain score and records the assistant researcher
    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.
    گروه مداخله: در گروه مداخله نیم ساعت قبل از رگ گیری، موضع مورد نظر به کمک پماد خرفه با دوز 10 درصد با وسعت یک مربع به ضلع 5 سانتیمتر پوشانده خواهد شد. دو دقیقه قبل از رگ گیری، موضع برای انجام فرآیند های ضدعفونی پاک شده و در هنگام رگ گیری، مددجو نمره درد را بیان کرده و دستیار پژوهشگر آنرا ثبت می کند.
    گروه مداخله: در گروه مداخله نیم ساعت قبل از رگ گیری، موضع مورد نظر به کمک پماد خرفه با دوز 10 درصد با وسعت یک مربع به ضلع 5 سانتیمتر پوشانده خواهد شد. دو دقیقه قبل از رگ گیری، موضع برای انجام فرآیند های ضدعفونی پاک شده و در هنگام رگ گیری، مددجو نمره درد را برروی خط کش مدرج 100 میلیمتری علامت گذاری کرده، سپس دستیار پژوهشگر فاصله نقطه ابتدای خط کش تا محل علامت را اندازه گرفته و آنرا ثبت می کند.
    #2
    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 kneading, the position is cleared for disinfection and during the kneading, the patient expresses the pain score and records the assistant researcher.
    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.
    گروه کنترل: در گروه کنترل نیم ساعت قبل از رگ گیری، موضع مورد نظر به کمک پماد ویتامین آ با وسعت یک مربع به ضلع 5 سانتیمتر پوشانده خواهد شد. دو دقیقه قبل از رگ گیری، موضع برای انجام فرآنید های ضدعفونی پاک شده و در هنگام رگ گیری، مددجو نمره درد را بیان کرده و دستیار پژوهشگر آنرا ثبت میکند.
    گروه کنترل: در گروه کنترل نیم ساعت قبل از رگ گیری، موضع مورد نظر به کمک پماد ویتامین آ با وسعت یک مربع به ضلع 5 سانتیمتر پوشانده خواهد شد. دو دقیقه قبل از رگ گیری، موضع برای انجام فرآیند های ضدعفونی پاک شده و در هنگام رگ گیری، مددجو نمره درد را برروی خط کش مدرج 100 میلیمتری علامت گذاری کرده، سپس دستیار پژوهشگر فاصله نقطه ابتدای خط کش تا محل علامت را اندازه گرفته و آنرا ثبت می کند.
  • Recruitment centers

    #1
    Name of recruitment center - English: Imam reza hospital
    Name of recruitment center - Persian: بیمارستان امام رضا
    Full name of responsible person - English: Hamid Dehghan Haqiqi
    Full name of responsible person - Persian: حمید دهقان حقیقی
    Street address - English: Mashhad - Ibn Sina St. - The margin of Imam Reza Square (AS)
    Street address - Persian: مشهد - خیابان ابن سینا - حاشیه میدان امام رضا (ع)
    City - English: Mashahd
    City - Persian: مشهد
    Province: Razavi Khorasan
    Country: Iran (Islamic Republic of)
    Postal code: 9691945182
    Phone: +98 51 3802 2000
    Fax:
    Email: Moallef@gmail.com
    Web page address:
    Name of recruitment center - English: Imam Reza hospital
    Name of recruitment center - Persian: بیمارستان امام رضا
    Full name of responsible person - English: Hamid Dehghan Haqiqi
    Full name of responsible person - Persian: حمید دهقان حقیقی
    Street address - English: Imam Reza hospital, The margin of Imam Reza Square (AS), Ibn Sina St, Mashhad, Iran.
    Street address - Persian: مشهد - خیابان ابن سینا - حاشیه میدان امام رضا (ع)
    City - English: Mashahd
    City - Persian: مشهد
    Province: Razavi Khorasan
    Country: Iran (Islamic Republic of)
    Postal code: 9691945182
    Phone: +98 51 3802 2000
    Fax:
    Email: Moallef@gmail.com
    Web page address:
    #2
    Name of recruitment center - English: Bohlol Hospital
    Name of recruitment center - Persian: بیمارستان بهلول
    Full name of responsible person - English: Hamid Dehghan Haqiqi
    Full name of responsible person - Persian: حمید دهقان حقیقی
    Street address - English: Iran, Gonabad, Asian Roads, Gonabad University of Medical Sciences
    Street address - Persian: ایران، گناباد، حاشیه جاده آسیایی، دانشگاه علوم پزشکی گناباد
    City - English: Gonabad
    City - Persian: گناباد
    Province: Razavi Khorasan
    Country: Iran (Islamic Republic of)
    Postal code: 9691793718
    Phone: +98 51 5722 3028
    Fax:
    Email: h.dehghan.haqiqi@gmail.com
    Web page address:
    Name of recruitment center - English: Bohlol Hospital
    Name of recruitment center - Persian: بیمارستان بهلول
    Full name of responsible person - English: Hamid Dehghan Haqiqi
    Full name of responsible person - Persian: حمید دهقان حقیقی
    Street address - English: Gonabad University of Medical Sciences, Asian Roads, Gonabad, Khorasan Razavi, Iran
    Street address - Persian: ایران، گناباد، حاشیه جاده آسیایی، دانشگاه علوم پزشکی گناباد
    City - English: Gonabad
    City - Persian: گناباد
    Province: Razavi Khorasan
    Country: Iran (Islamic Republic of)
    Postal code: 9691793718
    Phone: +98 51 5722 3028
    Fax:
    Email: h.dehghan.haqiqi@gmail.com
    Web page address:
  • Sponsors / Funding sources

    #1

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Dr. Seyed Ali Sajjadi
    Full name of responsible person - Persian: دکتر سید علی سجادی
    Street address - English: Iran, Gonabad, Asian Roads, Gonabad University of Medical Sciences
    Street address - Persian: گناباد
    City - English: Gonabad
    City - Persian: ایران، گناباد، حاشیه جاده آسیایی، دانشگاه علوم پزشکی گناباد
    Province: Razavi Khorasan
    Country: Iran (Islamic Republic of)
    Postal code: 9691793718 تلفن+98 5
    Phone: +98 51 5722 3028
    Fax:
    Email: moallef@gmail.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Dr. Seyed Ali Sajjadi
    Full name of responsible person - Persian: دکتر سید علی سجادی
    Street address - English: Gonabad University of Medical Sciences, Asian Roads, Gonabad, Khorasan Razavi, Iran
    Street address - Persian: گناباد
    City - English: Gonabad
    City - Persian: ایران، گناباد، حاشیه جاده آسیایی، دانشگاه علوم پزشکی گناباد
    Province: Razavi Khorasan
    Country: Iran (Islamic Republic of)
    Postal code: 9691793718 تلفن+98 5
    Phone: +98 51 5722 3028
    Fax:
    Email: moallef@gmail.com
    Web page address:

Protocol summary

Study aim
Effect of purple ointment on the pain caused by fistula cannulation in hemodialysis patients
Design
Permuted block randomization (15 dual blocks) will be the randomization method.
Settings and conduct
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.
Participants/Inclusion and exclusion criteria
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.
Intervention groups
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.
Main outcome variables
pain

General information

Reason for update
Acronym
IRCT registration information
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
Registration date
2018-04-14, 1397/01/25
Registrant information
Name
Amirreza Nasirzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5722 3028
Email address
nasirzadeh@gmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-02-20, 1396/12/01
Expected recruitment end date
2018-05-20, 1397/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of topical Purslane (Portulaca Oleracea) on the pain intensity during cannulation among hemodialysis patients: double blind randomized clinical trial
Public title
Effect of topical Purslane (Portulaca Oleracea) on the pain intensity during cannulation in hemodialysis patients
Purpose
Supportive
Inclusion/Exclusion criteria
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
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
For randomization, the method of permuted blocks (15 dual blocks ) is used.
Blinding (investigator's opinion)
Double blinded
Blinding description
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.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Gonabad University of Medical Sciences
Street address
Gonabad University of Medical Sciences, Asian Roads, Gonabad, Khorasan Razavi, Iran
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Approval date
2018-01-03, 1396/10/13
Ethics committee reference number
IR.GMU.REC.1396.100

Health conditions studied

1

Description of health condition studied
Chronic renal failure
ICD-10 code
N18.5
ICD-10 code description
Chronic kidney disease, stage 5

Primary outcomes

1

Description
pain
Timepoint
First, second and third hemodialysis sessions
Method of measurement
Visual Analogue Scale

Secondary outcomes

empty

Intervention groups

1

Description
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.
Category
Treatment - Drugs

2

Description
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.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza hospital
Full name of responsible person
Hamid Dehghan Haqiqi
Street address
Imam Reza hospital, The margin of Imam Reza Square (AS), Ibn Sina St, Mashhad, Iran.
City
Mashahd
Province
Razavi Khorasan
Postal code
9691945182
Phone
+98 51 3802 2000
Email
Moallef@gmail.com

2

Recruitment center
Name of recruitment center
Bohlol Hospital
Full name of responsible person
Hamid Dehghan Haqiqi
Street address
Gonabad University of Medical Sciences, Asian Roads, Gonabad, Khorasan Razavi, Iran
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 3028
Email
h.dehghan.haqiqi@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Dr. Seyed Ali Sajjadi
Street address
Gonabad University of Medical Sciences, Asian Roads, Gonabad, Khorasan Razavi, Iran
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718 تلفن+98 5
Phone
+98 51 5722 3028
Email
moallef@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gonabad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Amirreza Nasirzadeh
Position
ُStudent
Latest degree
A Level or less
Other areas of specialty/work
Nursery
Street address
Gonabad University of Medical Sciences, Asian Roads, Gonabad, Khorasan Razavi, Iran
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 3028
Email
nasirzadeh@gmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Mehdi Basiri Moghadam
Position
Master of science in Nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Gonabad University of Medical Sciences, Asian Roads, Gonabad, Khorasan Razavi, Iran
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 53 3733 2629
Email
basiri1344@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Amirreza Nasirzadeh
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Nursery
Street address
Gonabad University of Medical Sciences, Asian Roads, Gonabad, Khorasan Razavi, Iran
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 3028
Email
nasirzadeharnz@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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