Protocol summary

Study aim
Comparison the Effect of Thymus Vulgaris and Purslane (Portulaca Oleracea) Ointment on the pain intensity during cannulation
Design
This trial has three parallel groups including the purslane group, the thyme group and the placebo group. The estimated sample size for this study is 48 people who will be divided into three groups by simple random sampling method.
Settings and conduct
The study will be conducted blindly at Gonabad University of Medical Sciences. In this study, the researchers are blind to the allocation of purslane and thyme and placebo blind groups. Demographic data and clinical status, scale were also collected to collect data. Visual pain will be used.
Participants/Inclusion and exclusion criteria
Age 18 years and over, at least 3 months history of hemodialysis, verbal, mental and visual disability, antinociceptive dependence, pre-cannulation pain, no analgesics, Thymus Vulgaris and purslane 24 hours before hemodialysis, no ulceration Fistula, no liver disorders, asthma, allergy and dermatitis, no known allergy or allergy to Thymus Vulgaris and purslane, no alcohol and drugs, no history of mental illness and hospitalization, are the criteria for entry. Patient's unwillingness to continue research, occurrence of any adverse drug reaction or response during intervention, failure to perform cannulation In the first act and the need for repeated cannulation, death or migration patient Exclusion criteria are
Intervention groups
The intervention group will use 5% purslane ointment and 5% Thymus Vulgaris ointment. The control group will receive placebo (vitamin A + D ointment).
Main outcome variables
Pain

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20181029041495N3
Registration date: 2019-08-06, 1398/05/15
Registration timing: registered_while_recruiting

Last update: 2019-08-06, 1398/05/15
Update count: 0
Registration date
2019-08-06, 1398/05/15
Registrant information
Name
Mohsen Aliakbari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5733 2028
Email address
aliakbari.m.stu@gmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-27, 1398/05/05
Expected recruitment end date
2020-06-25, 1399/04/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the Effect of Thymus Vulgaris and Purslane (Portulaca Oleracea) Ointment on the painintensity during cannulation
Public title
Comparison the Effect of Thymus Vulgaris and Purslane (Portulaca Oleracea) Ointment on the painintensity during cannulation
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
18 years and older At least 3 months history of hemodialysis Verbal, mental and visual disability No dependence on analgesic drugs No pain before cannulation No use of painkillers, Thymus Vulgaris and purslane 24 hours before hemodialysis No wound in the fistula area Lack of liver disorders, asthma, allergies and dermatitis No known allergies or allergies to Thymus Vulgaris and purslane No use alcohol and drugs No record of mental illness and hospitalization in a psychiatric hospital
Exclusion criteria:
Patient's unwillingness to continue research The day of any adverse drug reaction or reaction during the intervention Failure to perform successful cannulation at first attempt and need to repeat cannulation Death or migration of the patient
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 48
Randomization (investigator's opinion)
Randomized
Randomization description
For randomization, the 6-in-one reversal blocks method is used in three groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patient:Due to the use of purslane ointment and Thymus Vulgaris and vitamin A + D as placebo in tubes with similar appearance the patient is not able to distinguish them from each other.The researcher:The nurse is aware of the type of ointment used but gives the researcher no information. Due to the use of purslane ointment and Thymus Vulgaris and vitamin A + D as placebo in tubes with similar appearance the researcher is not able to distinguish them from each other.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,Iran
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Approval date
2019-07-28, 1398/05/06
Ethics committee reference number
IR.GMU.REC.1398.078

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
The first, second, third and fourth hemodialysis sessions
Method of measurement
Visual Analogue Scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group:In the intervention groups, the purslane group, the 5% purslane ointment, was rubbed 5 cm 21 minutes before needle insertion at the fistula site and covered with a transparent dressing. Thymus Vulgaris Group, 5% Thymus Vulgaris Ointment, will be rubbed 5 cm wide 21 minutes before needle insertion into the fistula and covered with a transparent dressing. Then in each group the ointment is completely cleaned and after disinfection of the area with 71% alcohol and iodine solution, intravenous cannulation is performed and pain intensity will be measured immediately by a trained nurse in all patients using a 100 mm gradient ruler.
Category
Prevention

2

Description
Control group: In the control group, vitamin A + D ointment will be rubbed for 21 minutes before the needle enters the fistula at 5 cm and covered with a transparent dressing. And the iodine solution, intravenous cannulation, and pain intensity will be measured immediately using a 100 mm calibrated ruler in all patients by a trained nurse.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Clinic of Bohlool Gonabadi Hospital
Full name of responsible person
Mohsen Aliakbari
Street address
Gonabad University of Medical Sciences,Asian Roads,Gonabad, Iran
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 3028
Email
mohsenaliakbari1998@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Dr. Shahla Khosravan
Street address
Gonabad University of Medical Sciences,Asian Roads,Gonabad, Iran
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 3028
Email
MMa_khosravan@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
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
Fatemeh Ggholamian
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Gonabad University of Medical Sciences,Asian Roads,Gonabad, Iran
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 3028
Email
gholamian.ft@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Mohsen Aliakbari
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Gonabad University of Medical Sciences,Asian Roads,Gonabad, Iran
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 3028
Email
mohsenaliakbari1998@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Hamidreza Ebrahimi Seno
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Gonabad University of Medical Sciences,Asian Roads,Gonabad,Iran
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 3028
Email
hamid.ebrahimi7050@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
Loading...