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The effect of warm moist compresses Calendula ointment Infusion in phlebitis of dextrose 50% through the peripheral veins in Emam Khomeini hospital

Protocol summary

Summary
Objective; Phlebitis due to peripheral venous infusion of dextrose 50%, and its comparison with the standard method of applying hot and humid, in the years 1396-1395 was conducted in Tehran. Design and settingand conduct: This study is a clinical trial on 128 patients with 50% dextrose infusion catheter phlebitis due to peripheral veins. The samples were randomly divided into four groups of 32 people, including warm compresses wet, calendula ointment, and each divided control, Place IV catheters has been studied since the beginning of phlebitis, phlebitis after starting the catheter removed and replaced in another location. Participants including major eligiblity criteria; Lack of a history of asthma and allergy to Calendula ointment; Lack of intravenous anticoagulant ; Having access to prescription; Having age between 20-70; Having consciousness and the ability to participate in the study; Lack of skin diseases in the area of phlebitis; Phlebitis caused by infusion of dextrose 50%. Intervention; In intervention groups for 3 days and at intervals of 8 hours, ointment Calendula (2 × 4cm = 2 / 5gr) or compresses hot and humid (20 minutes) at phlebitis went to work. In the control group did not, Severity of phlebitis before intervention and every day to 3 days based on a scale of five degrees of phlebitis Jackson wasThe main outcome variables: phlebitis, warm moist compresses, ointment Calendula, dextrose, peripheral veins .

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017060334306N1
Registration date: 2017-06-18, 1396/03/28
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-06-18, 1396/03/28
Registrant information
Name
Neda Joorabloo
Name of organization / entity
Islamic Azad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 4446 2895
Email address
n.joorabloo@iautmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2016-12-30, 1395/10/10
Expected recruitment end date
2017-04-30, 1396/02/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of warm moist compresses Calendula ointment Infusion in phlebitis of dextrose 50% through the peripheral veins in Emam Khomeini hospital
Public title
Calendula ointment effect on phlebitis induced by infusion of dextrose 50% through the peripheral veins
Purpose
Supportive
Inclusion/Exclusion criteria
Participants including major eligibility criteria: Lack of a history of asthma and allergy to Calendula ointment; Lack of intravenous anticoagulant steroid; Having age between 20-70; Having consciousness and the ability to participate in the study; Lack of skin diseases in the area of phlebitis; Phlebitis caused by infusion of dextrose 50%. Participants excluding major eligibility criteria; Lack of desire to continue cooperation in the study; Failure to use correct and timely Calendula ointment and warm moist compresses during the study.
Age
From 30 years old to 79 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 128
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
does not have

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee Islamic Azad University, Tehran Medical Unit
Street address
Zargande aveneue، Tehran
City
Tehran
Postal code
Approval date
2017-01-03, 1395/10/14
Ethics committee reference number
IR.IAU.TMU.REC.1395.273

Health conditions studied

1

Description of health condition studied
Phlebitis
ICD-10 code
I80
ICD-10 code description
Phlebitis and thrombophlebitis

Primary outcomes

1

Description
Calendula ointment healing effect on phlebitis
Timepoint
3 days after the intervention.
Method of measurement
Scale Jackson

Secondary outcomes

empty

Intervention groups

1

Description
The intervention groups: Calendula ointment (Dine) use 2.5 g every 8 hours for 3 over skin days after the onset of phlebitis and the other intervention group warm wet compress use 20 minutes every 8 hours for 3 days over skin after the onset of phlebitis.   Control groups: placebo was measured not only daily phlebitis
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Department of Surgery Imam Khomeini Hospital
Full name of responsible person
Neda Joorabloo
Street address
Bagherkhan Street
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research Tehran Azad University Medical
Full name of responsible person
Amir Fakhar
Street address
Zargande avenue, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research Tehran Azad University Medical
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Islamic Azad University, Tehran Medical Branch
Full name of responsible person
Tahereh Nasrabadi
Position
HEAD OF College
Other areas of specialty/work
Street address
Zargande Avenue
City
Tehran
Postal code
Phone
+98 21 2263 4874
Fax
Email
taherehnasrabadi2009@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University of Medical Sciences
Full name of responsible person
Tahereh Nasrabadi
Position
PHD
Other areas of specialty/work
Street address
Zargandeh Avenue
City
Tehran
Postal code
Phone
+98 21 2263 4874
Fax
Email
taherehnasrabadi2009@gmail.com
Web page address

Person responsible for updating data

Contact

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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