Purpose: This study will be conducted to determine the effect of external use of Sesame oil (SO) in prevention of chemotherapy-induced phlebitis. Materials & Methods: 60 patients with Acute Lymphocytic Leukemia(ALL), who admitted for chemotherapeutic management, will be enrolled in a clinical trial and they will be randomly divided in two equal, control & intervention, groups. They will use 10 drops of SO every 12 hours, two times a day, from the first day of chemotherapy up to the thirtieth day. In control group liquid paraffin as placebo. The amount and method of using liquid paraffin is as exactly same as using of sesame oil in the experimental group. Data tools included a bipartite questionnaire (demographic Q & clinical Q) and Visual infusion phlebitis Scale (VIP) for measurement of phlebitis in two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015101924594N1
Registration date:2015-11-12, 1394/08/21
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-11-12, 1394/08/21
Registrant information
Name
Seyedeh Zahra Shafipour
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 3344 0202
Email address
shafipur@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Guilan University of Medical Sciences
Expected recruitment start date
2015-11-11, 1394/08/20
Expected recruitment end date
2016-05-09, 1395/02/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of topical Sesame Oil in the Prevention of Chemotherapy-Induced Phlebitis in 17 Shahrivar Hospital
Public title
Evaluation of the effect of topical Sesame Oil in the Prevention of Chemotherapy-Induced Phlebitis in 17 Shahrivar Hospital
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: consciousness; age 1-14 years; admitted to hospital with ALL; chemotherapeutic management with Adriamycin & vincristine; Application No. 22-24 catheter medifllon Company; catheterization into arm vein; No septic conditions during catheterization; Underlying Co-morbidity (diabetes, infections, and hypertension); underlying fever and neutropenia; any broad spectrum antibiotic & narcotic analgesic in the patient medication instructions no received antibiotic & narcotic analgesic; received another Vegetable oil or drug; history of Sesame family allergy. Exclusion criteria: Vessel rupture due to nursing error; Lack of chemotherapy drugs under the skin and surrounding tissues.
Age
From 1 year old to 14 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Guilan University of Medical Sciences
Street address
Guilan University of Medical Sciences, in front of Sepah Bank, West Beheshti blvd., Rasht
City
Rasht
Postal code
4193893345
Approval date
2015-10-06, 1394/07/14
Ethics committee reference number
285
Health conditions studied
1
Description of health condition studied
phlebitis
ICD-10 code
T80.1
ICD-10 code description
Vascular complications following infusion, transfusion and therapeutic injection
Primary outcomes
1
Description
Phlebitis
Timepoint
Daily
Method of measurement
visual infusion phlebitis scale
Secondary outcomes
1
Description
Pain, Erythema, Swelling
Timepoint
Daily
Method of measurement
visual infusion phlebitis scale
Intervention groups
1
Description
Intervention 1: 10 drops of Sesame oil for external using, every 12 hours, two times a day, from the first day of chemotherapy up to the thirtieth day.
Category
Prevention
2
Description
In control group paraffin as placebo. The amount and method of using liquid paraffin is as exactly same as using of sesame oil in the experimental group.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
17 Shahrivar Hospital
Full name of responsible person
Seyedeh Zahra Shafipour
Street address
Nursing and midwiffery school, Daneshjo st., Beheshti Highway, Rasht.
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Abtin Heidarzadeh
Street address
Research and Technology affairs building, in front of Sepah Bank, West Beheshti blvd., Rasht
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Guilan University of Medical Sciences
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
Guilan University of Medical Sciences
Full name of responsible person
Seyedeh Zahra Shafipour
Position
Faculty member
Other areas of specialty/work
Street address
Nursing and midwiffery school, Daneshjo st., Beheshti Highway, Rasht
City
Rasht
Postal code
4146939841
Phone
+98 13 3355 5056
Fax
+98 13 3355 5098
Email
shafipur@gums.ac.ir
Web page address
WWW.gums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Seyedeh Zahra Shafipour
Position
Faculty member
Other areas of specialty/work
Street address
Nursing and midwiffery school, Daneshjo st., Beheshti Highway, Rasht
City
Rasht
Postal code
4146939841
Phone
+98 13 3355 5056
Fax
+98 13 3355 5098
Email
shafipur@gums.ac.ir
Web page address
WWW.gums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Nadia Mosayebi
Position
Ms
Other areas of specialty/work
Street address
Nursing and midwiffery school, Daneshjo st., Beheshti Highway, Rasht
City
Rasht
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)