Purpose: This study has been conducted to determine the effect of external use of Sesame oil (SO) in prevention of chemotherapy-induced phlebitis. Materials & Methods: 60 patients with colon & rectum cancer, who admitted for chemotherapeutic management, were enrolled in a clinical trial and they 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 fourteenth day. Data tools included a bipartite questionnaire (demographic Q & clinical Q) and Royal College of Nursing –Infusion Therapy scale (2010) for measurement of phlebitis.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138903082846N7
Registration date:2011-01-26, 1389/11/06
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-01-26, 1389/11/06
Registrant information
Name
Tahereh Ashktorab
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2222 1543
Email address
t_ashktorab@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Private
Expected recruitment start date
2010-12-18, 1389/09/27
Expected recruitment end date
2011-02-09, 1389/11/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of external use of Sesame oil in the prevention of chemotherapy-induced phlebitis
Public title
Effect of external use of Sesame oil in the prevention of chemotherapy-induced phlebitis
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: consciousness/age 30-70 years/ admitted to hospital with colon or rectum cancer/ chemotherapeutic management with 5-fluorouracil / Application No. 20-18 catheter Supa Company/ catheterization into arm vein/ No septic conditions during catheterization. Exclusion criteria: 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.
Age
From 30 years old to 70 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)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The International Branch of Shahid Beheshti University of Medical Sciences
Street address
No.19, Shaheed Abbas Pour, Vali Asr
City
Tehran
Postal code
141553693
Approval date
2010-12-13, 1389/09/22
Ethics committee reference number
116/2910
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
Observation with a check list
Secondary outcomes
1
Description
Pain, Erythema, Swelling
Timepoint
Daily
Method of measurement
Observation with acheck list
Intervention groups
1
Description
Intervention: 10 drops of Sesame oil for external using, every 12 hours, two times a day, from the first day of chemotherapy up to the fourteenth day.
Category
Prevention
2
Description
Control: no intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Hosein Hospital
Full name of responsible person
Tahereh Ashktorab
Street address
Faculty of Nursing, Shahid Beheshti University of Medical Sciences
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Researcher
Full name of responsible person
Tahereh Ashktorab
Street address
Faculty of Nursing, Shahid Beheshti University of Medical Sciences
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Researcher
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
Faculty of Nursing, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Tahereh Ashktorab
Position
PhD
Other areas of specialty/work
Street address
Valiasr Street, Hiyhway Beginning Niayesh
City
Tehran
Postal code
Phone
+98 21 8865 5371
Fax
Email
t_ashktorab@sbmu.ac.irtashktorab@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of nursing , Shahid Beheshti University of Medical Sciences
Full name of responsible person
Tahereh Ashktorab
Position
PhD
Other areas of specialty/work
Street address
Faculty of nursing , Shahid Beheshti University of Medical Sciences, valiasr street
City
Tehran
Postal code
Phone
+98 21 8865 5371
Fax
Email
t_ashktorab@sbmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Faculty of nursing , Shahid Beheshti University of Medical Sciences,
Full name of responsible person
Niloofar Nekoozad
Position
Ms
Other areas of specialty/work
Street address
The International Branch of Shahid Beheshti University of Medical Sciences
City
Tehran
Postal code
Phone
Fax
Email
niloufarnekozad@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)