Assessing the effect of topical sesame oil on pain severity caused by limb trauma in patients referring to Rasht Poursina Hospital.
Design
A randomized, triple-blind clinical trial. researchers,patients and statisticians are not aware of the study groups.
Settings and conduct
120 patients referred to the clinic of Pursina Hospital in Rasht with upper and lower extremity trauma are selected and randomly allocated to intervention group (sesame oil) and control (placebo)(Each group 60 subjects).
Patient, researcher and statistician are not aware of the type of groups.Sesame oil and the placebo are encoded before using by the researcher and the patient. Data is entered to Statistical Analysis software by code.
Participants/Inclusion and exclusion criteria
inclusion criteria: Patients aged 18-60 years with full consciousness; non-penetrating trauma of the upper or lower extremities; the time of the incident is 1-6 hours before the referral; Their pain is (based on the visual scale of pain) 3 to 6.
Non-inclusion criteria: Presence of fracture; bleeding; dislocation; amputation; foreign body; neural damage in injured limb; presence of fever; history of sensitivity or allergy to sesame.
Intervention groups
Intervention group : The trauma size is calculated using a flexible curved ruler and based on multiplying the length and width of the area by square centimeter.The traumatic area is washed with 100cc normal saline and poured sesame oil using a dropper on the trauma area (10 drops / 3.8cc oil per 250 cm² trauma area).A circular massage is given for 5 -7 minutes by finger tip.The first intervention is carried out by the researcher in the hospital and the next interventions at home by the patient (2 times a day to 3 days) after education.
In the control group, the procedure is similar to the intervention group, but instead of sesame oil, the placebo is used.
Main outcome variables
pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180701040297N2
Registration date:2019-03-25, 1398/01/05
Registration timing:prospective
Last update:2019-03-25, 1398/01/05
Update count:0
Registration date
2019-03-25, 1398/01/05
Registrant information
Name
Nazila Javadi-Pashaki
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 3355 2088
Email address
n.javadi@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-09, 1398/01/20
Expected recruitment end date
2019-09-11, 1398/06/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessing the Effect of Topical Sesame Oil on Severity of Pain in Patients with Limb Trauma
Public title
The Effect of Topical Sesame Oil on Severity of Pain in Patients with Limb Trauma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
the patients 18-60 years
non-penetrating trauma of the upper or lower extremities
occurrence of trauma between one to six hours prior to referral
pain score 3-6 on visual analogue scale
full consciousness
Exclusion criteria:
The presence of fractures in the injured limb
The presence of bleeding at the site of the trauma
dislocation of the injured limb
amputation of the injured limb
The presence of foreign body at the site of the trauma
The presence of neurological damage in trauma location
The presence of fever
history of sensitivity or allergy to sesame
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Gradually and in the event of having criteria for entering the study, the samples are allocated to 2 groups of intervention and placebo by randomized blocking method based on categories of trauma size (<100 cm2 />100 cm2) and age (18-40 years / 41-60 years old).
Blinding (investigator's opinion)
Triple blinded
Blinding description
The study is a randomized three-blind randomized clinical trial. researchers, patients and statisticians are not aware of the study groups. Sesame oil and placebo bottles are coded by research colleagues. They are given to the main researcher and patient no name and with code. Based on the specified codes, the information is entered into the software and analyzed by the statistics specialist.
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
Eastern Shahid Beheshti Boulvard
City
rasht
Province
Guilan
Postal code
93345-41938
Approval date
2019-02-04, 1397/11/15
Ethics committee reference number
IR.GUMS.REC.1397.437
Health conditions studied
1
Description of health condition studied
Patients are traumatized
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pain
Timepoint
The pain is totally evaluated 7 times; before the intervention on the first day and 30 minutes after each intervention for 3 days(Twice a day).
Method of measurement
The Visual Analogue Scale is used to measure the severity of pain that includes a continuous line with two initial and end points of zero to 10; Zero means no pain and 10 means the maximum pain intensity.
Secondary outcomes
1
Description
The amount of analgesic received during the intervention
Timepoint
At the end of the study
Method of measurement
Patient's document
Intervention groups
1
Description
Intervention group: After washing the area with normal saline, sesame oil (produced by Farabi Pharmaceutical Company) is poured on the area and then a circular massage is given with fingertip for 5 to 7 minutes. This intervention is done twice a day at home by patient and lasts for three days.
Category
Treatment - Other
2
Description
Control group: After washing the area with normal saline, placebo oil (A similar solution to the taste, color and appearance of sesame oil produced by Farabi Pharmaceutical Company) is poured on the area and then a circular massage is given with fingertip for 5 to 7 minutes. This intervention is done twice a day at home by patient and lasts for three days.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasht Poursina Hospital
Full name of responsible person
Dr. Nazila Javadi
Street address
Poursina Intersection
City
Rasht
Province
Guilan
Postal code
41937-13194
Phone
+98 13 3332 2444
Fax
+98 13 3333 9842
Email
poursina@gums.ac.ir
Web page address
http://www.gums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research and Technology Deputy of Guilan University of Medical Sciences
Full name of responsible person
شادمان نعمتی
Street address
خیابان نامجو - خیابان شهید سیادتی
City
Rasht
Province
Guilan
Postal code
39841-41469
Phone
+98 13 3333 5820
Fax
+98 13 3333 6395
Email
research@gums.ac.ir
Web page address
http://www.gums.ac.ir/research
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research and Technology Deputy of Guilan 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
Guilan University of Medical Sciences
Full name of responsible person
Mina Kafash Mohammadjani
Position
Postgraduate Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
College of Nursing and Midwifery, Daneshjoo street, Dr Beheshti highway
City
RASHT
Province
Guilan
Postal code
39841-41469
Phone
+98 13 3355 5056
Fax
+98 13 3355 0097
Email
M.kafash.1359@gmail.com
Web page address
http://www.gums.ac.ir/nmr
Person responsible for scientific inquiries
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Nazila Javadi
Position
Assisstant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
College of Nursing and Midwifery, Daneshjoo street, Dr Beheshti highway
City
RASHT
Province
Guilan
Postal code
39841-41469
Phone
+98 13 3355 5056
Fax
+98 13 3355 0097
Email
n.javadi@gums.ac.ir
Web page address
http://www.gums.ac.ir/nmr
Person responsible for updating data
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Nazila Javadi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
College of Nursing and Midwifery, Daneshjoo street, Dr Beheshti highway
City
Rasht
Province
Guilan
Postal code
39841-41469
Phone
+98 13 3355 5056
Fax
+98 13 3355 0097
Email
n.javadip@gmail.com
Web page address
http://www.gums.ac.ir/nmr
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data is shared after the people became unidentifiable
When the data will become available and for how long
Start the access period 6 months after printing the results
To whom data/document is available
Only for researchers working in academic and scientific institutions
Under which criteria data/document could be used
Meta analysis
From where data/document is obtainable
Dr Nazila Javadi, Guilan University of Medical Sciences, Shahid Beheshti Nursing and Midwifery School of Rasht
What processes are involved for a request to access data/document