Protocol summary

Summary
This clinical trial study will do to assess the effect of light pressure stroking massage with sesame (Sesamum indicum) oil and olive oil on pain severity and amount of received analgesic in patients with upper or lower limbs trauma. Main inclusion criteria include passing at least 1 hours and at last 6 hours from trauma; lack of infection, bone fractures, dislocation, amputation, nerve damage, presence of a foreign body and internal or external bleeding; lack of cast or splint at trauma site, having appropriate perfusion in trauma site; having moderate pain during arrival time (obtaining score between 3-6 based on visual analog scale). Exclusion criteria include refusing to referral to recruitment centers for follow up more than two times consecutively; any sing of allergy and complication in patients during the study. Patients will allocate to three equal groups of light pressure stroking massage alone, light pressure stroking massage with sesame (Sesamum indicum) oil and light pressure stroking massage with olive oil according to according to table of random numbers. We will ask patients in three groups to irrigate and clean the trauma site with normal saline solution (0.9%), and after drying it with a sterile gaze, message the trauma site for 5 minutes through light pressure stroking method alone, light pressure stroking with sesame (Sesamum indicum) oil and light pressure stroking with olive oil. Intervention will do twice a day with 12 hours interval until 9 days in three groups and at the first, 3rd, 6th and 9th days of intervention, the pain severity and amount of received analgesic will assess by co-researcher.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015082814251N4
Registration date: 2015-09-19, 1394/06/28
Registration timing: prospective

Last update:
Update count: 0
Registration date
2015-09-19, 1394/06/28
Registrant information
Name
MORTEZA NASIRI
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 77 2622 5292
Email address
nasiri.m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Aja University of Medical Sciences
Expected recruitment start date
2015-09-23, 1394/07/01
Expected recruitment end date
2016-05-21, 1395/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of light pressure stroking massage with placebo, with sesame (Sesamum indicum) oil and olive oil on pain severity and amount of received analgesic in patients with upper or lower limbs trauma
Public title
Effect of light pressure stroking massage with placebo, sesame (Sesamum indicum) oil and olive oil on pain severity and amount of received analgesic in patients with trauma
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: age range of 15-50 years old; full consciousness and being able to read and write, passing at least 1 hours and at last 6 hours from trauma; lack of infection, bone fractures, dislocation, amputation, nerve damage, presence of a foreign body and internal or external bleeding; lack of cast or splint at trauma site, having appropriate perfusion in trauma site; free from diabetes, cardiovascular, musculoskeletal diseases and peptic ulcers; not receiving anti-coagulant drugs in 3 months ago; lack of sensitivity or allergy to the oils plant group; lack of addiction and cigarette smoking; having moderate pain during arrival time (obtaining score between 3-6 based on visual analog scale). Exclusion criteria: refusing to referral to recruitment centers for follow up more than two times consecutively; any sing of allergy and complication in patients during the study.
Age
From 15 years old to 50 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)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Aja University of Medical Sciences Ethics Committee
Street address
Aja University of Medical Sciences, Etemadzadeh street, West Fatemi street, Tehran, Iran.
City
Tehran
Postal code
Approval date
2015-08-10, 1394/05/19
Ethics committee reference number
IR.AJAUMS.REC.1394.22

Health conditions studied

1

Description of health condition studied
Pain
ICD-10 code
R52.0
ICD-10 code description
Acute pain

Primary outcomes

1

Description
Pain
Timepoint
At first, third, sixth and ninth days of intervention
Method of measurement
Pain assessment scale

Secondary outcomes

1

Description
Amount of received analgesic
Timepoint
At first, third, sixth and ninth days of intervention
Method of measurement
Pain assessment checklist

Intervention groups

1

Description
We will ask patients in first intervention group to message trauma site for 5 minutes through light pressure stroking method with olive oil.
Category
Other

2

Description
We will ask patients in second intervention group to message trauma site for 5 minutes through light pressure stroking method with sesame (Sesamum indicum) oil.
Category
Other

3

Description
We will ask patients in control group to message trauma site with placebo for 5 minutes through light pressure stroking method.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Busheher Amir-Al Momanin Hospital
Full name of responsible person
Street address
City
Busheher

2

Recruitment center
Name of recruitment center
Busheher Khatem-Al Anbia Hospital
Full name of responsible person
Street address
City
Busheher

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vic-chancellor of research and technology of Aja University of Medical Sciences
Full name of responsible person
Dr, Kamran Azma
Street address
Aja University of Medical Sciences, Etemadzadeh street, West Fatemi street,Tehran, Iran.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vic-chancellor of research and technology of Aja 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
Faculty of Nursing, Aja University of Medical Sciences, Tehran, Iran.
Full name of responsible person
Zahra Farsi
Position
P.H.D of nursing education
Other areas of specialty/work
Street address
Faculty of Nursing, Aja University of Medical Sciences, Kaj street,Tehran, Iran.
City
Tehran
Postal code
Phone
+98 21 8833 7920
Fax
Email
zahrafarsi@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Faculty of Nursing, Aja University of Medical Sciences, Tehran, Iran.
Full name of responsible person
Zahra Farsi
Position
P.H.D of nursing education
Other areas of specialty/work
Street address
Faculty of Nursing, Aja University of Medical Sciences, Kaj street,Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 8833 7920
Fax
Email
zahrafarsi@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Aja University of Medical Science
Full name of responsible person
Morteza Nasiri
Position
MSc of nursing education
Other areas of specialty/work
Street address
Aja University of Medical Science, Etemadzadeh street, West Fatemi street, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 8833 7920
Fax
Email
mortezanasiri.or87@yahoo.com
Web page address

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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