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The effects of light pressure stroking massage with olive oil placebo on pain severity and dose of received analgesic in patients with upper or lower limbs trauma

Protocol summary

Study aim
Comparison the effect of light pressure stroking massage with olive oil and placebo on pain severity and dose of received analgesic in patients with upper or lower limbs trauma
Design
In this research, 60 eligible patients referring to Tehran Beasat Hospital will be selected with consecutive sampling method. Patients will be randomly allocated to two equal groups of massage with olive oil and placebo using sealed envelopes.
Settings and conduct
This study will be conducted on Tehran Beasat Hospital. Patients, outcomes assessor, and care provider will be blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age range of 15 to 50 years; being fully conscious and having the ability to read and write in Persian; presence of one limbs trauma which passed a maximum of six hours and at least one hour of its initiation; experience of regional and moderate pain on the trauma site based on the visual analog scale (obtaining a score of four to seven) during the admission time. Exclusion criteria: any infections, bone fractures, internal and external bleedings, dislocations, amputations, and nerve damages on the affected limb during the admission time; having confirmed deep vein thrombosis; taking anti-coagulants, analgesics, tranquilizers or sedatives, and any topical herbal extracts in the past three months; absence of cast or splint on the trauma site; having history of diabetes, cardiovascular diseases, musculoskeletal disorders, gastrointestinal bleedings, allergic reactions to any herbal extracts, and addiction to drugs or alcohol.
Intervention groups
Trauma site will be massaged through light pressure stroking method with olive oil in the intervention group and with placebo in the control group twice a day for nine consecutive days.
Main outcome variables
Pain severity and dose of received analgesic

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20130803014251N8
Registration date: 2019-01-21, 1397/11/01
Registration timing: registered_while_recruiting

Last update: 2019-01-21, 1397/11/01
Update count: 0
Registration date
2019-01-21, 1397/11/01
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
Expected recruitment start date
2019-01-05, 1397/10/15
Expected recruitment end date
2019-10-22, 1398/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of light pressure stroking massage with olive oil placebo on pain severity and dose of received analgesic in patients with upper or lower limbs trauma
Public title
effects of massage on pain in traumatic patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age range of 15 to 50 years Being fully conscious and having the ability to read and write in Persian Presence of one limbs trauma which passed a maximum of six hours and at least one hour of its initiation Experience of regional and moderate pain on the trauma site based on visual analog scale (obtaining score of 4 to 7) during the admission time confirmation of appropriate perfusion on the trauma site by a physician
Exclusion criteria:
Having infections, bone fractures, dislocations, internal and external bleedings, amputations, and nerve damages on the trauma site during the admission time Having cast or splint on the trauma site Having deep vein thrombosis confirmed by a physician Having diabetes, cardiovascular and musculoskeletal diseases, and gastrointestinal bleedings Taking anti-coagulants, analgesics, tranquilizers or sedatives, and any topical herbal extracts in the past three month History of allergic reactions to any herbal extracts History of addiction, cigarette, and alcohol abuse
Age
From 15 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
  • Outcome assessor
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
The eligible patients will allocate to olive oil group or placebo group using simple randomization method by sealed envelopes.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patients and the nursing staff, who will perform the interventions, will be blinded to the contents of the bottles. Moreover, all assessments and scorings in the two groups will done by a nurse, who will not aware of group assignments.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Aja University of Medical Sciences
Street address
Aja University of Medical Sciences, Etemadzadeh street, West Fatemi street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1411718541
Approval date
2018-12-09, 1397/09/18
Ethics committee reference number
IR.AJAUMS.REC.1397.055

Health conditions studied

1

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

Primary outcomes

1

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

2

Description
Dose of received analgesic
Timepoint
At first and ninth days of intervention
Method of measurement
Pain assessment checklist

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The patients in the olive oil group will receive massage with olive oil twice a day for nine consecutive days. For each time, 10 mL of olive oil will apply on the site of trauma for each 50 cm2 and then the trauma site will massage for five minutes.
Category
Treatment - Other

2

Description
Control group: The patients in the placebo group will receive massage with liquid paraffin twice a day for nine consecutive days. For each time, 10 mL of placebo will apply on the site of trauma for each 50 cm2 and then the trauma site will massage for five minutes.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Besat Nahaja Hospital
Full name of responsible person
Zahra Farsi
Street address
Basij Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 3321 6512
Email
zahrafarsi@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Dr Mostafa Shahrezaee
Street address
Aja University of Medical Sciences, Etemadzadeh street, West Fatemi street,Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 8609 6350
Email
moshahrezayee@yahoo.com
Grant name
Not applicable
Grant code / Reference number
25069
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Artesh 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
Shiraz University of Medical Sciences
Full name of responsible person
Morteza Nasiri
Position
Student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery (SA), Namazi Square, Shiraz, Iran.
City
Shiraz
Province
Fars
Postal code
71936-13119
Phone
+98 71 3647 4254
Fax
+98 71 3647 4252
Email
mortezanasiri.or87@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Morteza Nasiri
Position
Student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery (SA), Namazi Square, Shiraz, Iran.
City
Shiraz
Province
Fars
Postal code
71936-13119
Phone
+98 71 3647 4254
Email
mortezanasiri.or87@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Morteza Nasiri
Position
Student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery (SA), Namazi Square, Shiraz, Iran.
City
Shiraz
Province
Fars
Postal code
71936-13119
Phone
+98 71 3647 4254
Email
mortezanasiri.or87@yahoo.com

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
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Only a part of patients demographical data and main outcomes will be shared.
When the data will become available and for how long
Six months after data publishing
To whom data/document is available
Data will be available only for researchers working on academic and university associations
Under which criteria data/document could be used
Mention of study name Mention of authors name
From where data/document is obtainable
Zahra Farsi: School of Nursing, AJA University of Medical Sciences, Tehran, Iran
What processes are involved for a request to access data/document
At last one month after request
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