The comparison of local camomille product oil and sesame oil on employed nurses chronic low back pain at hospital.
Design
randomized double- blind clinical trial
Settings and conduct
At the first intervention group, by the researcher, anointment with the camomille oil and without deep massage will be used on the back and at the place of the pain. Also at the second intervention group, anointment with sesame oil on the back wil be used and by the researcher massage is given gentley with the palm. At the each group, the duration of the intervention will be 3 weeks, twice a day. For men, scholar help will be used.
Rajaee and Ghaem hospitals at Alborz will be the location of the study.
Participants/Inclusion and exclusion criteria
nursing grades , 25 to 60 years old; not having spondylosis, lordosis, kyphosis, scoliosis, scoliosis; not having malignancy in spine; nursing with chronic pain in back more than 12 weeks; not using analgesic drugs regularly; not using analgesic oils regularly; nursing that are not under treated with medications, physiotherapy, reformative exercises, hydrotherapy; no history of spine surgery. Major exclusion criteria: unwillingness in participating at study; not participating at study more than 2 days; pregnancy.
Intervention groups
first intervetion(anointment with camomille product oil) and second intervention(anointment with sesame oil)
Main outcome variables
pain intensity will be that before the intervention and at the end of the first, second, third and fourth week will be assessed.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170812035634N1
Registration date:2018-01-08, 1396/10/18
Registration timing:retrospective
Last update:2018-01-08, 1396/10/18
Update count:0
Registration date
2018-01-08, 1396/10/18
Registrant information
Name
Mina Abolfazlie
Name of organization / entity
Faculty of Nursing and Midwifery,Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6692 7171
Email address
m-abolfazli@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran university of medical sciences
faculty of nursing and midwifery
Expected recruitment start date
2017-09-11, 1396/06/20
Expected recruitment end date
2017-12-11, 1396/09/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of local camomille product oil and sesame oil on nurses chronic low back pain
Public title
The comparison of local camomille product oil and sesame oil on nurses chronic low back pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
nursing grades , 25 to 60 years old;
not having spondylosis, lordosis, kyphosis, scoliosis;
not having malignancy in spine;
nursing with chronic pain in back more than 12 weeks;
not using analgesic drugs regularly;
not using analgesic oils regularly;
nursing that are not under treated with medications, physiotherapy, reformative exercises, hydrotherapy;
no history of spine surgery.
Exclusion criteria:
unwillingness in participating at study;
not participating at study more than 2 days;
pregnancy.
Age
From 25 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
74
Randomization (investigator's opinion)
Randomized
Randomization description
Samples will be selected by simple random sampling method from all wards of the hospital and will be divided to two groups as the first and second intervention groups. Then the design of permutation blocks will be done. That way, A letter for the first group intervention and B letter for the second group intervention will be considered. AB, for digits from 0 to 4, and BA from digits from 5 to 9 will be considered. According to sortition, if the first person will be from 0 to 4 digits will stand in the first intervention group and the next person will be in the second group intervention. If the first person will be from 5 to 9 digits will stand in the second group and the next person wil be in the first group intervention. Thus, sortition will be done for 74 samples by 37 times.
Blinding (investigator's opinion)
Double blinded
Blinding description
The researcher and the samples will not know the content of the oils and also the basis of the two oils will be the same, as the result those are similar in the appearance, smell and color.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethicsl Commitee of Tehran Faculty of Nursing and Midwifery and rehabilitation
Street address
Faculty of Nursing and Midwifery, Nosrat Sharghi Street, Tohid Square, Tehran
City
Tehran
Province
Tehran
Postal code
1419733171
Approval date
2017-01-03, 1395/10/14
Ethics committee reference number
IR.TUMS.FNM.REC.1395.1396
Health conditions studied
1
Description of health condition studied
low back pain
ICD-10 code
m00-m99
ICD-10 code description
Diseases of the musculoskeletal system and connective tissue
Primary outcomes
1
Description
Treatment Satisfaction
Timepoint
After lntervention
Method of measurement
Global scale of relieve pain satisfaction
2
Description
Absenteeism
Timepoint
Two months before intervention, Two months after intervention
Method of measurement
Questionnaire
3
Description
Pain
Timepoint
Before Intervention, At the end of the first, Second, Third week, One week after intervention
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
At the first intervention group, camomille product oil will be used in the area where pain occurs for 3 weeks twice a day. By the way that the oil is placed on the skin surface with the palm and without the deep pressure and the oil cover the intended are
Category
Treatment - Drugs
2
Description
The sesame oil will be used for the second intervention group, By the way that the sesame oil will be placed at the back and the area that there is pain and the arounds with the palm, without deep massage. The minimum amount of the oil that will be used i
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem hospital
Full name of responsible person
Mina abolfazlie
Street address
Dolatabad Intersection, Karaj, Alborz
City
karaj
Province
Alborz
Postal code
1419733171
Phone
+98 21 6692 7171
Email
m.abolfazlie@yahoomail.com
2
Recruitment center
Name of recruitment center
Rajaee Hospital
Full name of responsible person
Mina abolfazlie
Street address
Hesarak street, Karaj, Alborz
City
karaj
Province
Alborz
Postal code
1419733171
Phone
+98 21 6692 7171
Email
m.abolfazlie@yahoomail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Masood Younesian
Street address
Central building of Tehran University of Medical Sciences, Qhds street, Keshavarz Blvd
City
Tehran
Province
Alborz
Postal code
1419733171
Phone
+98 21 6692 7171
Email
m.abolfazlie@yahoomail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Mina abolfazlie ghamsari
Position
Master of Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Nosrat Sharghi Street, Tohid Square, Tehran
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Fax
Email
m.abolfazlie@yahoomail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mina abolfazlie ghamsari
Position
Master of Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Nosrat Sharghi Street, Tohid Square, Tehran
City
Tehran
Province
Alborz
Postal code
1419733171
Phone
+98 21 6692 7171
Fax
Email
m.abolfazlie@yahoomail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mina abolfazlie ghamsari
Position
master of nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Nosrat Sharghi Street, Tohid Square
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Fax
Email
m.abolfazlie@yahoomail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available