Determining the effect of basil oil on the severity of low back pain in patients after coronary artery angioplasty
Design
The third phase of the clinical trial with a control group with parallel group design, which will be implemented by random allocation method with blocks classified by sex and age (25 to 44 years and 45 to 64 years) with the 64 sample.
Settings and conduct
This study will be performed in the angioplasty department of Al-Zahra Hospital in Sari city.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Non-emergency angioplasty candidate through femoral, Age between 25 and 64 years, Body mass index between 25-29/9, No known previous history of skin allergies, Lack of low back pain before angioplasty, Get a pain score of at least 3 after three hours of angioplasty with visual Analogue Scale
Exclusion criteria:Receiving analgesic for any reason during the intervention,Occurrence of active hemorrhage during angioplasty
Intervention groups
Intervention group: A number of patients eligible to enter the study. Control group: A number of patients eligible to enter the study equal to the intervention group, which will be determined based on the Pilot study.
The intervention, involves the use of two milliliters of the Basil oil made by Arterina company, will be poured to the 10 by 10 centimeter sterile gas and fix to the lumbar region with a glue.
For the control group, two milliliters of Lubricant gel, is poured on a piece of 10 by 10 centimeter sterile gauze and fix to the lumbar region with a glue.
Main outcome variables
Low back pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140721018550N9
Registration date:2020-05-10, 1399/02/21
Registration timing:prospective
Last update:2020-05-10, 1399/02/21
Update count:0
Registration date
2020-05-10, 1399/02/21
Registrant information
Name
Nayyereh Raiesdana
Name of organization / entity
Semnan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 3345 3867
Email address
nr_dana@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-21, 1399/04/01
Expected recruitment end date
2020-10-22, 1399/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Basil (Ocimum basilicum L.) Oil on Severity of Low back pain of patients after coronary angioplasty
Public title
The effect of Basil Oil on Severity of Low back pain
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Non-emergency angioplasty candidate through femoral
Age between 25 and 64 years
Body mass index between 25-29/9
No known previous history of skin allergies
Lack of low back pain before angioplasty
Get a Low back pain score of at least 3 after three hours of angioplasty with visual Analogue Scale
Exclusion criteria:
Receive analgesic for any reason during the intervention
Occurrence of active hemorrhage during angioplasty
Age
From 25 years old to 64 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
We first assign four subgroups (stratum): 1 - Women 25 to 44 years 2 - Men 25 to 44 years 3 - Women 45 to 64 years 4 - Men 45 to 64 years old Each patient enrolled in the study is placed in one of these four groups. Then, using the randomized random list for each stratum (4 predefined lists), that person is in the intervention group A or control B. To create the desired list of 6 possible blocks, we assign quadrants to each numerical block (from I to VI): According to the random numbers table, numbers 1 through 6 correspond to the above blocks and do not count numbers 7 to 9 and 0. Random numbers are generated with Excel. Then the assignment list (from left to right) is determined for each stratum.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Semnan University of Medical Sciences
Street address
Nursing and Midwifery colledge, Semnan University of Medical Sciences, Kilometer5 Damghan road, Semnan, Iran
City
Semnan
Province
Semnan
Postal code
3513138111
Approval date
2020-03-10, 1398/12/20
Ethics committee reference number
IR.SEMUMS.REC.1399.012
Health conditions studied
1
Description of health condition studied
Low back pain after Coronary angioplasty
ICD-10 code
M54.5
ICD-10 code description
Low back Pain
Primary outcomes
1
Description
Low back pain
Timepoint
Three hour after angioplasty and 3 and 6 hour after intervention
Method of measurement
Visual analogue Scale(VAS)
Secondary outcomes
1
Description
Blood pressure
Timepoint
Three hours after angioplasty and three and six hour after intervention
Method of measurement
Digital Sphygmomanometer
2
Description
Pulse Rate
Timepoint
Three hours after angioplasty and three and six hour after intervention
Method of measurement
Saadat Monitoring
Intervention groups
1
Description
Intervention group:At first, the demographic information questionnaire is completed and then the low back pain is measured with a pain visual analogue scale, and their blood pressure and pulse rate are measured and recorded with the same digital device in the supine position.After that, two milliliters of basil oil is poured on a piece of gas and glued with a wicker glue in the lumbar region. Then, at intervals of 3 and 6 hours after the intervention, the severity of low back pain is measured with a pain visual analogue scale and blood pressure and pulse rate in both stages from the same arm and in the supine position measured and recorded.
Category
Other
2
Description
Control group:َAt first, the demographic information questionnaire is completed and then the low back pain is measured with a pain visual analogue scale, and their blood pressure and pulse rate are measured and recorded with the same digital device in the supine position. After that, two milliliters of lubricant gel is poured on a piece of gas and glued with a wicker glue in the lumbar region. Then, at intervals of 3 and 6 hours after the intervention, the severity of low back pain is measured with a pain visual analogue scale and blood pressure and pulse rate in both stages from the same arm and in the supine position measured and recorded.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemeh Al-Zahra hospital affiliated to Mazandaran University of Medical sciences