Comparison of the effect of Rosemary essential oil and Comfrey ointment on the severity of pain and bruising caused by enoxaparin injection in cardiac patients
Comparison of the effect of rosemary essential oil and comfrey ointment on the severity of pain and bruising caused by enoxaparin injection in cardiac patients.
Design
A clinical trial that will be conducted on heart patients hospitalized in Ferdous hospitals in 1402. 120 people will be selected by the available method and will be randomly allocated in 3 groups: rosemary essential oil intervention, comfrey ointment intervention and comparison.
Settings and conduct
The study population includes all cardiac patients admitted to Hazrat Rasool and Shahid Chamran Hospital in Ferdous city, for whom Enoxaparin was prescribed.
Participants/Inclusion and exclusion criteria
Entry: at least one of the types of heart diseases and receiving enoxaparin as a treatment for them, complete alertness, minimum literacy for counting numbers, not receiving medication at the same time as subcutaneous injection
Intervention groups
3 puffs of rosemary essential oil (rosemary essential oil made by Ganjineh Esara Nabarat pharmaceutical company) will be applied 5 minutes before enoxaparin injection at the needle entry site.
Comfrey ointment made by Vesha Daru Pars herbal pharmaceutical company with health code (8417259867917335) 1.5 grams will be used topically 60 minutes before injection.
Main outcome variables
Severity of pain and bruising
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240430061604N1
Registration date:2024-07-02, 1403/04/12
Registration timing:registered_while_recruiting
Last update:2024-07-02, 1403/04/12
Update count:0
Registration date
2024-07-02, 1403/04/12
Registrant information
Name
maryam mokhtariseghaleh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 56 3289 3005
Email address
maryammoktari3ghale@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-17, 1403/03/28
Expected recruitment end date
2024-10-19, 1403/07/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of Rosemary essential oil and Comfrey ointment on the severity of pain and bruising caused by enoxaparin injection in cardiac patients
Public title
: Comparison of the effect of Rosemary essential oil and Comfrey ointment on the severity of pain and bruising caused by enoxaparin injection in cardiac patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Full consciousness
Minimum literacy for counting numbers
Not receiving medication at the same time with subcutaneous injection
Exclusion criteria:
Death of the patient
discharge before 48 hours
receipt of intravenous anticoagulant for any reason
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blocks will be randomly allocated in three groups: intervention of rosemary essential oil, intervention of comfrey ointment and control.
Blocked randomization is for the purpose of making sure that exactly equal number of participants are included in the intervention and control group at consecutive but equal time intervals. The size of each block can be 5, 10, 16 to 20 people. In this way, for example, one type of treatment is given to the first block and another type to the second, and again the first type to the third block and so on.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Birjand Medical Sciences
Street address
Ghaffari St
City
Birjand
Province
South Khorasan
Postal code
97891143963
Approval date
2024-06-10, 1403/03/21
Ethics committee reference number
IR.BUMS.REC.1403.077
Health conditions studied
1
Description of health condition studied
Acute coronary syndrome
ICD-10 code
I24.9
ICD-10 code description
Acute ischemic heart disease, unspecified
Primary outcomes
1
Description
Severity of pain and bruising
Timepoint
Pain intensity immediately after injection and 5 minutes after injection
Method of measurement
Using visual pain scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Rosemary essential oil intervention, 3 puffs of rosemary essential oil (rosemary essential oil made by Ganjineh Asara Nabarat Pharmaceutical Company) will be applied 5 minutes before enoxaparin injection at the injection site. After 5 minutes, the injection site will be disinfected with alcohol.
Category
Prevention
2
Description
Intervention group: Comfrey ointment made by Vesha Daru Pars herbal pharmaceutical company with health code (8417259867917335) 1.5 grams will be used topically 60 minutes before injection and the amount of bruising will be measured using a standard ruler 24 and 48 hours later. And for the comparison group, routine ward treatments are performed.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Hazrat Rasool and Martyr Chamran Hospital in Firdous city
Full name of responsible person
Maryam Mokhtari SeGhale
Street address
Motehari street
City
Ferdous
Province
South Khorasan
Postal code
9789143963
Phone
+98 56 3162 7300
Email
maryammoktari3ghale@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Hossein Safarpour
Street address
Ghaffari St., Birjand University of Medical Sciences, Research Assistant
City
Birjand
Province
South Khorasan
Postal code
9789143963
Phone
+98 56 3238 1230
Email
h.safarpour@bums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand 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
Birjand University of Medical Sciences
Full name of responsible person
Maryam Mokhtari Se Ghale
Position
nurse
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Madani 17-plate 12
City
Ferdows
Province
South Khorasan
Postal code
9789143963
Phone
+98 56 3289 3005
Email
maryammoktari3ghale@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Maryam Mokhtari Se Ghale
Position
Nurse
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Madani 17-plate 12
City
Ferdows
Province
South Khorasan
Postal code
9789143963
Phone
005632893005
Email
maryammoktari3ghale@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Maryam Mokhtari Se Ghale
Position
Nurse
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Madani 17-plate 12
City
Ferdows
Province
South Khorasan
Postal code
9789143963
Phone
+98 56 3289 3005
Email
maryammoktari3ghale@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD