Comparison the effect of aromatherapy with Lavender essential oil versus Acetaminophen tablet on Nitroglycerin-induced headache and comfort in the patients with angina pectoris in Cardiac Care Units
Comparison the effect of aromatherapy with Lavender essential oil versus Acetaminophen tablet on Nitroglycerin-induced headache and comfort in the patients with angina pectoris in Cardiac Care Units
Design
Clinical trial with randomized control group
Settings and conduct
Cardiac Care Units affiliated to Hamedan University of Medical Sciences in three groups (Acetaminophen, Lavender essential oil and control)
Patients' headache was assessed in all three groups with the standard scale of pain assessment (VAS)
Evaluating the comfort of patients in all three groups was the standard scale of comfort assessment (VAS)
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age 30-60 years; receiving Nitroglycerin infusion for the first time; receiving acetaminophen PRN; Not having a history of a migraine or a chronic headache
Exclusion criteria:
Hypotension; Drug hypersensitivity
Intervention groups
1. The Acetaminophen group: Oral Acetaminophen (500 mg of a product from a prestigious company) that is having order in the form of PRN, which is given to the patient 15 minutes before infusion of Nitroglycerin.
2. Lavender essential oil group: In this group, cotton dusted with 3 drops of 2% non-fatty lavender essential oil prepared from a prestigious company, 15 minutes before the onset of nitroglycerin infusion, is attached to the collar and is Inhalated by the patient.
3. Control group: This group of patients will receive only common care, and ََAcetaminophen and Lavender essential oil will not be given as a preventive intervention.
Main outcome variables
Prevention of Nitroglycerin headaches
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180927041157N1
Registration date:2018-11-10, 1397/08/19
Registration timing:registered_while_recruiting
Last update:2018-11-10, 1397/08/19
Update count:0
Registration date
2018-11-10, 1397/08/19
Registrant information
Name
Roghayeh Ezati-Soleaman
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3262 1123
Email address
r.ezati@edu.umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-23, 1397/08/01
Expected recruitment end date
2019-01-21, 1397/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of aromatherapy with Lavender essential oil versus Acetaminophen tablet on Nitroglycerin-induced headache and comfort in the patients with angina pectoris in Cardiac Care Units
Public title
Comparison effect of Lavender and Acetaminophen on Nitroglycerin-induced headache
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Receiving Nitroglycerin infusion for the first time
Receiving Acetaminophen PRN
Not having a history of sublingual Nitroglycerin use
Not having a history of migraine or chronic headaches
No sensitivity to Acetaminophen
No sensitivity to medicinal Plants
Lack of olfactory disorders
Ability to swallow
Ability to speak
Exclusion criteria:
Hypotension
Drug susceptibility
Age
From 30 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Samples will be selected by simple sampling method and in the form of permutable blocks ABC-ACB -BCA -BAC -CAB -CAB is randomly assigned to three groups (Acetaminophen, Lavender essential oil and control).
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Hamedan University of Medical Sciences
Street address
Besat Hospital
City
Hamedan
Province
Hamadan
Postal code
6514887467
Approval date
2018-09-01, 1397/06/10
Ethics committee reference number
IR.UMSHA.REC.1397.409
Health conditions studied
1
Description of health condition studied
Angina
ICD-10 code
I20-I25
ICD-10 code description
Ischaemic heart diseases
Primary outcomes
1
Description
Pain scale by VAS scale
Timepoint
The evaluation of the patient's headache at 5, 10, 15, and 60 minutes after the onset of Nitroglycerine infusion
Method of measurement
The evaluation of the patient's headache in three groups (Acetaminophen, Lavender essential oil and control) at 5, 10, 15, and 60 minutes after the onset of Nitroglycerine infusion will be measured.
2
Description
Comfort scale by VAS scale
Timepoint
The evaluation of the patient's comfort 15 minutes before infusion and at 60 minutes after initiation of nitroglycerin infusion
Method of measurement
The evaluation of the patient's comfort (VAS) 15 minutes before infusion and at 60 minutes after initiation of nitroglycerin infusion in three groups (acetaminophen, lavender essential oil and control) will be measured.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention Group: The Acetaminophen Group: Oral Acetaminophen (500 mg) of the Alborz Drug Company is prescribed by the physician as needed(PRN), which is given to a patient 15 minutes prior to the onset of nitroglycerin infusion.
Category
Prevention
2
Description
Intervention group: Lavender group: In this group, cotton dusted with 3 drops of 2% non-fatty lavender essential oil prepared from, Tabib Medical Company 15 minutes before the onset of nitroglycerin infusion, is attached to the collar and will be washed by the patient.
Category
Prevention
3
Description
Control group: Only common care will be taken to treat headache caused by nitroglycerin infusion.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat hospital and Farshchian heart hospital
Full name of responsible person
Roghayeh Ezati-soleaman
Street address
Besat hospital
City
Hamedan
Province
Hamadan
Postal code
6514887467
Phone
+98 81 3262 1123
Email
r.ezati@edu.umsha.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Research and Technology Vice-Chancellor
Street address
In front of Mardom Park
City
Hamadan
Province
Hamadan
Postal code
65178-38678
Phone
+98 81 3838 0717
Email
internationalaffairs@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
َArezo Karamporian
Position
Teacher
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Hamedan university of medical sciences
City
Hamedan
Province
Hamadan
Postal code
6514887467
Phone
+98 81 3262 1123
Email
a.karampourian@umsha.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
َArezo Karamporian
Position
Teacher
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Hamedan university of medical sciences
City
Hamedan
Province
Hamadan
Postal code
6514887467
Phone
+98 81 3262 1123
Email
a.karampourian@umsha.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Roghayeh ezati soleiman
Position
Nursing student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Besat Hospital
City
Hamedan
Province
Hamadan
Postal code
6514887467
Phone
+98 81 3262 1123
Email
r.ezati@edu.umsha.ac.ir
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
Yes - There is a plan to make this available
Title and more details about the data/document
The total data after unidentifiable participants can be shared.
When the data will become available and for how long
After the end of the study
To whom data/document is available
Researchers working in academic centers
Under which criteria data/document could be used
For the treatment of patients
From where data/document is obtainable
Email address
What processes are involved for a request to access data/document
Requesting information is possible through the author's email at the end of the study.