Comparison the effect of aromatherapy with lavender and rose essence on the prevention headache due to Nitroglycerine infusion in patient admitted to cardiac care unite
Comparison the Effect of Lavender and rose essence on the prevention headache due to Nitroglycerine in Patients admitted to ccu
Design
A randomized controlled clinical trial with parallel and groups, not blinded, was randomized
Settings and conduct
in the intervention group of lavender and rose, at the same time as the infusion of nitroglycerin, aromatherapy with cotton soaked in 3 drops of lavender and rose will be performed for half an hour.No aromatherapy will be used in the control group.Using the VAS pain scale, the severity and frequency of headaches will be measured at 15, 30, 60, 90 minutes after aromatherapy. In case of pain in each group, routine treatment of headache, 325 mg acetaminophen tablets will be used and will be recorded in the patient questionnaire.The instruments used in this study are Patient Profile Questionnaire and VAS Pain Scale Questionnaire.Study population: Patients admitted to the cardiac care unit of Hospital Allameh Bohlool Gonabadi
Participants/Inclusion and exclusion criteria
Willingness to participate in the study;Age range from 70to30 years;Awareness of time and place and people;Having a doctor's order to get infused nitroglycerin;No headache before infusion of nitroglycerin;No history of allergies to any herbal medicine;No olfactory disorder and colds and nasal congestion;No analgesics before the start of infusion nitroglycerin;No history of respiratory problems;No pregnancy;No history of drug addiction
Intervention groups
In the intervention group of lavender and rose, at the same time as the infusion of nitroglycerin, aromatherapy with cotton soaked in 3 drops of lavender and rose will be performed for half an hour.No aromatherapy will be used in the control group.
Main outcome variables
Aromatherapy; Headache severity; Headache incidence; Age; Gender Education; Height; Weight; Marriage; History of hospitalization; Incidence of
angina
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190715044221N1
Registration date:2019-10-16, 1398/07/24
Registration timing:prospective
Last update:2019-10-16, 1398/07/24
Update count:0
Registration date
2019-10-16, 1398/07/24
Registrant information
Name
Fereshte Jalili
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5722 0604
Email address
f.jalili1826@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-23, 1398/08/01
Expected recruitment end date
2019-12-22, 1398/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of aromatherapy with lavender and rose essence on the prevention headache due to Nitroglycerine infusion in patient admitted to cardiac care unite
Public title
Comparison the effect of aromatherapy with lavender and rose essence on the prevention headache due to Nitroglycerine infusion
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to participate in the study
Age range from 30to 70 years
Awareness of time and place and people
Having a doctor's order to get infused nitroglycerin
No headache before infusion of Nitroglycerin
No history of allergies to any herbal medicin
No olfactory disorder and colds and nasal congestion
No analgesics before infusion of Nitroglycerin
No history of respiratory problems
No pregnancy
Do not use perfume or cologne during aromatherapy
No history of drug addiction
Exclusion criteria:
Not willing to continue cooperation
Allergic to lavender and roses during the study
Age
From 30 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
42
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, the research units will be selected by available method and will be randomly assigned by permutation blocks with 3 blocks in three groups (Lavender and Rose and control).
The 6 possible modes for the blocks are as follows: ABC, BAC, CAB, ACB, BCA, CBA. Each block will be assigned a number between one and six, and will then be assigned to the control group (A), lavender (B), and rose (C) based on the block corresponding to the number selected. This will continue until the sample size (14 blocks) is complete.
In this study, the randomization tool is a random number table.
Blinding (investigator's opinion)
Single blinded
Blinding description
Clinical participants and caregivers, are not aware of the intervention type.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Gonabad University of Medical sciences
Street address
Santo Road
City
gonabad
Province
Razavi Khorasan
Postal code
9691797852
Approval date
2019-05-13, 1398/02/23
Ethics committee reference number
IR.GMU.REC.1398.061
Health conditions studied
1
Description of health condition studied
Headache in heart patients
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Headache caused by infusion of nitroglycerin
Timepoint
Frequency and severity of headache 15, 30, 60 and 90 minutes after nitroglycerin infusion
Method of measurement
Visual Analogue Scale
Secondary outcomes
1
Description
Frequency and severity of angina
Timepoint
15, 30, 60 and 90 minutes after starting aromatherapy
Method of measurement
Visual Analogue Scale
Intervention groups
1
Description
Intervention group: Lavender group: In this group, at the same time as the infusion of nitroglycerin, aromatherapy with cotton impregnated with three drops of 20% lavender essential oil will be performed for half an hour.
Category
Prevention
2
Description
Intervention group:Rose group: In this group, at the same time as the infusion of nitroglycerin, the aromatherapy with cotton soaked in three drops of rose essential oil 40% made by Gorgan Company will take half an hour.
Category
Prevention
3
Description
Control group: No perfume will be given at the same time as nitroglycerin infusion is started.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Bohlool hospital
Full name of responsible person
Kokab basiri moghadam
Street address
Parastar Blvd,Bohlool hospital
City
Gonabad
Province
Razavi Khorasan
Postal code
9691797852
Phone
+98 51 5723 6833
Fax
+98 51 5723 6160
Email
f.jalili1826@gmail.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
SHahla KHosravan
Street address
sento road
City
gonabad
Province
Razavi Khorasan
Postal code
9691797852
Phone
+98 51 5722 3028
Email
f.jalili1826@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gonabad 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
Gonabad University of Medical Sciences
Full name of responsible person
fereshte jalili
Position
nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Nurse Blvd, Bohlool hospital
City
gonabad
Province
Razavi Khorasan
Postal code
9691797852
Phone
+98 51 5723 6833
Email
f.jalili1826@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
kokab basiri moghadam
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
sento road,Gonabad university of medical siences
City
gonabad
Province
Razavi Khorasan
Postal code
9691797852
Phone
+98 51 5722 3028
Email
k.basiri@gmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
fereshte jalili
Position
Nursing Graduate Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
parastar Blvd,Bohlool hospital
City
gonabad
Province
Razavi Khorasan
Postal code
96917-97852
Phone
+98 51 5723 6833
Email
f.jalili1826@gmail.com
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