Protocol summary

Summary
Objective: Comparison of lavender and Rosa Damascena scents on anxiety and vital signs of patients under coronary artery Angiography. Design: A clinical trial, single-center, randomized (block). How do: study in four groups: lavender, damask rose, placebo and control is performed. In this single-blind study, patients and the analyzed individual who does not have the kind of intervention. Inclusion criteria: age 35-70 years, alert, a healthy sense of smell; no drugs, anti-anxiety and depression in the past year, the non-occurrence of a traumatic event over a month before the intervention; angiography for the first time. Exclusion criteria: the history of asthma, bronchitis, chronic respiratory diseases, sensitivity to smell fragrant essential oils, drug addiction, mental disorders, angiography for acute myocardial infarction, hemodynamic disorder. Intervention: The intervention in two groups of aromatherapy with lavender and damask rose essential oil (with a concentration of 100% herbal medicines provided by companies Barij Essence Kashan) used separately, So that patients don't have Information from intervention. Essential to the hours of 22 to 6 am on angiography in patients and at a rate of two drops on a piece of gauze 2 × 2 has been attached to his collar. For intervention in the placebo group, from 22 hours to 6 am on angiography in patients and at a rate of three drops of water in a small glass container will be placed at a distance of 1 m from the patient. The main outcome variables: anxiety patients underwent coronary angiography.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017011325732N11
Registration date: 2017-02-15, 1395/11/27
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-02-15, 1395/11/27
Registrant information
Name
Alireza Emadi
Name of organization / entity
Semnan University of Medical Sciences, Semnan, Iran
Country
Iran (Islamic Republic of)
Phone
+98 23 3345 1336
Email address
are20935@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Semnan University of Medical Sciences, Deputy of Research and Technology.
Expected recruitment start date
2016-11-21, 1395/09/01
Expected recruitment end date
2017-03-21, 1396/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of lavender and Rosa Damascena scents on anxiety and vital signs of patients under coronary artery Angiography
Public title
Comparison of lavender and Rosa Damascena scents on anxiety and vital signs of patients under coronary artery Angiography
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: age 35-70 years, alert, a healthy sense of smell; no drugs, anti-anxiety and depression in the past year, the non-occurrence of a traumatic event over a month before the intervention; angiography for the first time. Exclusion criteria: the history of asthma, bronchitis, chronic respiratory diseases, sensitivity to smell fragrant essential oils, drug addiction, mental disorders, angiography for acute myocardial infarction, hemodynamic disorder.
Age
From 35 years old to 70 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 48
Randomization (investigator's opinion)
Randomized
Randomization description
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, Deputy of research and technology, Semnan University of Medical Sciences
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan
City
Semnan
Postal code
3514799442
Approval date
2016-11-21, 1395/09/01
Ethics committee reference number
IR.SEMUMS.REC.1395.200

Health conditions studied

1

Description of health condition studied
Anxiety
ICD-10 code
F41.9
ICD-10 code description
Anxiety disorder, unspecified

Primary outcomes

1

Description
Anxiety
Timepoint
Before intervention (before 22 hours) and immediately after the intervention (after 6 pm)
Method of measurement
Spielberger Anxiety Inventory

Secondary outcomes

1

Description
blood pressure
Timepoint
Before intervention (before 22 hours) and immediately after the intervention (after 6 pm)
Method of measurement
Scorpions pressure Riester (Germany)

2

Description
heart beat
Timepoint
Before intervention (before 22 hours) and immediately after the intervention (after 6 pm)
Method of measurement
Touch the right wrist radial pulse

3

Description
Respiratory rate
Timepoint
Before intervention (before 22 hours) and immediately after the intervention (after 6 pm)
Method of measurement
See the chest

Intervention groups

1

Description
The first intervention (aromatherapy with essential oils of lavender): Intervention for aromatherapy with lavender oil (with a concentration of 100% herbal medicines provided by companies Barij Essence Kashan) used. Essential to the hours of 22 to 6 am on angiography in patients and at a rate of two drops on a piece of gauze 2 × 2 has been attached to his collar.
Category
Prevention

2

Description
The second intervention (aromatherapy with essential oils of damask rose): intervention for aromatherapy with essential oils of damask rose (with a concentration of 100% herbal medicines provided by companies Barij Essence Kashan) used. Essential to the hours of 22 to 6 am on angiography in patients and at a rate of two drops on a piece of gauze 2 × 2 has been attached to his collar.
Category
Prevention

3

Description
Third intervention (placebo): From 22 to 6 am on angiography in patients and at a rate of three drops of water in a small glass container will be placed at a distance of 1 m from the patient.
Category
Behavior

4

Description
Fourth intervention (control): patients only receive routine care without any additional intervention.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Kosar Hospital
Full name of responsible person
Mohammad Reza Asgari
Street address
Kosar Hospital, BLVD Basij, Semnan
City
Semnan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Semnan University of Medical Sciences, Deputy of Research and Technology.
Full name of responsible person
Ali Rashidy-Pour
Street address
Semnan University of Medical Sciences, Deputy of Research and Technology, Basij Blvd, Semnan
City
Semnan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan University of Medical Sciences, Deputy of Research and Technology.
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Mohammadreza Asgari
Position
PhD in nursing
Other areas of specialty/work
Street address
Semnan University of Medical Sciences, Blvd Basij, Semnan
City
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Fax
+98 23 3344 8999
Email
are20935@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Mohammadreza Asgari
Position
PhD in nursing
Other areas of specialty/work
Street address
Semnan University of Medical Sciences, Blvd Basij, Semnan
City
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Fax
+98 23 3344 8999
Email
are20935@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Mohammadreza Asgari
Position
PhD in nursing
Other areas of specialty/work
Street address
Semnan University of Medical Sciences, Blvd Basij, Semnan
City
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Fax
+98 23 3344 8999
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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