Impact of inhalation aromatherapy with damask rose on stress, anxiety and hemodynamic parameters of patients undergoing coronary angiography One-blind randomized clinical trial in two groups (intervention and placebo)
Purpose: To determine the effect of inhaled aromatherapy on stress, anxiety and hemodynamic parameters of patients undergoing coronary artery angiography. Design: A single-blind randomized clinical trial. How to do Candidate patients for coronary angiography in the angiographic section will be included in the following criteria: (a) first time angiography; (b) lack of critical clinical conditions; (c) non-compliance with angioplasty; (d) lack of alcohol and narcotic addiction; (E) Full person alertness and ability to answer the questioner's questions; (i) Absence of diagnosed anxiety disorder based on the physician's opinion. Patients with the following criteria will be excluded from the study: (a) aromatherapy intolerance for any cause; (b) any disorder or instability in the state of consciousness or hemodynamic Leads to the impossibility of continuing the study; (c) the reluctance to continue to participate in Study.Interventions: In the intervention group, an aroma of five drops of 40% Rose Essence is made by attaching absorbent Cloth to the patient's collar for 20 minutes. In the placebo group, five drops of water are placed on the absorbent Cloth attached to the patient's collar for 20 minutes. Main outcome measurement: Stress, anxiety and hemodynamic variables with the following questionnaires will be considered. (A) Stress is measured by the stress section of the dass21 questionnaire; (b) Anxiety is measured by the anxiety section of the dass21 questionnaire; (c) After measuring the hemodynamic variables (systolic blood pressure, diastolic blood pressure, mean arterial blood pressure, heart rate and respiration) with a monitoring device and a clock, it is recorded on the check list.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201702019759N8
Registration date:2017-07-31, 1396/05/09
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-07-31, 1396/05/09
Registrant information
Name
Ali Bikmoradi
Name of organization / entity
Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0439
Email address
bikmoradi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-Chancellor of Research and Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2017-08-22, 1396/05/31
Expected recruitment end date
2018-03-20, 1396/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Impact of inhalation aromatherapy with damask rose on stress, anxiety and hemodynamic parameters of patients undergoing coronary angiography One-blind randomized clinical trial in two groups (intervention and placebo)
Public title
The impact of the aromatherapy with damask rose on stress, anxiety and hemodynamic parameters of patients undergoing angiography
Purpose
Supportive
Inclusion/Exclusion criteria
Candidate patients for coronary angiography in the angiographic section will be included in the following criteria: (a) first time angiography; (b) lack of critical clinical conditions; (c) non-compliance with angioplasty; (d) lack of alcohol and narcotic addiction; (E) Full person alertness and ability to answer the questioner's questions; (i) Absence of diagnosed anxiety disorder based on the physician's opinion. Patients with the following criteria will be excluded from the study: (a) aromatherapy intolerance for any cause; (b) any disorder or instability in the state of consciousness or hemodynamic Leads to the impossibility of continuing the study; (c) the reluctance to continue to participate in Study
Age
From 18 years old to 64 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
98
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Single
Other design features
In this study, we will use balanced block randomization and patients will be alocated in intervention group (aromatherapy) and control (inhalation of distilled water). Blinding will done for research analysing committe.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Comittee of Hamadan University of Medical Sciences
Street address
Fahmideh St., Hamadan University of Medical Sciences
City
Hamadan
Postal code
6517838698
Approval date
2017-06-17, 1396/03/27
Ethics committee reference number
IR.UMSHA.REC.1396.249
Health conditions studied
1
Description of health condition studied
Stress
ICD-10 code
F43.0
ICD-10 code description
Acute stress reaction
2
Description of health condition studied
Atherosclerotic heart disease
ICD-10 code
I25.1
ICD-10 code description
I25.1
3
Description of health condition studied
Anexity
ICD-10 code
F41.1
ICD-10 code description
Generalized anxiety disorder
4
Description of health condition studied
Coronary angiography
ICD-10 code
(Y70-Y82)
ICD-10 code description
Medical devices associated with adverse incidents in diagnostic and therapeutic use
Primary outcomes
1
Description
Hemodynamic parameter
Timepoint
Before and after the intervention
Method of measurement
Using a heart monitor and a clock
2
Description
Stress
Timepoint
Before and after the intervention
Method of measurement
Using the stress section of the dass questionnaire 21
3
Description
Anxiety
Timepoint
Before and after the intervention
Method of measurement
Using the anxiety section of DASS 21 questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
In the intervention group, patients inhale five drops of 40% Rosa Damascus Essence on absorbent Cloth attached to their collar for 20 minutes.
Category
Treatment - Drugs
2
Description
In the placebo group, patients inhale five drops of distilled water are placed on an absorbent cloth attached to their collar for 20 minutes.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Beasat Therapeutic and Educational Center of Hamadan
Full name of responsible person
Azad Fatahi
Street address
Nursing and Midwifery School, Hamadan University of Medical Sciences, Shaheed Fahmideh Ave
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor of research and technology
Full name of responsible person
Dr. Saeed Bashirian
Street address
Fahmideh ave., Deputy of research and technology, Hamadan University of Medical |Sciences
City
Hamadan
Grant name
از محل یک درصد بودجه طرح های تحقیقاتی دانشگاه
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor 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
School of public health, Hamadan University of Medical Sciences
Full name of responsible person
Dr. Ali Bikmoradi
Position
Associate professor
Other areas of specialty/work
Street address
Fahmideh Ave., Department of health economics and management, School of public health, Hamadan University of Medical Sciences
City
Hamadan
Postal code
6517838698
Phone
+98 81 1838 0439
Fax
+98 81 1838 0447
Email
bikmoradi@umsha.ac.ir
Web page address
www.umsha.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of public health, Hamadan University of Medical Sciences
Full name of responsible person
Dr. Ali bikmoradi
Position
PhD of Medical management/Associate professor
Other areas of specialty/work
Street address
Fahmideh Ave., Department of health economics and management, School of public health, Hamadan University of Medical Sciences
City
Hamadan
Postal code
6517838698
Phone
+98 81 3838 0439
Fax
+98 81 3838 0447
Email
bikmoradi@umsha.ac.ir
Web page address
http://umsha.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
School of public health, Hamadan University of Medical Sciences
Full name of responsible person
Dr. Ali bikmoradi
Position
PhD of Medical management/Associate professor
Other areas of specialty/work
Street address
Fahmideh Ave., Department of health economics and management, School of public health, Hamadan University of Medical Sciences
City
Hamadan
Postal code
6517838698
Phone
+98 81 3838 0439
Fax
+98 81 3838 0447
Email
bikmoradi@umsha.ac.ir
Web page address
http://www.umsha.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)