The goal of this study will to investigate the effect of aromatherapy on anxiety of patients experiencing coronary Angiography. A group of 120 patients hospitalized in Fateme -Zahra hospital in Sari will be randomly divided in two equal intervention and control groups. Demographic data sheets (6 questions), recording sheet of hemodynamic variables and Spiel Berger state- Trail anxiety inventory will distributed among two groups before and after aromatherapy. The characteristic of research sample are as following: coronary angiography for the first time and being completely vigilant. And exclusion criteria are: undergoing angiography catheterization of right ventricle; history of other invasive methods like echocardiography through oesophagus; history of heart valve disease and dangerous condition of disease. In intervention group, two drops of Lavendula and grape seed oil in control group will be administered foe the patients.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201107237067N1
Registration date:2011-10-29, 1390/08/07
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-10-29, 1390/08/07
Registrant information
Name
Homyra Tahmasebi
Name of organization / entity
Sari branch, Islamic Azad University, Sari, Iran
Country
Iran (Islamic Republic of)
Phone
+98 15 1213 3857
Email address
htahmasebi@iausari.ac.ir
Recruitment status
Recruitment complete
Funding source
Islamic Azad Univercity, Sari branch
Expected recruitment start date
2011-10-24, 1390/08/02
Expected recruitment end date
2011-12-24, 1390/10/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of aromatherapy on anxiety of patients experiencing coronary Angiography.
Public title
The effect of aromatherapy on anxiety of patients experiencing coronary Angiography.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: coronary angiography for the first time and being completely vigilant.
Exclusion criteria: undergoing angiography catheterization of right ventricle; history of other invasive methods like echocardiography through oesophagus; history of heart valve disease and dangerous condition of disease.
Age
From 30 years old to 90 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committe, Mazandaran University of medical sciences, Sari, Iran
Street address
Moalem squre
City
Sari
Postal code
19318-48161
Approval date
2011-09-07, 1390/06/16
Ethics committee reference number
4-90
Health conditions studied
1
Description of health condition studied
Anexity
ICD-10 code
F41.9
ICD-10 code description
Anxiety disorder, unspecified
Primary outcomes
1
Description
Anexity
Timepoint
8-12 hours before intervention and 5-10 minutes after of intervention
Method of measurement
Spilberger test
Secondary outcomes
1
Description
Hemodynamic parameter
Timepoint
8-12 hours before of intervention 5-10 minutes after of intervention
Method of measurement
Device
Intervention groups
1
Description
In intervention group, two drops of Lavendula will trickled on a small piece of cotton cloth with dimensions of 15×15 cm2 by an experienced nurse and patients will ask to hold this small piece of cotton cloth 3centimeters of their noses and inhale it, After half an hour their vital signs will controll and register by the nurse.
Category
Treatment - Drugs
2
Description
This procedure will done by grape seed oil (2 drop)in place of Lavendula in control group
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Fateme Zahra hospital
Full name of responsible person
Homyra tahmasebi
Street address
Artesh bolvor, Sari
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University, Sari branch, Sari, Iran
Full name of responsible person
Research assiatant-Homayoon motameni
Street address
Kilometer 7 khazar bolvar
City
Sari
Grant name
32-678
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University, Sari branch, Sari, Iran
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
Islamic Azad University, Sari branch, Sari, Iran
Full name of responsible person
Tahmasebi Homyra
Position
Lecturert -Faculty of Islamic Azad University, Sari branch, Sari, Iran
Other areas of specialty/work
Street address
Khilometer 7 khazar
City
Sari
Postal code
Phone
+98 15 1325 7439
Fax
Email
htahmasebi@iausari.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University, Sari branch, Sari, Iran
Full name of responsible person
Homeyra Tahmasbi
Position
lecturer-faculty of Islamic Azad University, Sari branch, Sari, Iran
Other areas of specialty/work
Street address
kilometer 7 khazar
City
Sari
Postal code
Phone
+98 15 1325 7439
Fax
Email
htahmasebi@iausari.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University, Sari branch, Sari, Iran
Full name of responsible person
Homeyra Tahmasbi
Position
Lecturer- Faculty of Islamic Azad University, Sari branch, Sari, Iran
Other areas of specialty/work
Street address
khazar 7kilometer
City
Sari
Postal code
Phone
+98 15 1325 7439
Fax
Email
htahmasebi@iausari.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)