Objective: The effect of aromatherapy and Quran voice on patients’ anxiety before angiography. Study design: Randomized clinical trial. Study population: patients admitted to the angiography unit at Shahid Beheshti Hospital. Major inclusion criteria: age over than 18; obtaining informed consent; no previous history of coronary angiography; No history of heart valve disease; non-impaired sense of smell; no hearing impaired; no history of other invasive methods like echocardiography through esophagus before angiography; no history of allergies. Major exclusion criteria: Patients trend to withdraw from the study; music and smells being unpleasant for patients. Sample Size: 90 patients. Intervention: Before coronary angiography in aromatherapy group the Rose aroma and in Quran voice group the voice of surah Yasin will be used. In control group only routine cares will be used. Before and 18 minutes after the intervention, the anxiety level will be measured using the spielberger questionnaire. Primary outcomes: changes in anxiety level.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013050111954N2
Registration date:2013-05-12, 1392/02/22
Registration timing:na
Last update:
Update count:0
Registration date
2013-05-12, 1392/02/22
Registrant information
Name
Mohammad Abbasinia
Name of organization / entity
Isfahan university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1792 2917
Email address
irajpour@nm.mui.ac.ir
Recruitment status
Not enough for processing
Funding source
Vice chancellor for research, Qom University of Medical Sciences
Expected recruitment start date
2014-05-22, 1393/03/01
Expected recruitment end date
2013-08-23, 1392/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of aromatherapy and Quran voice on patients’ anxiety before angiography.
Public title
The effect of aromatherapy and Quran voice on patients’ anxiety before angiography.
Purpose
Supportive
Inclusion/Exclusion criteria
Major inclusion criteria: age over than 18; obtaining informed consent; no previous history of coronary angiography; No history of heart valve disease; non-impaired sense of smell; no hearing impaired; no history of other invasive methods like echocardiography through esophagus before angiography; no history of allergies. Major exclusion criteria: Patients trend to withdraw from the study; music and smells being unpleasant for patients.
Age
From 19 years old to 100 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
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 Qom University of Medical Science
Street address
Qom University of Medical Science, Saheli Street, Qom. Postal cod: 3713649373
City
Qom
Postal code
3713649373
Approval date
2013-08-23, 1392/06/01
Ethics committee reference number
8758/15/ج
Health conditions studied
1
Description of health condition studied
Ischaemic heart diseases
ICD-10 code
I20, I21,
ICD-10 code description
Ischaemic heart diseases
Primary outcomes
1
Description
Anxiety
Timepoint
Before and 18 minutes after the intervention
Method of measurement
spielberger questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
In the aromatherapy group before coronary angiography the Rose aroma will be used.
Category
Prevention
2
Description
In the Quran voice group before coronary angiography the voice of surah Yasin will be used.
Category
Prevention
3
Description
In the control group only routine cares such as meeting with family and patient education will be used.