The effect of auriculotherapy on physiological and psychological criteria in patients before coronary angiography
Design
The single-blind clinical trial and by coin-throwing patients were divided into groups, intervention and control.
Settings and conduct
This study was performed in the selected hospital of AJA University of Medical Sciences (502 Tehran Hospital).Angiography Unit, in 1398.
This is a single-blind study.
The method of auriculotherapy was described for both control and intervention groups, and only patients did not know that they were in control or intervention groups.
Participants/Inclusion and exclusion criteria
1. Age less than 70 years.
2. Literacy in reading and writing.
3. Perform angiography for the first time.
4. Angiography is not the type of emergency.
Intervention groups
Auriculotherapy is a technique in which a person feels relaxed by touching a specific point in the ear, Ericulotherapy was performed on the intervention group and touch of false ear in the control group.
The effect of auriculotherapy on physiological and psychological criteria in patients before coronary angiography.
Public title
Effect of auriculotherapy on physiological and psychological Parameters, in patients undergoing coronary angiography in selected hospitals of AJA University of Medical Sciences
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Reading and writing skills
Age less than 70 years
Perform angiography for the first time
No ear ulcer
Do not have a history of hospitalization in the heart department.
Angiography is not an emergency.
They have not previously undergone other invasive procedures such as Transesophageal echocardiography
Do not have a history of known heart valve diseases
Do not have physical disabilities.
No serious psychiatric disorder
Do not be part of the medical staff
Their first-degree relatives have not previously had coronary angiography
Exclusion criteria:
Drug Addiction
History of performing auriculotherapy
Do not have a history of anxiety and depression based on findings in the file.
Serious psychiatric disorder based on findings in the file.
Do not be part of the medical staff.
Age
From 18 years old to 70 years old
Gender
Male
Phase
N/A
Groups that have been masked
Care provider
Sample size
Target sample size:
94
Actual sample size reached:
94
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were selected by convenience sampling and were randomly divided By throwing coins into two groups of intervention and control.
Blinding (investigator's opinion)
Single blinded
Blinding description
For patients, the method of auriculotherapywas explained, but none of the samples knew that they were in the intervention or control group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
AJA University of Medical Sciences
Street address
Army University of Medical Sciences, Shahid Etemadzadeh Street, West Fatemi Ave, Tehran
City
Tehran
Province
Tehran
Postal code
1613/635751
Approval date
2019-04-28, 1398/02/08
Ethics committee reference number
IR.AJAUMS.REC.1398.025
Health conditions studied
1
Description of health condition studied
Anxiety
ICD-10 code
ICD-10 code description
2
Description of health condition studied
Stress
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Anxiety
Timepoint
Before the intervention, DASS21 will be filled in by patients and 60 minutes before angiography will be performed at predetermined angiography, for 4 minutes and 1 minute at each point. ,. Ten minutes after the auriculotherapy intervention, the DASS21 scale was again filled by the patients.
Method of measurement
Anxiety and Stress Measurement Questionnaire DASS-21
Secondary outcomes
1
Description
Anxiety
Timepoint
Anxiety variable was assessed by DASS_21 questionnaire one hour before and ten minutes after intervention.
Method of measurement
Questionnaire DASS_21
2
Description
Stress
Timepoint
One hour before and ten minutes after intervention the stress variable was assessed by DASS_21 questionnaire.
Method of measurement
Questionnaire DASS_21
3
Description
Systolic blood pressure
Timepoint
One hour before and ten minutes after intervention diastolic blood pressure was measured by sphygmometer model BC 80.
Method of measurement
Sphygmometer model BC 80 Made in Germany
4
Description
Diastolic blood pressure
Timepoint
One hour before and ten minutes after the intervention, diastolic blood pressure was measured by a sphygmometer.
Method of measurement
sphygmometer model BC 80 Made in Germany
5
Description
Respiratory rate
Timepoint
One hour before and ten minutes after the intervention, the variable respiratory rate was counted by the researcher in one minute.
Method of measurement
The respiratory rate was counted by the researcher in one minute
6
Description
pulse rate
Timepoint
One hour before and ten minutes after the intervention, the variable pulse rate was counted by the researcher in one minute.
Method of measurement
The number of radial pulses was counted by the researcher in one minute
Intervention groups
1
Description
Intervention group: Acupressure (auriculotherapy) was performed by the researcher 60 minutes before angiography at predetermined points. Using the thumb, gentle counter-pressure was applied to the counterclockwise for 4 minutes at each point for 1 minute.
Category
Prevention
2
Description
Control group: Acupressure (auriculotherapy) was performed by the researcher 60 minutes before angiography at predetermined points. But the auriculotherapy was performed in the false points in the ear.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran 502 Hospital
Full name of responsible person
Vahid rahimi
Street address
North Spring Street corner, Taleghani street, Tehran
City
Tehran
Province
Tehran
Postal code
6717855379
Phone
+98 21 8882 2222
Fax
+98 21 8882 8001
Email
zahrafarsi@gmail.com
Web page address
https://www.ajaums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Dr Zahra Farsi
Street address
Army University of Medical Sciences, Shahid Etemadzadeh Street, West Fatemi Ave, Tehran
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 8609 6350
Email
arasajadi@yahoo.com
Web page address
http://www.ajaums.ac.ir/page/contact-us/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Artesh 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
Artesh University of Medical Sciences
Full name of responsible person
Dr Zahra Farsi
Position
Research Assistant
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Army Nursing School, Next to Army Khanevadeh Hospital, opposite Khor St., Shariati Ave., Shiraz Ave., Tehran