Determining the effect of acupressure on anxiety in patients undergoing coronary angiography referred to Farshchian heart hospital in Hamadan in 1399.
Design
A randomized clinical trial with a control group, with three parallel groups
Settings and conduct
The present study will be conducted as a three-group clinical trial with the participation of 105 patients who are candidates for coronary angiography in the city of Hamadan. Participants will be randomly assigned to three groups. In group (A), intervention on GV20 points and in group (B), intervention on BL62 point will be applied for 10 minutes.The accuracy of the pressure applied by the researcher's finger to the desired point will be confirmed when the patient feels warm, heavy or numb at that point. No intervention will be performed in control group (C).Acupressure for all patients will be performed by a researcher.In this study, the one-blind method will be used. Anxiety levels will be measured by the Spielberger Situational Anxiety questionnaire, which is completed by the patient.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Having a desire to participate in the study, age 35 to 60 years,Stability of vital signs including blood pressure, pulse, respiration and temperature, having an anxiety score higher than 20 based on the questionnaire.
Exclusion criteria: Having any mental disorder being treated,Changes in the patient treatment process, decreased level of patient consciousness during the study
Intervention groups
Intervention in group (A) on GV20 points (in the middle of the anterior hairline or midline of the line connecting the apex of both ears) and in group (B), intervention on BL62 points (below the lower edge of the external ankle Foot) will be performed for 10 minutes, one hour before the angiography. No special action will be taken in the control group.
Main outcome variables
Anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160110025929N33
Registration date:2020-09-21, 1399/06/31
Registration timing:prospective
Last update:2020-09-21, 1399/06/31
Update count:0
Registration date
2020-09-21, 1399/06/31
Registrant information
Name
Mehdi Molavi Vardanjani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3422 5056
Email address
m.molavi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-22, 1399/07/01
Expected recruitment end date
2021-03-19, 1399/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of acupressure on anxiety of patients undergoing coronary angiography
Public title
The effect of acupressure on anxiety of patients undergoing coronary angiography
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Having a desire to participate in the study
Age 35 to 60 years
Stability of vital signs including blood pressure, pulse, respiration and temperature
Having an anxiety score higher than 20 based on the questionnaire
Exclusion criteria:
Make any changes in the patient treatment process
Having any mental disorder being treated
Decreased level of patient consciousness during the study
Age
From 35 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
105
Randomization (investigator's opinion)
Randomized
Randomization description
Simple random allocation will be done using a random number table. Patients will be randomly divided into three groups of intervention(A,B) and control (C).
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 Hamadan University of Medical Sciences
Street address
Shahid Fahmideh St., Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Approval date
2020-05-23, 1399/03/03
Ethics committee reference number
IR.UMSHA.REC.1399.222
Health conditions studied
1
Description of health condition studied
Coronary atherosclerosis
ICD-10 code
I25.1
ICD-10 code description
Atherosclerotic heart disease of native coronary artery
Primary outcomes
1
Description
Anxiety
Timepoint
Before and one hour after the intervention
Method of measurement
Spielberger Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group A: The intervention will be applied to the GV20 points (directly in the middle of the anterior hairline or the midline of the line connecting the apex of both ears) for 10 minutes, one hour before the angiography.
Category
N/A
2
Description
Intervention group B:The intervention will be applied to the BL62 point (below the lower edge of the outer ankle) for 10 minutes, one hour before the angiography.
Category
N/A
3
Description
Control group: No special action will be taken in the control group.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Farshchian hospital
Full name of responsible person
Babak Manafi
Street address
Shahid Fahmideh St., Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
B.manafi@umsha.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Saeed Bashirian
Street address
Shahid Fahmideh St., Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
s_bashirian@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Deputy of research and technology
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
Hamedan University of Medical Sciences
Full name of responsible person
Reza Borzou
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahid Fahmideh St., Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
borzou@umsha.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Reza Borzou
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahid Fahmideh St., Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
borzou@umsha.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Zahra Mirzaei
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shahid Fahmideh St., Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
Atena.mirzaie1851@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available