effect of auricular acupressure on patient’s comfort after coronary artery interventions
Design
A clinical trial with a control group, randomized from among the available samples, on 84 patients, is used for randomization by envelope punching method.
Settings and conduct
Patients undergoing coronary artery interventions at Farshchian Heart Center, Hamadan, are randomly assigned to intervention and control groups. For the patients who are included in the intervention group, TF2, SF5, AT2 and HX1 points in the ear are identified and pressure plant labels are applied to these points and remain for 2 hours
Participants/Inclusion and exclusion criteria
Inclusion criteria : patients who are candidates for non-emergency radial coronary artery interventions, the ability to recognize the NRS scale, no mental disorders, the consent of the attending physician to participate in the research;
Exclusion criteria: feeling comfortable in the patient, the presence of damage or malignancy in the ear area
Intervention groups
Patients who are included in the intervention group, ear acupressure with pressure plant labels is performed at TF2, SF5, AT2 and HX1 points
Main outcome variables
Comfort, pain and physiological indicators
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231028059875N1
Registration date:2024-01-30, 1402/11/10
Registration timing:prospective
Last update:2024-01-30, 1402/11/10
Update count:0
Registration date
2024-01-30, 1402/11/10
Registrant information
Name
Fatemeh Asadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 918 083 1069
Email address
asadifatemeh1379@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-03-20, 1403/01/01
Expected recruitment end date
2024-06-21, 1403/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
effect of auricular acupressure on patient’s comfort after coronary artery interventions
Public title
The effect of auricular acupressure on patient’s comfort
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Candidate patients for non-emergency radial coronary artery interventions
Ability to recognize NRS scale
Consent of the attending physician to participate in the research
Not having mental disorders with doctor's approval
Exclusion criteria:
Feeling comfortable and not having pain in the radial area
Presence of damage and malignancy in the ear
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
84
Randomization (investigator's opinion)
Randomized
Randomization description
We will use the method of punching envelopes to randomize the samples; In this way, there are two separate envelopes, in envelope number one, there are 42 papers related to the acupressure intervention group with the letter A, and in envelope number 2, there are 42 papers in which the letter B means the control group. We put the envelopes it in front of the patient. And we ask him to take a number of papers from inside one of the envelopes randomly without switching. Depending on which one he chooses, the patient will be placed in the same group.
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 science
Street address
Hamadan university of medical science, Shahid Fahmideh Blvd, Hamadan, Iran
City
Hamadan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۷۳۶
Approval date
2024-01-21, 1402/11/01
Ethics committee reference number
IR.UMSHA.REC.1402.640
Health conditions studied
1
Description of health condition studied
Coronary artery interventions (angiography and angioplasty)
ICD-10 code
Z98.61
ICD-10 code description
Coronary angioplasty status
Primary outcomes
1
Description
Comfort
Timepoint
Before the intervention, 30 and 120 minutes after the intervention
Method of measurement
Numerical rating scale
2
Description
Pain
Timepoint
Before the intervention, 30 and 120 minutes after the intervention
Method of measurement
Numerical rating scale
3
Description
Heart rate
Timepoint
Before the intervention, 30 and 120 minutes after the intervention
Method of measurement
Number of beats per minute, pulse oximetry device
4
Description
Mean arterial pressure
Timepoint
Before the intervention, 30 and 120 minutes after the intervention
Method of measurement
Sphygmomanometer
5
Description
Oxygen saturation percentage of arterial blood
Timepoint
Before the intervention, 30 and 120 minutes after the intervention
Method of measurement
pulse oximetry device
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the intervention group, the benefits of acupressure and sticky plant seeds are explained, and patients are asked to ask any questions they may have. It will be explained to them that pressure plant labels will be placed on TF2, SF5, AT2 and HX1 points of their right ear for 2 hours. Then, the comfort of the patient, the severity of the patient's pain, the average arterial pressure, the heart rate and the oxygen saturation of the arterial blood will be measured three times at zero minute, 60 minutes later and 120 minutes after zero with the help of the available tools. It should be noted that minute zero is the moment the patient enters the ward
Category
Treatment - Devices
2
Description
Control group: In relation to the control group, it should be noted that no specific intervention is performed and after that the research criteria include patient comfort, patient pain intensity, mean arterial pressure, heart rate and arterial blood oxygen saturation in three times at zero minutes. It will be checked 60 minutes later and 120 minutes after the zero minute. It is important to mention that both groups will not be deprived of the routine medical procedures that are performed in the department after coronary interventions
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
مرکز قلب فرشچیان
Full name of responsible person
فاطمه اسدی
Street address
Farshchian heart center, Fahmideh St
City
Hamadan
Province
Hamadan
Postal code
6517839131
Phone
+98 21 3838 1740
Fax
Email
hcvc@umsha.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Reza Shokoohi
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh St, Hamadan
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
shokoohi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Fatemeh Asadi
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh St
City
Hamadan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3838 0447
Email
asadifatemeh1379@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Hiva Azami
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh St
City
Hamadan
Province
Hamadan
Postal code
6517838698
Phone
+98 81 3838 0447
Email
hiva64@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Fatemeh Asadi
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh St
City
Hamadan
Province
Hamadan
Postal code
6517838698
Phone
+98 81 3838 0447
Email
asadifatemeh1379@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
After completing the research project and consulting with the professors, I will make a decision about this
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