Efficiency of applying P6 acupressure on nausea , vomiting and comfort in myocardial infarction patients in cardiovascular Farshchian hospital in Hamadan in 2020
The aim of study is determine the effect of applying P6 acupressure on nausea , vomiting and comfort in myocardial infarction patients in cardiovascular Farshchian hospital in Hamadan in 2020
Design
The present study in Farshchian Hospital of Hamadan will be performed on 81 patients with cardiac infarction in three groups (intervention, placebo and control). Sampling will be done by simple randomization. Visual analog scales will be used to assess the severity of nausea.
Settings and conduct
In the intervention group(A), the bracelet will be closed for 6 hours with the aim of applying pressure to the p6 point. Vomiting will be checked within 24 hours after the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age between 35 and 70 years, Having nausea and vomiting, Absence of physical and skin disorders, Full awareness
Intervention groups
In the intervention group, the bracelet will be closed for 6 hours for pressing the p6 point.
Group (B) Placebo: In this group, the researcher determines the point p6, which is located on the inside of the forearm and in the cavity between the bones of the forearms, three fingers wide above the wrist fold, and in the left hand (single-handed) Close the bracelet without the push of a button for 6 hours.
Control group (C): No bracelets are used for them in this group.
Main outcome variables
Nausea and vomiting
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160110025929N30
Registration date:2020-07-06, 1399/04/16
Registration timing:registered_while_recruiting
Last update:2020-07-06, 1399/04/16
Update count:0
Registration date
2020-07-06, 1399/04/16
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
2020-05-21, 1399/03/01
Expected recruitment end date
2021-05-22, 1400/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficiency of applying P6 acupressure on nausea , vomiting and comfort in myocardial infarction patients in cardiovascular Farshchian hospital in Hamadan in 2020
Public title
Efficiency of applying P6 acupressure on nausea , vomiting and comfort
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Full awareness
Having nausea and vomiting
Age between 35 and 70 years
Exclusion criteria:
Unwilling to participation in the study
Physical and skin disorders
Decreased consciousness, acute delirium
Age
From 35 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
81
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method used for this study is blocked randomization. Blocks containing 6 patients are made for allocating patients to 3 treatment options of A, B and C. Blocks in 3 types of sequences (AABBCC, ABCABC, CABCAB) and 3 of each (total of 9 blocks) are used. To randomly assigning blocks, a simple random sequence is used. No other method of stratified randomization is utilized.
Blinding (investigator's opinion)
Single blinded
Blinding description
In the present study, placebo in group B will be used so these participants will be blind.
Placebo
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
2020-01-24, 1398/11/04
Ethics committee reference number
IR.UMSHA.REC.1398.959
Health conditions studied
1
Description of health condition studied
Myocardial infarction
ICD-10 code
I21.0
ICD-10 code description
ST elevation (STEMI) myocardial infarction of anterior wall
Primary outcomes
1
Description
Nausea and vomiting
Timepoint
Before and after intervention
Method of measurement
Visual Analog Sclae
Secondary outcomes
1
Description
pain
Timepoint
Before and after intervention
Method of measurement
Visual Analog Scale
Intervention groups
1
Description
Intervention group A: In this group, the p6 point researcher, who is on the inside of the left forearm, will fasten the bracelet with the push of a button for 6 hours with the aim of applying pressure to the p6 point.
Category
N/A
2
Description
Control group(C): No bracelets are used for them in this group.
Category
N/A
3
Description
In placebo group( B), the researcher determines the p6 point on the inside of the forearm. Then in the left hand, he will use the simple bracelet for 6 hours without putting pressure on p6 point.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Farshchian hospital
Full name of responsible person
Mahnaz Khatiban
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
m.khatiban@umsha.ac.it
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_bashirina@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
Mahnaz Khatiban
Position
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
m.khatiban@umsha.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Mahnaz Khatiban
Position
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
m.khatiban@umsha.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Mehdi Molavi
Position
Instructor
Latest degree
Master
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
m.molavi@umsha.ac.ir
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