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Investigating the Effect of Early Mobilization Program on Physiological Indicators and Cardiac Anxiety of Patients with Acute Myocardial Infarction

Protocol summary

Study aim
Determining the effect of patient's early mobility program on physiological parameters and heart-focused anxiety in patients with acute myocardial infarction
Design
Clinical trial with control group, with parallel groups, one-way blind,Randomized
Settings and conduct
Patients with acute myocardial infarction , hospitalized in the cardiac intensive care unit of 9 Dey and Shahid Ashrafi Khomeini Shahr hospitals, after obtaining written consent, are randomly divided into two groups of intervention and control. The statistical analyzer has only information about raw data
Participants/Inclusion and exclusion criteria
Inclusion criteria:Personal preference, age less than 75, hemodynamic stability, uncomplicated myocardial infarction, no history of previous myocardial infarction, no history of overdose use of beta-blockers, no contraindications to exercise and movement, no acute psychiatric disorders, Absence of complete heart block, atrial-ventricular block two and three, life-threatening dysrhythmia, inferior myocardial infarction, life-threatening cardiac complications and thrombophlebitis, no history of open heart surgery, discharge fraction more than 40,% Non-entry conditions: Inability of the patient to continue to participate in the study, inability to apply or follow the study protocol.
Intervention groups
Intervention group: Patients with acute myocardial infarction , during an early mobility program, after 6 hours of complete rest, step out of bed in 6 steps and monitor his vital signs. Before and after the intervention, the patient's cardiac anxiety questionnaire is completed. control group: Patients with acute myocardial infarction are admitted to the cardiac intensive care unit, who are discharged according to the ward routine
Main outcome variables
Blood pressure number, heart rate, arterial blood oxygen saturation, The cardiac anxiety questionnaire score

General information

Reason for update
Acronym
EM and MI Study
IRCT registration information
IRCT registration number: IRCT20220116053740N1
Registration date: 2022-05-01, 1401/02/11
Registration timing: registered_while_recruiting

Last update: 2022-05-01, 1401/02/11
Update count: 0
Registration date
2022-05-01, 1401/02/11
Registrant information
Name
Reihane Askari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3359 7811
Email address
reyhaneaskari90@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-09, 1401/01/20
Expected recruitment end date
2022-06-20, 1401/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the Effect of Early Mobilization Program on Physiological Indicators and Cardiac Anxiety of Patients with Acute Myocardial Infarction
Public title
Evaluation of the Effect of Early mobilization in Myocardial Infarction
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Personal Desire and Satisfaction of Patients to Participate in Research The Patient must be less than 75 Years old The Patient has Hemodynamic stability The Units to be studied are Uncomplicated Myocardial Infarction The Patient has no Previous history of Myocardial Infarction The Patient has no History of Overdosing on Beta-blockers No Sports Contraindications and Movement restrictions Absence of Acute psychiatric disorders Absence of Complete Heart Block, Atrioventricular Node two and three Block, Life-threatening Dysrhythmia, Inferior Myocardial Infarction, Life-Threatening Cardiac Complications and Thrombophlebitis Has not had any Open Heart Surgery Left Ventricular Ejection Fraction is more than 40%
Exclusion criteria:
The patient's unwillingness to continue participating in the study Inability to apply or follow the study protocol in terms of recurrence of previous physical and mental illness Physician diagnoses during the intervention that the subject units can not continue to participate in the study Occurrence of any threatening condition during the intervention in the patient that requires emergency nursing or medical intervention
Age
To 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Data analyser
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
After selecting the samples based on the inclusion criteria, the samples are placed in two groups of intervention and control using a table of random numbers. Thus, the researcher first determines that all patients to whom the even number is assigned are in the intervention group and patients to whom the odd number is assigned are in the control group. Then close the eyes and put your finger on one of the digits in the random table and write down the house number and the starting point number column. The direction of movement is set horizontally to the right, up and then to the left.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants and statistical analyzers are blinded by protocol coding and questionnaires
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Street address
Vice Chancellor for Research and Technology, Hezar Jerib St. Isfahan University of Medical Sciences and Health Services, Building No. 4,
City
Isfahan
Province
Isfehan
Postal code
8193933388
Approval date
2021-10-30, 1400/08/08
Ethics committee reference number
IR.MUI.NUREMA.REC.1400.150

Health conditions studied

1

Description of health condition studied
Acute myocardial infarction
ICD-10 code
I23.8
ICD-10 code description
Other current complications following acute myocardial infarction

Primary outcomes

1

Description
Physiological indicators
Timepoint
Before intervention, 24 hours after intervention, 72 hours after intervention
Method of measurement
Hemodynamic monitoring system, Checklist

Secondary outcomes

1

Description
Anxiety focused on the heart
Timepoint
Before and after the intervention
Method of measurement
The Cardiac Anxiety Questionnaire

Intervention groups

1

Description
Intervention group: Patients with acute myocardial infarction who begin to move as planned after 6 hours of complete rest.
Category
Other

2

Description
Control group: Patients with acute myocardial infarction, who begin to move according to the ward routine.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
9 Dey Manzariye Hospital
Full name of responsible person
Reihane Askari
Street address
Shiva St., namaz
City
KHomeini shahr
Province
Isfehan
Postal code
4311184191
Phone
+98 31 3370 5890
Email
reyhaneaskari90@yahoo.com

2

Recruitment center
Name of recruitment center
SHahid Ashrafi Hospital
Full name of responsible person
Reihane Askari
Street address
Bouali St.
City
KHomeini shahr
Province
Isfehan
Postal code
1135184148
Phone
+98 31 3362 5081
Email
reyhaneaskari90@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Shaghayegh Haghjoi Javanmard
Street address
Vice Chancellor for Research and Technology, Hezar Jerib St.Isfahan University of Medical Sciences and Health Services Building, No. 4,
City
Isfahan
Province
Isfehan
Postal code
8193119385
Phone
+98 31 3668 7898
Email
sh_haghjoo@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Reihane Askari
Position
Nursing Graduate Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Isfahan University of Medical Sciences, Hezar Jerib St., Azadi Square, Isfahan,
City
Isfahan
Province
Isfehan
Postal code
8174673548
Phone
+98 31 3360 9397
Email
reyhaneaskari90@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ahmadreza Yazdan nik
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Isfahan University of Medical Sciences, Azadi Square,Hezar Jerib St., Isfahan University of Medical Sciences,
City
Isfahan
Province
Isfehan
Postal code
8174673548
Phone
+98 31 3792 7500
Email
Yazdannik@nm.mui.ac.ir
Web page address
http://nm.mui.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Reihane Askari
Position
Nursing Graduate Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Isfahan University of Medical Sciences, Hezar Jerib St., Azadi Square
City
Isfahan
Province
Isfehan
Postal code
8174673548
Phone
+98 31 3360 9397
Email
reyhaneaskari90@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is 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
No - There is not a plan to make this available
Clinical Study Report
Yes - There is 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
Not applicable
Title and more details about the data/document
Information about the original message and the study protocol and clinical report will be shared as an article
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
All people in the field of medicine and nursing
Under which criteria data/document could be used
People working on acute myocardial infarction
From where data/document is obtainable
Email to the person performing the project
What processes are involved for a request to access data/document
Email to the applicant, request from the Vice Chancellor for Research, if they agree, provide information to the applicant
Comments
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