The aim of this study was to evaluate the impact of a designed intervention protocol on myocardial infarction's outcome in Miyandoab Abbassi hospital. The frequency of chest pain; readmission and anxiety were examined as three important outcomes. The study included 120 patients with myocardial infarction who were divided into two groups (each n = 60). At first, samples of the control group were chosen and after that, the intervention group were selected. Inclusion criteria : Age between 30-70 years; diagnosis of heart attack for the first time by a cardiologist; not known psychiatric disorders and psychiatric treatment based on previous records; absence of any cognitive, speech or hearing impairment; absence of pain during training; access to telephone; absence of untreated heart failure, uncontrolled arrhythmias or severe and persistent chest pain. Exclusion criteria: The emergence of critical situations for patients during the study; unwillingness to continue the study. The control group received the usual care and intervention group received designed nursing protocol. This protocol includes training and rehabilitation. For education, training manual, face to face training, and educational videos were used. The rehabilitation activities emphasis on activities and aerobic exercise. Eventually, data was collected using Spiel Berger anxiety inventory and demographic check list at the beginning of admition and three months after discharge.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016062625366N17
Registration date:2016-08-18, 1395/05/28
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-08-18, 1395/05/28
Registrant information
Name
Rahim Baghaei
Name of organization / entity
Urmia University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 44 3275 4916
Email address
rbaghaei@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research Urmia University of Medical Sciences
Expected recruitment start date
2015-11-21, 1394/08/30
Expected recruitment end date
2016-05-17, 1395/02/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of designed nursing protocol and common treatment on the frequency of chest pain, readmission and anxiety in myocardial infarction patients
Public title
Impact of education and rehabilitation on anxiety and readmission of myocardial infarction patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria : Age between 30-70 years; diagnosis of heart attack for the first time by a cardiologist; not known psychiatric disorders and psychiatric treatment based on previous records; absence of any cognitive, speech or hearing impairment; absence of pain during training; access to telephone; absence of untreated heart failure, uncontrolled arrythmias or severe and persistent chest pain. Exclusion criteria: The emergence of critical situations for patients during the study; unwillingness to continue the study.
Age
From 30 years old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
-
Secondary trial Id
-
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Urmia University of Medical Sciences
Street address
Ethics Committee of Urmia University of Medical Sciences, Resalat St., Urmia, Iran
City
Urmia
Postal code
5714783734
Approval date
2015-11-21, 1394/08/30
Ethics committee reference number
IR.UMSU.IRC.1394
Health conditions studied
1
Description of health condition studied
myocardial infarction
ICD-10 code
121
ICD-10 code description
Acute myocardial infarction
Primary outcomes
1
Description
chest pain
Timepoint
three months after intervention
Method of measurement
check list
2
Description
Readmission
Timepoint
three months after intervention
Method of measurement
check list
3
Description
Anxiety
Timepoint
At the time of admission and three months after discharge
Method of measurement
Spielberger anxiety inventory
Secondary outcomes
empty
Intervention groups
1
Description
In this study, the control group received usual care.
Category
Rehabilitation
2
Description
Intervention group: for the intervention group designed nursing protocol was implemented. Designed nursing protocol consisted of two parts. In training part, after stabilization the patient's condition, training was conducted in two sessions of 2 hours through face to face education and training manual. The training included information about risk factors of heart disease and myocardial infarction; clinical manifestations, treatment and complications of myocardial infarction; warning signs of recurrent heart attack; intensity of the activities after myocardial infarction and lifestyle changes including weight loss, smoking cessation and diet modification. The second part of designed nursing protocol was cardiac rehabilitation; started since the beginning of patients’ admission in cardiac care unit. Rehabilitation starts from the time of admission up to three months after discharg. Rehabilitation program focused on aerobic exercise consisted of three sessions per week for 8 weeks. Each session took 50 minutes consisting of 10 minutes for warm up, 30 minutes for isometric exercises or walking and 10 minutes for cooling down.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Miyandoab Abbassi Hospital
Full name of responsible person
Abolhassan Sharifi
Street address
Abbassi hospital,Shohadayeh Karaveran street, Miyandoab, West Azarbijan, Iran
City
Miyandoab
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Urmia University of Medical Sciences
Full name of responsible person
Vice chancellor for research
Street address
Vice chancellor for research, Urmia University of Medical Sciences, Resalat St., Urmia, Iran
City
Urmia
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research of Urmia University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Urmia University of Medical Sciences
Full name of responsible person
Aboulhassan Sharifi
Position
MS student
Other areas of specialty/work
Street address
Abbassi hospital,Shohadayeh Karaveran street, Miyandoab, West Azarbijan, Iran
City
Miyandoab
Postal code
5971934649
Phone
+98 44 4535 1800
Fax
+98 45350924
Email
yarjan79@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Nursing and Midwifery University
Full name of responsible person
Rahim Baghaei
Position
Associat profesor
Other areas of specialty/work
Street address
Nursing & midwifery school, Urmia University of Medical Sciences Campus, 11th Km of Sero Road, Urmia, Iran
City
Urmia
Postal code
5714783734
Phone
+98 44 3275 4918
Fax
+98 44 3275 4913
Email
rbaghari2001@yahoo. com
Web page address
umsu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Urmia University of Medical Sciences
Full name of responsible person
Aboulhassan Sharifi
Position
MS Student
Other areas of specialty/work
Street address
Abbassi hospital,Shohadayeh Karaveran street, Miyandoab, West Azarbijan, Iran
City
Miyandoab
Postal code
0098445971934649
Phone
+98 44 4535 1800
Fax
+98 44 4535 0924
Email
yarjan79@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)