Determining the mean score of post traumatic stress in patients in the intervention group.
Determining the mean score of post traumatic stress in patients in the control group.
Comparison of mean score of post traumatic stress disorder in the control and intervention group.
Design
This is a clinical trial with control group in which 80 patients with acute myocardial infarction, who have inclusion criteria, will be selected, and they are divided into two groups by block method.
Settings and conduct
This study will be conducted in the coronary care unit of Amir Kabir Hospital in Arak. Spiritual care is provided by the nurses who have received adequate training in this regard.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
The patient has an acute myocardial infarction; according to a cardiologist's diagnosis; Being alert; Speaking in Persian; Being Muslim; Have no known mental illness; Have no mental retardation.
Exit criteria:
Unwillingness to continue the study; Occurrence of a new heart attack; Occurrence of any severe complications of myocardial infarction (cardiogenic shock and severe heart failure); The necessity of using a pacemaker and implantable cardioverter defibrillator; ;Performing a coronary artery bypass graft surgery;
Patient death; Displacement of the patient's place of residence.
Intervention groups
For patients in the intervention group, the spiritual care program includes three sessions. Each session is held for half an hour and three consecutive days.For patients in the control group, the usual care is performed.
Main outcome variables
The post traumatic stress disorder checklist is a commonly used tool for investigating the incidence of post traumatic stress disorder.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180903040935N1
Registration date:2018-11-25, 1397/09/04
Registration timing:registered_while_recruiting
Last update:2018-11-25, 1397/09/04
Update count:0
Registration date
2018-11-25, 1397/09/04
Registrant information
Name
Zohreh Ababaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3417 3503
Email address
mozo16883@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-22, 1397/09/01
Expected recruitment end date
2019-01-21, 1397/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect Of Spiritual Care On Post Traumatic Stress Disorder Following Acute Myocardial Infarction
Public title
The Effect Of Spiritual Care On Post Traumatic Stress Disorder
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
The patient has an acute myocardial infarction, according to a cardiologist's diagnosis.
Being alert.
Speaking in Persian.
Being Muslim.
Have no known mental illness.
Have no mental retardation.
Exclusion criteria:
Unwillingness to continue the study.
Occurrence of a new heart attack.
Occurrence of any severe complications of myocardial infarction (cardiogenic shock and severe heart failure).
The necessity of using a pacemaker and implantable cardioverter defibrillator.
Performing a coronary artery bypass graft surgery.
Patient death.
Displacement of the patient's place of residence.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
The patients will be selected according to inclusion and exclusion criteria and will be randomly divided into intervention and control groups by blocked randomization using computer software.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
Vice-Chancellor for Research, Arak University of Medical Sciences, Basij Square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
3819693345
Approval date
2018-09-23, 1397/07/01
Ethics committee reference number
1397.156
Health conditions studied
1
Description of health condition studied
Acute Myocardial Infarction
ICD-10 code
121
ICD-10 code description
121.0, 121.1, 121.2, 121.3, 121.4, 121.9
Primary outcomes
1
Description
Score of post traumatic stress disorder.
Timepoint
One month after the start of the study.
Method of measurement
Post Traumatic Stress Disorder Checklist.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The participants of the intervention group undergo spiritual need-based program. This program consisted of a 30 minute session per day for 3 consecutive days. The first session focuses on reducing concerns about the future by explaining Truth. In the second session, promotion of self-esteem is considered by explaining self-esteem and eliminating its conflicts. At the third session, emphasis is placed on reducing feelings of guilt and attaining calm. one month later, Post Traumatic Stress Disorder Checklist (PCL) will be completed by patients.
Category
Prevention
2
Description
Control group: Patients in the control group receive routine care. one month later, Post Traumatic Stress Disorder Checklist (PCL) will be completed by patients.