The effect of spiritual care based on healthy Sound Heart Model on post traumatic stress disorder and anxiety of family caregivers of patients with myocardial infarction.
The effect of spiritual care based on a healthy heart pattern on post-traumatic stress disorder and anxiety of family caregivers with myocardial infarction.
Design
Clinical trial with control group, with parallel groups, without blinding, randomized, phase 3 on 80 patients. Blocking method and Randomization.com online software were used for randomization.
Settings and conduct
In this study, 80 companions of patients with acute myocardial infarction hospitalized in Arak hospitals will be included in the study. After randomization, post-traumatic stress and anxiety of patients' companions will be evaluated and in the intervention group will be under spiritual care for 4 days and the control group will be under routine hospital care. The patients' companions will then be re-evaluated after one month. Blinding is not performed in this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: First-degree relatives of patients with acute myocardial infarction, aged 18 to 70 years. Exclusion criteria: suffering from psychiatric illnesses, suffering from chronic and debilitating illnesses.
Intervention groups
Family caregivers of the intervention group receive face-to-face and individual spiritual care of the healthy heart face-to-face and individually by the trained researcher in all sessions on all days of hospitalization for 8 sessions for 10 to 20 minutes. . In the control group, patients receive routine hospital care. For example, when they have questions, their questions will be answered and an educational pamphlet will be provided to them.
Main outcome variables
Post traumatic stress disorder, anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190717044255N5
Registration date:2022-04-20, 1401/01/31
Registration timing:prospective
Last update:2022-04-20, 1401/01/31
Update count:0
Registration date
2022-04-20, 1401/01/31
Registrant information
Name
Ali Azizi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3276 7500
Email address
a.azizi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-05, 1401/02/15
Expected recruitment end date
2022-06-21, 1401/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of spiritual care based on healthy Sound Heart Model on post traumatic stress disorder and anxiety of family caregivers of patients with myocardial infarction.
Public title
The effect of spiritual care on post-traumatic stress
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
First-degree relatives of the patient who was with the patient during the first 6 hours of the heart attack
Age 18 to 70 years
Exclusion criteria:
Having psychiatric illnesses
Chronic and debilitating diseases
Age
From 18 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
80 patients with inclusion criteria will be divided into two groups of intervention and control using block randomization method in 10 blocks of 8 using online blocking software Randomization.com. Concealment in this study will be sealed using the envelope method. In this way, a number of envelopes with aluminum wrappers are prepared and each of the random sequences created is registered on a card and the cards are placed inside the envelopes. In order to maintain a random sequence, envelopes are numbered in the same way on the outer surface. At the beginning of the registration of participants, one of the envelopes of the letter is opened in order and the assigned group of that participant is revealed.
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 Arak University of Medical Sciences
Street address
Payambar-e-azam Complex, Sardasht Town
City
Arak
Province
Markazi
Postal code
3848176341
Approval date
2022-03-13, 1400/12/22
Ethics committee reference number
IR.ARAKMU.REC.1400.351
Health conditions studied
1
Description of health condition studied
Post Traumatic Stress Disorder
ICD-10 code
F43.1
ICD-10 code description
Post-traumatic stress disorder (PTSD)
2
Description of health condition studied
Anxiety
ICD-10 code
F06.4
ICD-10 code description
Anxiety disorder due to known physiological condition
Primary outcomes
1
Description
Anxiety
Timepoint
Before the intervention and one month after the intervention
Method of measurement
Depression Anxiety Stress Scale
2
Description
Post traumatic Stress Disorder
Timepoint
Before the intervention and one month after the intervention
Method of measurement
The Post traumatic Stress Disorder Checklist for Diagnostic and Statistical Manual of Mental Disorders-5
Secondary outcomes
empty
Intervention groups
1
Description
Control group: 40 patient's companions receive routine hospital care as a control group. For example, when they have questions, their questions will be answered and educational pamphlets will be provided to them.
Category
Behavior
2
Description
Intervention group: 40 patients as an intervention group on all days of hospitalization and during 8 sessions for 10 to 20 minutes and during 4 days (two sessions per day, one morning session and one evening session), receive spiritual care based on the healthy Sound Heart model, face to face and individually, by a trained researcher.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Amirkabir hospital
Full name of responsible person
Rezvan Mirzaei
Street address
Payambar-e-azam Complex, Sardasht Town
City
Arak
Province
Markazi
Postal code
3848176943
Phone
+98 918 764 5637
Email
research@arakmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Alireza Kamali
Street address
Payambar-e-azam Complex, Sardasht Town
City
Arak
Province
Markazi
Postal code
3848176341
Phone
+98 86 3417 3639
Email
research@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Rezvan Mirzaei
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Payambar-e-azam Complex, Sardasht Town
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3524
Email
nursing.school@arakmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Rezvan Mirzaei
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Payambar-e-azam Complex, Sardasht Town
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3524
Email
nursing.school@arakmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Rezvan Mirzaei
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Payambar-e-azam Complex, Sardasht Town
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3524
Email
nursing.school@arakmu.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