This study aimed to evaluate the effect of spiritual care based on GHALBE SALIM model on spiritual health and quality of life of patients with acute MI. The study is a randomized, non-blinded clinical trial. The study population includes all patients with acute MI hospitalized in Alzahra hospital affiliated to Isfahan University of Medical Sciences. Inclusion criteria: Consent for participation in study; age more than 50 years; diagnosed with acute MI by cardiologist; being Iranian and Shia; being conscious. Exclusion Criteria: Patient's unwillingness to cooperate; experience of stressful events; transfer to other units or hospitals; death. Sample size includes 60 patients. After getting informed consent in test group, they will complete spiritual health and quality of life questionnaires as primary and secondary outcomes. Care-plan based on GHALBE SALIM model (Quad communications reform educations according to GHALBE SALIM model) will implement for them. Finally, aforementioned questionnaires will complete for patients again at the end of the study. Control group is similar to test group but for this group we will not implement care-plan based on GHALBE SALIM model and they will receive routine care.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201606208665N5
Registration date:2016-06-30, 1395/04/10
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-06-30, 1395/04/10
Registrant information
Name
Hassan Babamohamadi
Name of organization / entity
Semnan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 3365 4190
Email address
babamohamadi@sem-ums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research and technology, Semnan University of Medical Sciences
Expected recruitment start date
2016-07-10, 1395/04/20
Expected recruitment end date
2017-09-11, 1396/06/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of spiritual care based on GHALBE SALIM Model on spiritual health and quality of life of patients with Acute MI hospitalized in CCU
Public title
The effect of spiritual care on spiritual health and quality of life
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion Criteria: Consent for participation in study; age more than 50 years; diagnosed as acute MI by cardiologist; Iranian origin and Shia; being conscious. Exclusion Criteria: Patient's unwillingness to cooperate ; experience of stressful events; transfer to other units or hospital; death
Age
From 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Random allocation of subjects to experimental and control groups will be carried out using sealed envelopes in which the letters A or B will be placed.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Semnan University of Medical Sciences
Street address
Semnan University of Medical Sciences, Vice Chancellor for Research and Technology, Basidj Blv, Semnan, Iran
City
Semnan
Postal code
3513138111
Approval date
2016-06-20, 1395/03/31
Ethics committee reference number
IR.SEMUMS.REC.1395.53
Health conditions studied
1
Description of health condition studied
Acute myocardial infarction
ICD-10 code
121
ICD-10 code description
Acute myocardial infarction
Primary outcomes
1
Description
Spiritual Health
Timepoint
At the begining and at end of study
Method of measurement
Palutzian and Ellison spiritual health questionnaire
Secondary outcomes
1
Description
Quality of life
Timepoint
At the begining and at the end of study
Method of measurement
WHOQOL-BRIEF questionnaire
Intervention groups
1
Description
After getting informed consent in test group, they will complete spiritual health and quality of life questionnaires. Spiritual care-plan based on GHALBE SALIM model will implemented for them. This program will be implemented for three day in CCU when patients feel lonely and spiritual issues appear between 17-20 hours and continue for one month after discharge by patients themselves. After one month aforementioned questionnaires will complete for patients again.
Category
Lifestyle
2
Description
After getting informed consent in control group, they will complete spiritual health and quality of life questionnaire. But spiritual care-plan based on GHALBE SALIM model will not implement for them and they will receive only routine nursing care.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan Alzahra Hospital
Full name of responsible person
Hassan Babamohamadi
Street address
CCU, Alzahra Hospital, Isfahan
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Semnan University of Medical Sciences
Full name of responsible person
Dr Ali Rashidypour
Street address
Vice Chancellor of Research and Technology, Semnan University of Medical Sciences, Basidj Blv, Semnan, Iran
City
Semnan
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 Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Hassan Babamohamadi
Position
Assistant Professor
Other areas of specialty/work
Street address
Nursing and Allied Health Faculty, Semnan University of Medical Sciences, 5th Kilometer of Damghan Road, Semnan, Iran
City
Semnan
Postal code
3513138111
Phone
+98 23 3365 4190
Fax
Email
babamohammady2007@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Hassan Babamohamadi
Position
Assistant Professor
Other areas of specialty/work
Street address
Nursing and Allied Health Faculty, Semnan University of Medical Sciences, 5th Kilometer of Damghan Road, Semnan, Iran
City
Semnan
Postal code
3513138111
Phone
+98 23 3365 4190
Fax
Email
babamohammady2007@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Hassan Babamohamadi
Position
Assistant Professor
Other areas of specialty/work
Street address
Nursing and Allied Health Faculty, Semnan University of Medical Sciences, 5th Kilometer of Damghan Road, Semnan, Iran
City
Semnan
Postal code
3513138111
Phone
+98 23 3365 4190
Fax
Email
babamohammady2007@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)