Comparing the Effect of Spiritual Intelligence Education based on Teach-back Method with routine cares on Quality of Life and Psychological Adjustment in post-MI patients
Determining the effect of spiritual intelligence education based on the Teach-back Method on quality of life and psychological adjustment in post-MI patients in Rania hospitals in 2021-2022.
Design
A clinical trial with a parallel, randomized, and control group will be performed on 80 heart patients. The sample size will be considered 40 patients for each group in this study. Participants will be randomly divided into intervention and control groups, and a random number table will be used for randomization.
Settings and conduct
The study location will be the CCU ward of RANYA Hospital in Sulaymaniyah, Iraq. The study population will be all patients after myocardial infarction (Post MI), and there will be no blindness in our study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Post-MI patients; being conscious and well-oriented; ability to read and write.
Exclusion criteria: Patients with psychiatric disorders
Intervention groups
The control group will receive routine hospital care.
The intervention group will receive seven sessions of Intelligence Education based on the Teach-back Method.
Main outcome variables
Quality of Life; Psychological Adjustment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20131112015390N6
Registration date:2022-04-04, 1401/01/15
Registration timing:registered_while_recruiting
Last update:2022-04-04, 1401/01/15
Update count:0
Registration date
2022-04-04, 1401/01/15
Registrant information
Name
Naser Parizad
Name of organization / entity
Urmia University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 44 1348 7649
Email address
parizad.n@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-03-02, 1400/12/11
Expected recruitment end date
2022-09-01, 1401/06/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the Effect of Spiritual Intelligence Education based on Teach-back Method with routine cares on Quality of Life and Psychological Adjustment in post-MI patients
Public title
The Effect of Spiritual Intelligence Education based on Teach-back Method on Quality of Life and Psychological Adjustment
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Post MI patients
Being conscious and fully oriented
Ability to read and write
Exclusion criteria:
Patients with psychiatric disorders
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
The participants will be randomly allocated into two intervention and control groups based on pre-designated numbers obtained from Random Number Table. Sealed envelopes and sequential numbers will be used to conceal random allocation. In this method, each series of random numbers created by the random number table will be written on a card and the cards will be placed in envelopes. Eventually the sealed envelopes will be placed inside the box. One number is assigned to each patient and his/her name will be recorded on the envelope before unsealing.
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
Research Ethics Committees of Urmia University of Medical Sciences
Street address
School of Nursing and Midwifery; Nazloo Campus; 11 km of Seru Road; Urmia; West Azarbaijan
City
Urmia
Province
West Azarbaijan
Postal code
57561-15335
Approval date
2022-03-02, 1400/12/11
Ethics committee reference number
IR.UMSU.REC.1400.468
Health conditions studied
1
Description of health condition studied
Acute myocardial infarction
ICD-10 code
I21
ICD-10 code description
ST elevation (STEMI) and non-ST elevation (NSTEMI) myocardial infarction
Primary outcomes
1
Description
Quality of Life
Timepoint
At the beginning of the study (before the intervention) and after the intervention
Method of measurement
The MacNew quality of life after myocardial infarction (MacNew QLMI) questionnaire.
Secondary outcomes
1
Description
Psychological Adjustment
Timepoint
At the beginning of the study (before the intervention) and after the intervention
Method of measurement
The psychological adaptation scale (PAS).
Intervention groups
1
Description
Intervention group: The study will be conducted at Rania Hospital in Iraq. In addition to the routine hospital care that the patients will receive in the control group, seven training sessions based on the teach-back method will be considered for patients in the intervention group, and patients will receive two 60-minute sessions each week for a month. It should be noted that the training will be conducted individually. In the first session, patients are taught about awareness. The second patient education session will be based on the meaning of life, and the third session will be about evaluation. Then, we will continue the training until the end according to the King training program. The last session will focus on topics that patients have not understood, key points, and repetition with short sentences.
Category
Rehabilitation
2
Description
Control group: This group will receive the hospital's routine care.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Ranya General Hospital, Sulaymaniyah, Iraq.
Full name of responsible person
Chawan Pirot Abubakr
Street address
7V5H+2M3, Ranya, Iraq
City
Ranya
Postal code
57561-15335
Phone
+964 770 156 6507
Email
Zhwangul.pirot@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Saber Gholizadeh
Street address
UMSU Central Site; Orjhans Street; Resalat Blvd.; Urmia.
City
Urmia
Province
West Azarbaijan
Postal code
571478334
Phone
+98 44 3193 7224
Fax
+98 44 3224 0642
Email
parizad.n@umsu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Oroumia 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
Oroumia University of Medical Sciences
Full name of responsible person
Naser Parizad
Position
assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery; Nazloo Campus; 11 km of Seru Road; Urmia; West Azarbaijan; Iran.
City
Urmia
Province
West Azarbaijan
Postal code
57561-15335
Phone
+98 44 3275 4961
Fax
+98 44 3275 4961
Email
parizad.n@umsu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Naser Parizad
Position
assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Others
Street address
School of Nursing and Midwifery; Nazloo Campus; 11 km of Seru Road; Urmia; West Azarbaijan; Iran.
City
Urmia
Province
West Azarbaijan
Postal code
57561-15335
Phone
+98 44 3275 4961
Fax
+98 44 3275 4921
Email
parizad.n@umsu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Naser Parizad
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery; Nazloo Campus; 11 km of Seru Road; Urmia; West Azarbaijan; Iran.
City
Urmia
Province
West Azarbaijan
Postal code
57561-15335
Phone
+98 44 3275 4961
Fax
+98 44 3275 4921
Email
parizad.n@umsu.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