Determining the effect of religious care education on spiritual health and life expectancy of patients with thalassemia major
Design
A clinical trial with a control group, without blinding, randomized, on 34 patients, the lottery method was used for randomization.
Settings and conduct
This study will be performed on 34 patients with thalassemia major in the thalassemia ward of Ali Asghar Hospital. Religious care in these patients will be done in 6 sessions and spiritual health and life expectancy questionnaires will be filled in before and after the intervention.
Participants/Inclusion and exclusion criteria
Patients with thalassemia major referred to the thalassemia ward of Hazrat Ali Asghar Hospital
Inclusion criteria: - Conscious consent to participate in the study - Have a minimum literacy -Having a record in the thalassemia ward -age between 15-20 years
Conditions for not entering the study:Having severe and chronic diseases such as cancer that make it impossible to participate in the study
Drug addiction (false impact on research units)
Reluctance to participate in the study
Severe mental illness and severe frustration
Intervention groups
For the intervention group, spiritual care training will be done in 6 sessions of 60-45 minutes in groups and in 3 weeks in the morning shift. The content of spiritual care education will be prepared with the focus on topics such as trust, recourse, patience, prayer, supplication and prayer, self-knowledge, communication with God always, reconciliation with people and communication with others. . No intervention will be performed for the control group
Main outcome variables
Life expectancy; mental health
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200606047670N2
Registration date:2021-01-08, 1399/10/19
Registration timing:registered_while_recruiting
Last update:2021-01-08, 1399/10/19
Update count:0
Registration date
2021-01-08, 1399/10/19
Registrant information
Name
sadegh dehghanmehr
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3344 2481
Email address
sa.dehghanmehr@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-20, 1399/09/30
Expected recruitment end date
2021-02-17, 1399/11/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating if the effect of religious care education on spiritual health and life expectancy in adolescents with thalassemia major
Public title
Investigating the effect of religious education in thalassemia
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 15-20
Willingness to participate in the study
Have undergone blood transfusion at least once every 6 months and at least once a week
Having a thalassemia medical record
Have a minimum literacy
Exclusion criteria:
Severe and chronic diseases such as cancer that can not be studied
Drug addiction (false impact on research units)
Severe mental illness and severe frustration
Age
From 15 years old to 20 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
34
Randomization (investigator's opinion)
Randomized
Randomization description
The sampling method will be done randomly and using a lottery among patients who will be eligible to enter the study. In this way, the number will be written in the number of sample units and placed in a bag, and patients who choose odd numbers will be in the intervention group and patients who choose an even number will be in the control group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Zahedan University of Medical Sciences
Street address
Health Street
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816913396
Approval date
2020-09-19, 1399/06/29
Ethics committee reference number
IR.ZAUMS.REC.1399.321
Health conditions studied
1
Description of health condition studied
Beta Thalassemia
ICD-10 code
D56.1
ICD-10 code description
Beta thalassemia
Primary outcomes
1
Description
Life expectancy score in Schneider life expectancy questionnaire
Timepoint
Measuring life expectancy at the beginning of the study (before the intervention) and 35 days later (3 weeks of the intervention and 2 weeks after)
Method of measurement
Schneider life expectancy questionnaire questionnaire
2
Description
Spiritual health score in Pultezin spiritual health questionnaire
Timepoint
Measuring spiritual health at the beginning of the study (before the intervention) and 35 days later (3 weeks of the intervention and 2 weeks after)
Method of measurement
Poltzin Spiritual Health Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: For the intervention group, spiritual care training will be done in 6 sessions of 60-45 minutes in groups and in 3 weeks in the morning shift. The content of spiritual care education will be prepared with the focus on topics such as trust, recourse, patience, prayer, supplication and prayer, self-knowledge, communication with God always, reconciliation with people and communication with others.
Category
Behavior
2
Description
Control group: There will be no intervention for the control group and they will receive their routine care as before.(Counseling by the center itself, which is usually done once a month and has no effect on the study.)
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Thalassemia ward of Hazrat Ali Asghar Hospital
Full name of responsible person
Sadegh Dehghanmehr
Street address
Health Street
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816913396
Phone
+98 54 3344 2481
Email
sadeghdehghan3407@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Ali Navidian
Street address
Health Street
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816913396
Phone
+98 54 3344 2481
Email
alinavidian@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan 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
Zahedan University of Medical Sciences
Full name of responsible person
Sadegh Dehghanmehr
Position
Instructor, Faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Health Street
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816913396
Phone
+98 54 3344 2481
Email
sadeghdehghan3407@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Sadegh Dehghanmehr
Position
Instructor, Faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Health Street
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816913396
Phone
+98 54 3344 2481
Email
sadeghdehghan3407@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Sadegh Dehghanmehr, Instructor, Faculty member
Position
Instructor, Faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Health Street
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816913396
Phone
+98 54 3344 2481
Email
sadeghdehghan3407@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Not applicable
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The article and the plan that will be done will be available except for the patients' information
When the data will become available and for how long
After doing the work and printing the article
To whom data/document is available
All interested people
Under which criteria data/document could be used
In order to be used for further research and supportive treatment of patients
From where data/document is obtainable
Sadegh Dehghan Mehr, Postal Code: 9816913396, Email: sadeghdehghan3407@gmail.com
What processes are involved for a request to access data/document