The effect of a program based on spiritual care on self-esteem and spiritual health of patients with thalassemia major referred to Seyed Al-Shohada Hospital in Isfahan, 2022
Determining the effect of a program based on spiritual care on self-esteem and spiritual health of patients with beta thalassemia major referred to Seyed Al-Shohada Hospital in Isfahan province in 2022
Design
A clinical trial with the control group, no blinding, randomized, on 64 patients. Excel random function was used for randomization.
Settings and conduct
Patients with beta-thalassemia major in Seyed Al-Shohada Hospital of Isfahan province who are willing to participate in the study and inclusion criteria are identified and randomly entered into the study. In the first stage, their self-esteem and spiritual health are assessed and recorded using a questionnaire, then a program based on spiritual care is presented to the intervention group, then in the last session or up to two weeks later. From the last session of the program based on spiritual care, self-esteem and spiritual health of patients are reviewed and recorded using a questionnaire.
Participants/Inclusion and exclusion criteria
Age range 18 years and older.
Be physically and mentally ready to participate.
Have the ability to read and write in Persian.
Be able to speak Persian.
Absence from another similar study.
Intervention groups
The intervention includes the implementation of a spiritual care program and its impact on the self-esteem and spiritual health of the intervention group. The implementation of this program is in the form of face-to-face classes and in this study in the control group only the level of self-esteem and spiritual health is examined and no intervention is done for the control group.
Main outcome variables
Self-esteem; level of the spiritual health
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211121053121N3
Registration date:2022-02-26, 1400/12/07
Registration timing:registered_while_recruiting
Last update:2022-02-26, 1400/12/07
Update count:0
Registration date
2022-02-26, 1400/12/07
Registrant information
Name
Seyed Abbas Hoseini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 7504
Email address
a_hoseini@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-20, 1400/12/01
Expected recruitment end date
2022-03-19, 1400/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of a program based on spiritual care on self-esteem and spiritual health of patients with thalassemia major referred to Seyed Al-Shohada Hospital in Isfahan, 2022
Public title
The effect of a program based on spiritual care on self-esteem and spiritual health of patients with thalassemia major
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with thalassemia major
Ability to read and write in Persian
Ability to speak Persian
Exclusion criteria:
Reluctance to cooperate in further study.
Participate in a similar study.
Absence from more than one session in training sessions.
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
The sample consisted of 64 patients with beta-thalassemia major. First, a list of all patients with beta-thalassemia major will be provided. By easy sampling method, 64 of these patients were selected and then the samples were randomly divided into two groups of intervention (spiritual care) and control (32 people in each group).
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 Isfahan University of Medical Sciences
Street address
Hezarjerib Ave.,Isfahan Town
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2021-12-25, 1400/10/04
Ethics committee reference number
IR.MUI.NUREMA.REC.1400.197
Health conditions studied
1
Description of health condition studied
Thalassemia
ICD-10 code
D56.1
ICD-10 code description
Beta thalassemia
Primary outcomes
1
Description
Patient self-esteem score in the spiritual self-esteem questionnaire
Timepoint
Before the intervention and 0 to 14 days after the last training session
Method of measurement
Spiritual Self-Esteem Questionnaire of Farhoush
2
Description
Patient's spiritual health score on the Pulotzin and Ellison Spiritual Health Questionnaire
Timepoint
Before the intervention and 0 to 14 days after the last training session
Method of measurement
Pulotzin and Ellison Spiritual Health Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group. The mentioned care program during 6 sessions, each session of 60 minutes in groups of 5-6 people in the educational classes located in Seyed Al-Shohada Hospital in the morning and evening shifts by the researcher in the form of lectures, discussions and exchanges, video clips (using networks Valid authorized download according to the educational content) and the presentation of a spiritual package for the intervention group will be held. All sessions of this spiritual care program are conducted by the researcher and under spiritual consultation with the spiritual care specialists of Ala Center. Intervention in the group is explained by a spiritual cognitive approach. In this approach, much emphasis is placed on expressing concepts operationally. Much of the treatment is based on the here and now approach. The main goal of treatment is to help the patient to change his attitude and reduce negative thoughts about himself, the world and the future. The group intervention program is content-oriented and tries to change and correct patients 'attitudes in four areas of relationship with God, self, others and nature in order to increase patients' hope. Since prayer is sometimes used as a confrontation It is used religiously, if looking at prayer is instrumental and problem-oriented, one uses prayer only when there is a problem; But in a comprehensive, innovative and functionalist view, prayer is a cognitive model that attention to its content and concept, can change the attitude of the individual to himself, God, creation and existence. With such a view of prayer, this intervention helps to raise hope in patients.
Category
Rehabilitation
2
Description
Control group. The control group will not receive any intervention.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Seyed Al-Shohada Hospital
Full name of responsible person
Mehran Sharifi
Street address
Motahari Ave.,Isfahan
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3235 0210
Email
omid@mui.ac.ir
Web page address
https://omid.mui.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mansour Siavash Dastjerdi
Street address
Hezar Jerib Ave., Isfahan., Iran
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3792 3060
Email
siavash@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Seyed Abbas Hosseini
Position
Instructor of Nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Hezar Jerib Ave, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 7153
Email
a_hoseini@nm.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Seyed Abbas Hoseini
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Hezar Jerib street, Isfahan, Iran 8174673461
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7504
Fax
Email
a_hoseini@nm.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Seyed Abbas Hoseini
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Hezar Jerib street, Isfahan, Iran 8174673461
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7504
Fax
Email
a_hoseini@nm.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Part of the data, such as information about the main outcome, can be shared.
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Coordinating with the researcher and observing ethical principles in research
From where data/document is obtainable
Seyed Abbas Hosseini
a_hoseini@nm.mui.ac.ir
03137927504
What processes are involved for a request to access data/document
Correspondence from the center of origin and determine the goals and how to use the data