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Investigating the effect of spiritual care based on Sound Heart Model on Spirituality Experience and tendency to Social Desirability in patients with Multiple Sclerosis

Protocol summary

Study aim
Determining the effect of spiritual care based on Sound Heart Model on Spiritual Experience and tendency to Social Desirability in patients with multiple sclerosis
Design
This study is a clinical trial with two groups (intervention and control), no blinding and randomized (simple random allocation) with 40 patients in each group. SPSS software will be used for randomization.
Settings and conduct
This study, will be performed in Kerman Medical Center for Special Diseases. In the intervention group ,16 sessions of spiritual care based on a healthy heart model will be performed in 8 weeks and two sessions per week and virtually. The variables will be measured before and 1 month after the intervention.
Participants/Inclusion and exclusion criteria
Patients with multiple sclerosis/ Inclusion criteria: Failure to mental illness and use of psychotropic drugs, adult patients over 18 years who are not in the acute stage of the disease, no deafness to communicate, definitive diagnosis of MS according to a neurologist, at least 6 months Onset of illness, at least fifth grade education, access to Android or PC phones and the Internet to attend virtual meetings Exclusion criteria: Hospitalization due to recurrence of the disease, other debilitating diseases, participation in spiritual care training sessions in the past year, unwillingness to continue cooperation and incomplete completion of questionnaires more than 10% of all questionnaire questions.
Intervention groups
Intervention group: 16 virtual sessions of 35 minutes of spiritual care based on Sound Heart Model, virtual and through Skyroom, will receive two sessions per week; While patients in the control group receive routine care.
Main outcome variables
Spiritual experience, Tendency to social desirability

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20151107024919N13
Registration date: 2022-03-19, 1400/12/28
Registration timing: prospective

Last update: 2022-03-19, 1400/12/28
Update count: 0
Registration date
2022-03-19, 1400/12/28
Registrant information
Name
Batoul Tirgari
Name of organization / entity
Kerman Medical University of Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 3132 5207
Email address
b_tirgari@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-21, 1401/02/01
Expected recruitment end date
2022-06-22, 1401/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of spiritual care based on Sound Heart Model on Spirituality Experience and tendency to Social Desirability in patients with Multiple Sclerosis
Public title
Effect of spiritual care based on Sound Heart Model on Spirituality Experience and tendency to Social Desirability in patients with Multiple Sclerosis
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Failure to mental illness and use of psychotropic drugs Adult patients over 18 years old who are not in the acute stage of the disease No deafness to communicate Definitive diagnosis of MS according to a neurologist At least 6 months after the onset of the disease At least fifth grade education Access to Android phones or computers and the Internet to participate in virtual meetings
Exclusion criteria:
Hospitalization due to recurrence of the disease Having other debilitating diseases Participation in spiritual care training sessions in the past year Unwillingness to continue collaboration and incomplete completion of questionnaires more than 10% of the total questionnaire questions
Age
From 18 years old
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
Eligible patients will be selected by available sampling method and will be numbered from 1 to 80. Codes 1 to 80 are entered into SPSS software and the software is instructed to randomly select 40 people who will be placed in the intervention group. In order to assign the subjects to the intervention and control groups, a simple random allocation method will be used. Using SPSS software, half of the subjects will be in the intervention group and the other half in the control group (40 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 Kerman University of Medical Sciences
Street address
Medical Center of the Special Disease, No.78 Alley, Shahid Rajaee Street.
City
Kerman
Province
Kerman
Postal code
7619875994
Approval date
2022-02-07, 1400/11/18
Ethics committee reference number
IR.KMU.REC.1400.644

Health conditions studied

1

Description of health condition studied
Multiple Sclerosis
ICD-10 code
G35
ICD-10 code description
Multiple Sclerosis

Primary outcomes

1

Description
Spiritual Experience
Timepoint
The score of spiritual experience will be measured before and 1 month after the end of the intervention.
Method of measurement
Daily Spiritual Experience Scale (DSES) (Underwood & Teresi)

2

Description
Tendency to Social Desirability
Timepoint
The score of tendency to Social Desirability will be measured before and 1 month after the end of the intervention.
Method of measurement
Social Desirability Scale (Crown & Marlow )

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Providing spiritual care based on Sound Heart Model in 16 sessions of 35 minutes for 8 weeks (two sessions per week) virtually through the Sky Room link, by members of the research team in the form of lectures, questions and answers, group discussions, experiences and The use of teaching aids such as PowerPoint, videos and presentation of scenarios, etc. will be implemented for the intervention group. Also, the file of the guide book of patients' spiritual care written by Asad Zandi from the publications of the Academy of Medical Sciences of the Islamic Republic of Iran and the audio and video file of spiritual care training will be provided to them offline via WhatsApp.
Category
Other

2

Description
Control group: Patients in the control group received routine cares.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Medical Center of the Special Diseases
Full name of responsible person
Batool Tirgari
Street address
Medical Center of the Special Disease, No. 78 Alley. Shahid Rajaei Street.
City
Kerman
Province
Kerman
Postal code
7619875994
Phone
+98 34 3271 2001
Fax
+98 34 3271 2127
Email
b_tirgari@kmu.ac.ir
Web page address
http://kmu.ac.ir/fa/snm

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Abbas Pardakhti
Street address
No. 2, Research and Technology Depart, Ibn Sina St, Kerman
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3121 7213
Email
abpardakhty@kmu.ac.ir
Web page address
http://kmu.ac.ir/fa/vcrt
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Batool Tirgari
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Kerman University of Medical sciences, Medical University Campus, Haft-Bagh-Alawi Highway, Kerman
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5207
Fax
+98 34 3132 5184
Email
b_tirgari@kmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Batool Tirgari
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Kerman University of Medical sciences, Medical University Campus, Haft-Bagh-Alawi Highway, Kerman
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5207
Fax
+98 34 3132 5184
Email
b_tirgari@kmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Batool Tirgari
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Kerman University of Medical sciences, Medical University Campus, Haft-Bagh-Alawi Highway, Kerman
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5207
Fax
+98 34 3132 5184
Email
b_tirgari@kmu.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
Not applicable
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