Protocol summary
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Study aim
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The effect of spiritual counseling on happiness and hope in patients with multiple sclerosis
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Design
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Samples were divided into intervention and control groups using block randomization method.
Sample size was obtained by considering 95% confidence interval and 90% test power using the results of other similar studies 21 individuals in each group.
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Settings and conduct
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Intervention group will participate in 8 sessions of 60 minutes and two sessions per week for one month. Spiritual counseling sessions are held in a group setting at the community building.
The content of these meetings has been approved by religious and university experts.
The content is presented in a lecture and team work manner by a psychiatrist familiar with the patient consultation and communication skills and whose qualifications have been approved by the Department of Psychology of Kashan University of Medical Sciences.
also the homework about the subject of session are given to Patient to do at home and report in the next session.
And the control group will remain intact and no spiritual counseling intervention will be provided.
Happiness and hope status was measured in both groups, once immediately after the end of the spiritual counseling program for the intervention group and again one month later for follow-up by the research instrument.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Diagnosis of MS by a specialist physician and physical ability to attend sessions
Exclusion criteria: Cognitive disorder and Unwillingness to participate in the study
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Intervention groups
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Intervention group includes patients with multiple sclerosis who receive spiritual counseling intervention.
The control group includes patients with multiple sclerosis who will receive no intervention and will remain intact.
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Main outcome variables
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Happiness and hope status
General information
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Reason for update
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correction of recruitment start and end date according to approval date of ethics committee
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20190819044567N1
Registration date:
2020-01-30, 1398/11/10
Registration timing:
prospective
Last update:
2020-02-10, 1398/11/21
Update count:
1
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Registration date
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2020-01-30, 1398/11/10
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2020-02-05, 1398/11/16
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Expected recruitment end date
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2020-02-14, 1398/11/25
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The Effect Of Spiritual Counseling On Happiness And Hope Among Patients With Multiple Sclerosis
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Public title
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The Effect Of Spiritual Counseling On Happiness And Hope Among M.S Patients
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Purpose
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Education/Guidance
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Inclusion/Exclusion criteria
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Inclusion criteria:
All patients with multiple sclerosis who have been diagnosed for three months
Ability to commute and attend sessions
Iranian Citizenship and Residence in Kashan
Exclusion criteria:
Cognitive disorder
Unwillingness to participate in the study
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Age
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No age limit
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
48
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Block randomization and do it online by using https://www.sealedenvelope.com website
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2019-12-21, 1398/09/30
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Ethics committee reference number
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IR.KAUMS.NUHEPM.REC.1398.062
Health conditions studied
1
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Description of health condition studied
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Multiple Sclerosis
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ICD-10 code
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G35
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ICD-10 code description
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Multiple sclerosis
Primary outcomes
1
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Description
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Happiness Score
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Timepoint
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Before the intervention and immediately thereafter and one month later
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Method of measurement
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Oxford Happiness Questionnaire
2
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Description
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Hope Score
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Timepoint
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Before the intervention and immediately thereafter and one month later
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Method of measurement
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Herth Hope Scale
Intervention groups
1
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Description
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The content of spiritual counseling sessions is as follows:First Session:• Self-knowledge and understanding of your strengths& weakness, fears, needs and desires• Realistically understand your limitations, shortcomings and disabilities as part of yourself• Accept mistakes and gain experience as a factor in increasing self-esteem and empowerment Second Session:• Acceptance of the God's Divinity and the right of man to determine his own destiny• Consolidation of God's wise will based on the causal system• The wisdom of having human illness Third Session:• Repentance and confession of sins to God and acceptance of your weaknesses• Trying to relax and improve your health and life with hope and positive thoughts• The love of God for His servants and his promise to forgive and ignore human mistakes • The need to reform behaviors and the past to move towards the future Fourth Session:• Emotion control training, emotion regulation techniques, relaxation training, etc.• Understanding your feelings and ways to express your feelings• Expressing repressed and undesirable feelings• having a purpose as a key factor in enjoying life despite illness Fifth Session:• Deep knowledge of the self, in order to realize its enormous and hidden abilities• Recognize your weaknesses and try to fix them• Taking advantage of hope and not succumbing to hopelessness and Avoidance of self-defeat• Avoid comparing yourself with others• Reliance on yourself and your abilities and avoiding unnecessary dependence on others.Sixth Session:• Thought control due to the extraordinary power of thought creation or destruction• Take advantage of the sad events in life instead of despair and worry, according to a bit of Saadi, “Where one door shuts another opens”.• Modeling successful people Seventh Session:• How to be empowered to solve your own and others problems• Psycho-cognitive empowerment by: Feeling Competent, confident, effective, autonomy and meaningful Eighth Session:• Awareness and belief that the origin of human happiness is his or her own.• Being responsible for life in order to respond appropriately• Control of psychological reactions as an effective factor in physical diseases• Reviewing and summarizing course content
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Category
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Lifestyle
2
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Description
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Control group: No intervention
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Category
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Lifestyle
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Kashan University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available