Effect of Spiritual Training on Quality of Life on Multiple Sclerosis Patients
Design
Clinical trials with control group, Community based on, randomized
Settings and conduct
Semi-experimental study was performed on two groups of interventional type based on the pre-test and post-test design. 80 patients from the Ahvaz MS Society were selected, demographic information form and quality of life questionnaire and spiritual health were given in the form of pretest. Then, patients A randomized study was conducted in two groups of 40 (test and control). Interaction training was done face to face, lecture, question and answer in 5 sessions of 60 minutes.
Participants/Inclusion and exclusion criteria
Entry requirements
ability speak persian
Age Over 18 Years
Confirmed Diagnosis of Multiple Sclerosis disease
Passed at least three months after diagnosis
The Disease is in Stage 3-4
Having a low or moderate quality of life score
He or she has no cognitive impairment or other chronic illness
Patients just have MS and they Are not in Acute Phase
Having a Low Score of Spiritual Health
Conditions of failure to enter
Participation in Spirituality Classes Except Current Study
A disease that is due to recurrence of the disease during the study in the hospital
In the absence of more than one session
Intervention groups
Research Contain Two Experimental and Control Groups that Experimental Group will Spiritual Training in (intervention) in Five 60-minute sessions But Control Group Do Not
Main outcome variables
The Spiritual Health and Quality of Life of MS patients are the main variables of the research.
General information
Reason for update
Acronym
MS
IRCT registration information
IRCT registration number:IRCT20160622028581N2
Registration date:2018-09-26, 1397/07/04
Registration timing:retrospective
Last update:2018-09-26, 1397/07/04
Update count:0
Registration date
2018-09-26, 1397/07/04
Registrant information
Name
Razie Noroozi
Name of organization / entity
The university of jundishapur Ahvaz
Country
Iran (Islamic Republic of)
Phone
+98 61 3373 8621
Email address
noroozi.r@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-06-21, 1395/04/01
Expected recruitment end date
2016-08-21, 1395/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Spiritual Training on Quality of Life on Multiple Sclerosis Patients
Public title
Effect of Spiritual Training on MS Patients.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Introduction to Persian Falconer
Age Over 18 Years
Confirmed Diagnosis of Multiple Sclerosis Risk
Over Three Months From the Time of Diagnosis
The Disease is Stage 3-4
Having Poor Quality of LifeScore (Score Between 29 to 58) or Moderate (Score Between ages 58 and 87)
Is Not Suffering With Cognitive Disorders or Other Chronic Disease
Patients Except for MS Patient Havenot Other Diseases and People Arenot in Acute Phase.
Having a Low Score of Spiritual Health (20-40)
Exclusion criteria:
Participation in Spirituality Classes Except Current Study
Patients Who are Hospitalized During the Study Due to Disease Recurrence
If More Than One Session Away
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
Personal Selected in Experimental and Control Groups Was Simple Randomly that By Randomly Numbers Table.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
80 patients from the Ahvaz MS Society were selected, demographic information form and quality of life questionnaire and spiritual health were given in the form of pretest. Then, patients A randomized study was conducted in two groups of 40 (test and control)
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jundishapur University of Medical Sciences
Street address
University Blvd., Golestan
City
Ahvaz
Province
Khouzestan
Postal code
15794- 61357
Approval date
2016-04-23, 1395/02/04
Ethics committee reference number
IR.AJUMS.REC.1395.59
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
Quality of Life Primary outcome Variable
Timepoint
Measurement of Quality of Life of MS Patients in the Beginning of the Study (Before Intervention) and 5 Weeks After (After the Intervention) and 3 Months After the End of the Intervention
Method of measurement
Questionnaire Assessing the `Quality of Life of MS Patients
2
Description
Spiritual Health as Another Variable is The Primary Consequence of This Research
Timepoint
Measurement of Spiritual Health of MS Patients in the Beginning of the Study (Before Intervention) and 5 Weeks After (After the Intervention) and 3 Months After the End of the Intervention
Method of measurement
Pulotzin and Ellison Spiritual Health Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention group of Spirituality is grouped in 5 sessions as follows: First session: Introduction of spiritual intervention sessions and familiarization with the rules of the group; Second session: Contact with God; Third session: Contact with yourself; Fourth session: Relationship with Others and Nature and Fifth Session: Explaining the Experience of Spiritual Training and Its Effects and Preparing Members to leave the group and use its achievements
Category
N/A
2
Description
Control group: The control group did not receive any intervention.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Ahvaz Mystic Society
Full name of responsible person
Dr. Nastaran Majdi Nasab
Street address
Room 151,College of Rehabilitation. Jundishapur University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3374 3660
Email
Noroozi.r@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr. Nasrin Elahi
Street address
No. 159, Golestan BVL, Ahvaz Jundishapur University of Medical Sciences, Iran
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3333 2368
Email
noroozi.r@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Razie Noroozi
Position
Master Student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No. 68, West Mihan Ave., Kianpars
City
Ahvaz
Province
Khouzestan
Postal code
6155656489
Phone
+98 61 3333 5896
Email
noroozi.r@ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Razie Noroozi
Position
Master Student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No. 68, West Mihan Ave., Kianpars
City
Ahvaz
Province
Khouzestan
Postal code
6155656489
Phone
+98 61 3333 5896
Email
noroozi.r@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Razie Noroozi
Position
Master Student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No. 68, West Mihan Ave., Kianpars
City
Ahvaz
Province
Khouzestan
Postal code
6155656489
Phone
+98 61 3333 5896
Email
noroozi.r@ajums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Because of ethical considerations, I'm not able to publish the participant data file.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not 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