Protocol summary

Summary
This study is a randomized control trial to determine the effects of Spiritual-Religious care on depression intensity in women with multiple sclerosis. All of the multiple sclerosis female patients, who were referred to Iran MS associations, were our statistical research community. Of them, 70 patients were selected based on inclusion criteria included: being Muslim, not participated in previous training programs about Spiritual-Religious care and Spiritual counseling in Last three months, Patients suffering from moderate level of disease according to disability intensity and symptoms and they were randomly divided into two experimental and control groups using table of random numbers. Religious spiritual care sessions were held according to Richard Burgin pattern for the intervention group in the form of group education, in seven sessions. Depression intensity was the main outcome and therefore patients filled oud Beck Depression Inventory before and after the intervention.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016112731125N1
Registration date: 2017-01-04, 1395/10/15
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-01-04, 1395/10/15
Registrant information
Name
Saeideh Khalili Senobari
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2218 0036
Email address
khalili.senobar@gmail.com
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, University of Social Welfare and Rehabilitation sciences
Expected recruitment start date
2016-06-21, 1395/04/01
Expected recruitment end date
2016-09-22, 1395/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of Spiritual-Religious care on Depression intensity in women with multiple sclerosis
Public title
The effects of Spiritual-Religious care on Depression intensity
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Multiple sclerosis confirmed by a neurologist; Consent to participate in research and having cooperation; not participated in previous training programs about Spiritual-Religious care and Spiritual counseling in Last three months; Patients suffering from moderate level of disease according to disability intensity and symptoms; Ability to communicate effectively with researcher; ability to handle meetings and prepared to respond to questions physically and mentally; Minimum 20 and maximum 45 years old; having the ability to read and write and be able to speak Persian; be Muslims and having disease for at least 6 months. Exclusion criteria: withdrawal to continue cooperation; being in the recurrence of the disease and inability to attend in the meetings.
Age
No age limit
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Table of random numbers was used For randomization

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of University of Social Welfare and Rehabilitation sciences
Street address
Koodakyar Avenue, Daneshjoo Blvd, Evin, Tehran
City
Tehran
Postal code
1985713834
Approval date
2016-08-10, 1395/05/20
Ethics committee reference number
IR.USWR.REC.1395.45

Health conditions studied

1

Description of health condition studied
Multiple sclerosis
ICD-10 code
G35
ICD-10 code description
Demyelinating diseases of the central nervous system

Primary outcomes

1

Description
Depression
Timepoint
before and one month after intervention
Method of measurement
Beck Depression Inventory

Secondary outcomes

1

Description
---
Timepoint
---
Method of measurement
---

Intervention groups

1

Description
Intervention group: the patients in this group received religious spiritual care in 7 sessions of 45 to 60 minutes, based on Richards and Bergin model and in the form of group education including book therapy, Understanding of forgiveness and spirituality and self-observing.
Category
Other

2

Description
Control group: There was no intervention
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Iranian MS society
Full name of responsible person
Saeideh Khalili Senobari
Street address
Koodakyar Avenue, Daneshjoo Blvd, Evin, Tehran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, University of Social Welfare and Rehabilitation sciences
Full name of responsible person
Dr.Hamidreza Khankeh
Street address
Koodakyar Avenue, Daneshjoo Blvd, Evin, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, University of Social Welfare and Rehabilitation sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
University of Social Welfare and Rehabilitation sciences
Full name of responsible person
Saeideh Khalili Senobari
Position
Master Student of Nursing
Other areas of specialty/work
Street address
Koodakyar Avenue, Daneshjoo Blvd, Evin, Tehran
City
Tehran
Postal code
Phone
+98 21 2218 0036
Fax
Email
saide.94.khalili@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of Social Welfare And Rehabilitation sciences
Full name of responsible person
Masoud Fallahi khoshknab
Position
PhD of nursing
Other areas of specialty/work
Street address
Koodakyar Avenue, Daneshjoo Blvd, Evin, Tehran
City
Tehran
Postal code
Phone
+221 80036
Fax
Email
msflir@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
University of Social Welfare and Rehabilitation sciences
Full name of responsible person
Saeideh Khalili Senobari
Position
Master student of nursing
Other areas of specialty/work
Street address
Koodakyar Avenue, Daneshjoo Blvd, Evin, Tehran
City
Tehran
Postal code
Phone
+98 21 2218 0036
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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