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Evaluation The Effect Of The Fordyce Happiness Program On sleep Quality,Spiritual Well-Being ,and Pain In Peoples With Multiple Sclerosis

Protocol summary

Study aim
Design
Settings and conduct
Participants/Inclusion and exclusion criteria
Intervention groups
Main outcome variables

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20091215002861N11
Registration date: 2017-12-12, 1396/09/21
Registration timing: retrospective

Last update: 2017-12-12, 1396/09/21
Update count: 0
Registration date
2017-12-12, 1396/09/21
Registrant information
Name
Reza Masoodi
Name of organization / entity
Nursing department, Shahrekord University of Medical Science,
Country
Iran (Islamic Republic of)
Phone
+98 38 1333 5654
Email address
masoodi@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research of Shahrekord University of Medical Sciences
Expected recruitment start date
2016-09-22, 1395/07/01
Expected recruitment end date
2016-12-21, 1395/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation The Effect Of The Fordyce Happiness Program On sleep Quality,Spiritual Well-Being ,and Pain In Peoples With Multiple Sclerosis
Public title
Evaluation The Effect Of The Fordyce Happiness Program On sleep Quality,Spiritual Well-Being ,and Pain In Peoples With Multiple Sclerosis
Purpose
Supportive
Inclusion/Exclusion criteria
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
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

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethic commite of Shahrekord University of Medical Sciences
Street address
Shahrekord-kashani Blvd-University Headquarters-second floor
City
Shahrekord
Postal code
8815713471
Approval date
2017-04-23, 1396/02/03
Ethics committee reference number
IR.SKums.REC.1396.53

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
Spiritual Well-Being
Timepoint
Baseline; Imediately After; 2 months After
Method of measurement
Spiritual Well-Being Scale

2

Description
Sleep Quality
Timepoint
Baseline; Imediately After; 2 months After
Method of measurement
Pitsburgh Sleep Quality Index

3

Description
pain
Timepoint
Baseline; Imediately After; 2 months After
Method of measurement
Visual Analogue scale

Secondary outcomes

1

Description
Quality of life
Timepoint
6months After intervention
Method of measurement
SF-36 Standard Questionnaire

Intervention groups

1

Description
after obtaining the consent from from trial group, fordyce happiness program carried out in 8 sessions of 60 minutes once a week and happy principle taught with 14 element. Specified goals and tasks for each session and requested feedback from the people
Category
Behavior

2

Description
In the control group during the routine activities are follow-up and after the collection of questionnaires in in both groups, fordyce happiness program was taught in two sessions in the control group.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
chaharmahal and Bakhtiari Multiple Sclerosis Society
Full name of responsible person
kobra zaheri
Street address
Number304,Third floor,Mesbah building 3,North Ferdowsi Avenue,shahrekord
City
shahrekord

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Sponsor 1 Vice chancellor for research of Shahrekord University of Medical Sciences
Full name of responsible person
kobra zaheri
Street address
Shahrekord-Kashani Blvd-University Headquarters-second floor
City
Shahrekord
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sponsor 1 Vice chancellor for research of Shahrekord University of Medical 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
Shahrekord University of Medical Sciences
Full name of responsible person
kobra zaheri
Position
Nursing Master Student
Other areas of specialty/work
Street address
Nursing And Midwifery School, Shahrekord University of Medical Sciences, Rahmatieh, Shahrekord
City
shahrekord
Postal code
Phone
+98 33389760
Fax
Email
kobrazaheri1988@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Dr.Reza Masoudi
Position
Assisstant Professor of Shahrekord University of Medical Sciences/Ph.D in Nursing Education
Other areas of specialty/work
Street address
Nursing And Midwifery School, Shahrekord University of Medical Sciences, Rahmatieh, Shahrekord Shahrekord
City
shahrekord
Postal code
Phone
+98 38 3333 5652
Fax
Email
masoodi1383@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
kobrazaheri
Position
Nursing Master Student
Other areas of specialty/work
Street address
Nursing And Midwifery School, Shahrekord University of Medical Sciences, Rahmatieh, Shahrekord
City
shahrekord
Postal code
Phone
Fax
Email
kobrazaheri1988@gmail.com
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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