Protocol summary

Summary
The aim of This randomized clinical trial study is: The Effect of spiritual Counseling base on spiritual intelligence on Anxiety, stress and depression of pregnant Women. Inclusion criteria include of Willingness to participate in the research, single and live fetus, being in the third trimester, lack of physical illness or a history of high-risk pregnancy , Lack of experience of depression and anxiety disorders in first degree relatives, And Lack of history of depression and anxiety and Antidepressants and anti-anxiety drugs in pregnancy or before, Health hearing , Having depression score 10 (mild depression upward), at least 8 of anxiety (anxiety, mild upward) and a minimum score of 15 stress (stress slightly upward), using questionnaire of depression, anxiety and stress . Exclusion criteria include of lack of cooperation, pregnancy complications or problems that prevent a person to attend classes. At this study 66 pregnant women that refered to Fatemieh Hospital, Hamedan (2015), which were randomly assigned into two groups. The experimental group received 8 sessions of spiritual counseling and the control group took routine prenatal care. Then we will evaluat effect of spiritual counseling on depression, anxiety and stress of volunteers, using a anxiety, stress and depression questionnaire

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013121515341N3
Registration date: 2015-05-15, 1394/02/25
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-05-15, 1394/02/25
Registrant information
Name
Batul Khodakarami
Name of organization / entity
Hamedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0447
Email address
khodakaramy@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Hamadan university of medical sciences
Expected recruitment start date
2015-03-03, 1393/12/12
Expected recruitment end date
2015-06-02, 1394/03/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of spiritual Counseling base on spiritual intelligence on depression, Anxiety and stress of pregnant Women
Public title
the effect of Spirituality on depression, anxiety and stress
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Willingness to participate in the research , single and live fetus, being in the third trimester, lack of physical illness or a history of high-risk pregnancy , Lack of experience of depression and anxiety disorders in first degree relatives, And Lack of history of depression and anxiety and Antidepressants and anti-anxiety drugs in pregnancy or before, Having depression score 10 (mild depression upward), at least 8 of anxiety (anxiety, mild upward) and a minimum score of 15 stress (stress slightly upward), using questionnaire of depression, anxiety and stress. Exclusion criteria: lack of cooperation, pregnancy complications or problems that prevent a person to attend classes
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 66
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
Vice Chancellor for Research and Technology of Hamadan University of Medical Sciences
Street address
Hamedan University of Medical Sciences and Health Services, St.Shahid Fahmide ,Hamedan
City
Hamedan
Postal code
65178
Approval date
2015-03-02, 1393/12/11
Ethics committee reference number
6384/9/35/16/پ

Health conditions studied

1

Description of health condition studied
Depression, anxiety and stress in pregnancy
ICD-10 code
F41.2
ICD-10 code description
Mixed anxiety and depressive disorder

Primary outcomes

1

Description
Depression
Timepoint
Before intervention, two months after the intervention
Method of measurement
Questionnaire of depression, anxiety and stress (dass)

2

Description
anxiety
Timepoint
Before intervention, two months after the intervention
Method of measurement
Questionnaire of depression, anxiety and stress (dass)

3

Description
stress
Timepoint
Before intervention, two months after the intervention
Method of measurement
Questionnaire of depression, anxiety and stress (dass)

Secondary outcomes

1

Description
Spiritual Intelligence
Timepoint
Before intervention, Two months after the intervention
Method of measurement
Questionnaire of Spiritual Intelligence King

Intervention groups

1

Description
Intervention group: providing spiritual counseling base on spiritual intelligence component to pregnant women by midwives and psychologist with group counseling approach. Counseling sessions 8 .sessions of 45 minutes for groups of pregnant women is 8 members.
Category
Treatment - Other

2

Description
Control group: training and regular prenatal care
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Fatemieh Hospital of Hamadan
Full name of responsible person
Faegheh Golalizadeh
Street address
Fatemieh Hospital, St:Sepah, Hamedan
City
Hamedan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hamedan University of Medical sciences
Full name of responsible person
Saeed Bashirian
Street address
Vice Chancellor for Research & Technology, Hamedan University of Medical Sciences, St.Shahid Fahmide, Hamedan
City
Hamedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Faegheh GolAlizadeh
Position
MSc Student in Midwifery counseling
Other areas of specialty/work
Street address
Hamedan University of Medical Sciences, St:Shahid Fahmide, Hamedan
City
Hamedan
Postal code
65178
Phone
+98 81 3838 0150
Fax
Email
golalizadeh2010@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Batul Khodakarami
Position
Master of Science, Faculty of Nursing and Midwifery
Other areas of specialty/work
Street address
Hamedan University of Medical Sciences, St:Shahid Fahmide, Hamedan
City
Hamedan
Postal code
65178
Phone
+98 81 3838 0150
Fax
+98 38380447
Email
khodakaramy@umsha.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Batul Khodakarami
Position
Master of Science, Faculty of Nursing and Midwifery
Other areas of specialty/work
Street address
Hamedan University of Medical Sciences, St:Shahid Fahmide, Hamedan
City
Hamedan
Postal code
65178
Phone
+98 81 3838 0150
Fax
Email
khodakaramy@umsha.ac.ir
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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