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The Effectiveness of Spirituality Counseling on Coping with Pregnancy and Quality of Life in First Time Pregnant Women

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History
# Registration date Revision Id
2 2020-05-15, 1399/02/26 135046
1 2018-11-06, 1397/08/15 66125
Changes made to previous revision

  • Help:

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  • General information

    60
    empty
    2018-06-10, 1397/03/20
    2018-11-11, 1397/08/20
    2018-08-25, 1397/06/03
    2019-02-22, 1397/12/03
    2018-05-29, 1397/03/08
    empty
    2018-06-21, 1397/03/31
    empty
    2018-10-01, 1397/07/09
    empty
    empty
    Hello, The Start Date of sampling has been Incorrectly Entered and The Status of The Code has been Retrospective. Please Help to Resolve the problem.
    empty
    با سلام با توجه به اینکه تاریخ شروع نمونه گیری اشتباه وارد شده و وضعیت کد رتروسپکتیو شده است.لطفا در خصوص رفع ایرادمطرح شده مساعدت فرمایید.سپاس

  • Recruitment centers

    #1
    Name of recruitment center - English: Maternal Readiness Class at Ayatollah Mousavi Hospital
    Name of recruitment center - Persian: کلاس آمادگی زایمان بیمارستان آیت الله موسوی
    Full name of responsible person - English: masome monfared kashki
    Full name of responsible person - Persian: معصومه منفرد کاشکی
    Street address - English: Gavazang, Ayatollah Mousavi Hospital
    Street address - Persian: گاوازنگ، بیمارستان آیت الله موسوی
    City - English: zanjan
    City - Persian: زنجان
    Province: Zanjan
    Country: Iran (Islamic Republic of)
    Postal code: 4515613191
    Phone: +98 24 3314 8300
    Fax:
    Email: sanammonfared@gmail.com
    Web page address:
    Name of recruitment center - English: Childbirth Preparing Class at Ayatollah Mousavi Hospital
    Name of recruitment center - Persian: کلاس آمادگی زایمان در بیمارستان آیت الله موسوی
    Full name of responsible person - English: Masome Monfared Kashki
    Full name of responsible person - Persian: معصومه منفرد کاشکی
    Street address - English: Gavazang Road, Ayatollah Mousavi Hospital
    Street address - Persian: جاده گاوازنگ، بیمارستان آیت الله موسوی
    City - English: Zanjan
    City - Persian: زنجان
    Province: Zanjan
    Country: Iran (Islamic Republic of)
    Postal code: 4515613191
    Phone: +98 24 3314 8300
    Fax:
    Email: sanammonfared@gmail.com
    Web page address:
    #2
    Name of recruitment center - English: Zanjan Imam Hussein hospital childbirth preparation class
    Name of recruitment center - Persian: کلاس آمادگی برای زایمان بیمارستان امام حسین زنجان
    Full name of responsible person - English: masome monfared kashki
    Full name of responsible person - Persian: معصومه منفرد کاشکی
    Street address - English: Imam Hussein hospital, The Beginning of the farhangh, Zanjan
    Street address - Persian: بیمارستان امام حسین، ابتدای کوی فرهنگ، زنجان
    City - English: Zanjan
    City - Persian: زنجان
    Province: Zanjan
    Country: Iran (Islamic Republic of)
    Postal code: 4515613191
    Phone:
    Fax:
    Email: sanammonfared@gmail.com
    Web page address:
    Name of recruitment center - English: Childbirth Preparing Class at Imam Hussein Hospital of Zanjan
    Name of recruitment center - Persian: کلاس آمادگی زایمان در بیمارستان امام حسین زنجان
    Full name of responsible person - English: Masome Monfared Kashki
    Full name of responsible person - Persian: معصومه منفرد کاشکی
    Street address - English: The Beginning of The Coy Farhangh, Imam Hussein Hospital, Zanjan
    Street address - Persian: بیمارستان امام حسین، ابتدای کوی فرهنگ، زنجان
    City - English: Zanjan
    City - Persian: زنجان
    Province: Zanjan
    Country: Iran (Islamic Republic of)
    Postal code: 4515613191
    Phone: +98 24 3314 8364
    Fax:
    Email: sanammonfared@gmail.com
    Web page address:

  • Sponsors / Funding sources

    #1

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Dr Alireza Shoghli
    Full name of responsible person - Persian: دکتر علیرضا شغلی
    Street address - English: Zanjan University Of Medical Sciences, Azadi Boulevard, Zanjan
    Street address - Persian: دانشگاه علوم پزشکی زنجان، بلوار آزادی، زنجان
    City - English: Zanjan
    City - Persian: زنجان
    Province: Zanjan
    Country: Iran (Islamic Republic of)
    Postal code: 4515613191
    Phone: +98 24 3314 8300
    Fax:
    Email: sanammonfared@gmail.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Dr Alireza Shoghli
    Full name of responsible person - Persian: دکتر علیرضا شغلی
    Street address - English: Azadi Blvd, Zanjan University Of Medical Sciences, Zanjan
    Street address - Persian: دانشگاه علوم پزشکی زنجان، بلوار آزادی، زنجان
    City - English: Zanjan
    City - Persian: زنجان
    Province: Zanjan
    Country: Iran (Islamic Republic of)
    Postal code: 4515613191
    Phone: +98 24 3314 8300
    Fax:
    Email: sanammonfared@gmail.com
    Web page address:

Protocol summary

Study aim
The Effectiveness of Spirituality Counseling on Coping with Pregnancy and Quality of Life in First Time Pregnant Women
Design
In A Randomized Clinical Trial With A Control Group, 60 of Eligible Pregnant Women will be Participated in The Study. The Intervention Group will be Received 8 Sessions Counseling and Control Group will be Received Routine Care . Both Groups will be Followed for Two Month. The Outcome of The Study will be Determined in Two Steps Before and Two Month After The Last Consultation.
Settings and conduct
Sampling will be Done From Three Health Centers of Zanjan City. Firstly, 60 Eligible Women will be Selected by Convenience Method and Then will be Allocated to The Intervention and Control Groups based on The Four Blocks That are Extracted by Statistical Software. We do not have Blindness in This Study.
Participants/Inclusion and exclusion criteria
Inclusion Criteria Include: Desire to Participate in The Study; Planned Pregnancy; First Time Pregnancy; Gestational Age 20-24 Weeks; Lack of History of Known Mental and Physical Illnesses; Low Risk and Uncomplicated Pregnancy; Singleton Pregnancy; Getting Score From 18 to 36 by Cohen Perceived Stress Questionnaire; Getting Score Lower Than 10 by Edinburgh Depression Inventory. Exclusion Criteria Include: Unwilling to Participate in The Study; The Absence of More Than Two Sessions
Intervention groups
The intervention group, in addition to the Pregnancy Preparation classes, will receive group counseling for the spirituality-centered and control groups only for the preparation of maternity wards.
Main outcome variables
Quality of Life and Coping with First Pregnancy

General information

Reason for update
Hello, The Start Date of sampling has been Incorrectly Entered and The Status of The Code has been Retrospective. Please Help to Resolve the problem.
Acronym
IRCT registration information
IRCT registration number: IRCT20150731023423N12
Registration date: 2018-11-06, 1397/08/15
Registration timing: prospective

Last update: 2020-05-19, 1399/02/30
Update count: 1
Registration date
2018-11-06, 1397/08/15
Registrant information
Name
Azam Maleki
Name of organization / entity
Zanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 24 3345 4264
Email address
malekia@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-11, 1397/08/20
Expected recruitment end date
2019-02-22, 1397/12/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effectiveness of Spirituality Counseling on Coping with Pregnancy and Quality of Life in First Time Pregnant Women
Public title
The Effectiveness of Spirituality Counseling on Coping with Pregnancy and Quality of Life in First Time Pregnant Women
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Desire to Participate in The Study Planned Pregnancy First Time Pregnancy Gestational Age 20-24 Weeks Lack of History of Known Mental and Physical Illnesses Low Risk and Uncomplicated Pregnancy Singleton Pregnancy Getting Score From 18 to 36 by Cohen Perceived Stress Questionnaire Getting Score Lower Than 10 by Edinburgh Depression Inventory
Exclusion criteria:
Unwilling to Participate in The Study The Absence of More Than Two Sessions consultaion
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible Women will be Selected Using The Convenience Sampling Method and They will be Randomly Allocated to The Intervention and The Control Groups using Statistical software Randomized 4-Block method.
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
Ethics Committee of Zanjan University of Medical Sciences
Street address
Azadi Blvd, Zanjan University of Medical Sciences, Zanjan
City
Zanjan
Province
Zanjan
Postal code
4515613191
Approval date
2018-05-28, 1397/03/07
Ethics committee reference number
IR.ZUMS.REC.1397.024

Health conditions studied

1

Description of health condition studied
Quality of Life, Coping With Pregnancy
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Quality of life
Timepoint
Before and Two Months After The Last Session of Consultation
Method of measurement
Quality of Life Questionnaire

Secondary outcomes

1

Description
Copy With Pregnancy
Timepoint
Before and Two Months After The Last Session of Consultation
Method of measurement
Coping With Pregnancy Questionnaire

Intervention groups

1

Description
Participants in the intervention group will receive 8 group counseling sessions based on bipartite duality and 45 minutes per session for routine nursing care. The length of a one-month period and the content of the sessions include titles of forgiveness, repentance, meditation, the effect of the Qur'an, and authority on the birth and the fetus.
Category
Prevention

2

Description
Control group: Control group: The control group is the first 30 pregnant women attending routine childbirth classes, and no intervention by the investigator is applied to this group.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Childbirth Preparing Class at Ayatollah Mousavi Hospital
Full name of responsible person
Masome Monfared Kashki
Street address
Gavazang Road, Ayatollah Mousavi Hospital
City
Zanjan
Province
Zanjan
Postal code
4515613191
Phone
+98 24 3314 8300
Fax
Email
sanammonfared@gmail.com

2

Recruitment center
Name of recruitment center
Childbirth Preparing Class at Imam Hussein Hospital of Zanjan
Full name of responsible person
Masome Monfared Kashki
Street address
The Beginning of The Coy Farhangh, Imam Hussein Hospital, Zanjan
City
Zanjan
Province
Zanjan
Postal code
4515613191
Phone
+98 24 3314 8364
Email
sanammonfared@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr Alireza Shoghli
Street address
Azadi Blvd, Zanjan University Of Medical Sciences, Zanjan
City
Zanjan
Province
Zanjan
Postal code
4515613191
Phone
+98 24 3314 8300
Email
sanammonfared@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan 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
Zanjan University of Medical Sciences
Full name of responsible person
Masome Monfared Kashki
Position
Msc Student in Midwifery Counseling
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Gavazang Road, Zanjan University Of Medical Sciences, Zanjan
City
Zanjan
Province
Zanjan
Postal code
4515613191
Phone
+98 24 3345 7707
Email
sanammonfared@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Maleki Azam
Position
PhD in Maternal & Child Health
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Gavazang Road, Zanjan University Of Medical Sciences, Zanjan
City
Zanjan
Province
Zanjan
Postal code
4515613191
Phone
+98 24334206519
Email
Makekia@zums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Maleki Azam
Position
PhD in Maternal & Child Health
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Gavazang Road, Zanjan University Of Medical Sciences, Zanjan
City
Zanjan
Province
Zanjan
Postal code
4515613191
Phone
+98 24334206519
Email
Malekia@zums.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
Dissatisfaction participants
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
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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