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The Effec of Consultation Using Positive Approach on Maternal Adaptation and Severity of Pregnancy of Nausea and Vomiting

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History
# Registration date Revision Id
2 2020-10-31, 1399/08/10 157181
1 2020-10-31, 1399/08/10 156810
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  • General information

    2020-10-26, 1399/08/05
    2020-11-01, 1399/08/11
    empty
    Changing the start time of sampling
    empty
    تغییرشروع زمان نمونه گیری

  • Recruitment centers

    #1
    Name of recruitment center - English: Zanjan Health Centers
    Name of recruitment center - Persian: مراکز بهداشتی شهر زنجان
    Full name of responsible person - English: Mina Abbasi
    Full name of responsible person - Persian: مینا عباسی
    Street address - English: Health centers
    Street address - Persian: مراکز بهداشتی
    City - English: Zanjan
    City - Persian: زنجان
    Province: Zanjan
    Country: Iran (Islamic Republic of)
    Postal code: 45156131910
    Phone: +98 24 1433 8300
    Fax:
    Email: mina.abbac@yahoo.com
    Web page address:
    Name of recruitment center - English: Zanjan Health Centers
    Name of recruitment center - Persian: مراکز بهداشتی شهر زنجان
    Full name of responsible person - English: Mina Abbasi
    Full name of responsible person - Persian: مینا عباسی
    Street address - English: All of Zanjan Health Centers
    Street address - Persian: ;کلیه مراکز بهداشتی درمانی شهر زنجان
    City - English: Zanjan
    City - Persian: زنجان
    Province: Zanjan
    Country: Iran (Islamic Republic of)
    Postal code: 45156131910
    Phone: +98 24 1433 8300
    Fax:
    Email: mina.abbac@yahoo.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: Health centers
    Street address - Persian: مراکز بهداشتی
    City - English: Zanjan
    City - Persian: زنجان
    Province: Zanjan
    Country: Iran (Islamic Republic of)
    Postal code: 4515613191
    Phone: +98 24 1433 8300
    Fax:
    Email: mina.abbac@yahoo.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: Second Building, First Floor, Vice Chancellor for Research and Technology, Zanjan University of Medical Sciences, Azadi Blvd.Zanjan,Iran
    Street address - Persian: ایران، زنجان، بلوار آزادی، دانشگاه علوم پزشکی زنجان، ساختمان دوم، طبقه اول، معاونت تحقیقات و فناوری
    City - English: Zanjan
    City - Persian: زنجان
    Province: Zanjan
    Country: Iran (Islamic Republic of)
    Postal code: 4515613191
    Phone: +98 24 1433 8300
    Fax:
    Email: mina.abbac@yahoo.com
    Web page address:

Protocol summary

Study aim
The Effect of Counseling Using Positive Approach on Maternal Adaptation and Severity of Pregnancy Nausea and Vomiting
Design
The Present Study Is Phase 3 Of A Randomized Clinical Trial, Has A Control Group With Parallel Groups. That Will Be Performed On 60 Patients (30 Interventions And 30 Control Interventions). We Do Not Have Blinding. Eligible Women Will Be Selected By Convenience Sampling Method And Will Be Assigned To Two Intervention And Control Groups Using 4 Random Blocks.
Settings and conduct
The Study Population Includes Women with Nausea and Vomiting That Will be Selected Using the convenience Sampling Method and then Randomly Assigned to the Intervention and Control Groups by the 4 Block Design.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Having 3-16 Scores Based on the Reduz Pregnancy Nausea and Vomiting Questionnaire, Gestational Age 6-10 Weeks, Age 18-35 Years, Wanted Pregnancy, Normal Pregnancy and Access to Telephone. Exclusion criteria: Having High-Risk Pregnancy Symptoms, Stressful Events, Unwillingness to Continue Participating in The Study.
Intervention groups
The Intervention Group Six Sessions of Individual Positive Counseling Based on The Silgman Protocol (2006) Will be Done With Emphasizing the three Paths to Happiness (Enjoyment, Commitment, and Meaning in Life). Each Session Will be Done 45 Minutes in 3 Times a Week. The Control Group will Receive Routine Care.
Main outcome variables
Coping and Severity of Nausea and Vomiting in Pregnancy

General information

Reason for update
Changing the start time of sampling
Acronym
IRCT registration information
IRCT registration number: IRCT20150731023423N17
Registration date: 2020-10-31, 1399/08/10
Registration timing: prospective

Last update: 2020-11-02, 1399/08/12
Update count: 1
Registration date
2020-10-31, 1399/08/10
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
2020-11-01, 1399/08/11
Expected recruitment end date
2021-02-23, 1399/12/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effec of Consultation Using Positive Approach on Maternal Adaptation and Severity of Pregnancy of Nausea and Vomiting
Public title
"The Effec of Consultation Using Positive Approach on Maternal Adaptation and Severity of Pregnancy of Nausea and Vomiting"
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having 3-16 Scores Based on RHODES' Pregnancy Nausea and Vomiting Questionnaire Gestational Age 6-10 Weeks Wanted Pregnancy Phone Access Normal Pregnancy The Lack of Chronic Disease The lack of Psychological disease
Exclusion criteria:
Having of High-risk Pregnancy Symptoms Occurrence of Severe Stressful Events Such as Divorce or Death of Loved Ones Not Desire to Continue to Participate in The Study More Than Two Absence in Counseling Sessions
Age
From 18 years old to 35 years old
Gender
Female
Phase
3
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. According to the Sample Size, They Will be Randomly Allocated to the Intervention and Control Groups Using Randomized 4-Block by Table of Random Number.The Sequence of Blocks Will be Placed on a Separate Sheet Inside the Matte Envelope. In the Present Study, We do not Have Blinding.
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
Second building, first floor, Deputy of Research and Technology,,Zanjan University of Medical Sciences, Azadi Blvd, Zanjan, Iran
City
Zanjan
Province
Zanjan
Postal code
۴۵۱۵۶۱۳۱۹۱
Approval date
2020-01-14, 1398/10/24
Ethics committee reference number
IR.ZUMS.REC.1398.436

Health conditions studied

1

Description of health condition studied
Pregnancy Nausea and Vomiting
ICD-10 code
O21.0
ICD-10 code description
Mild hyperemesis gravidarum

Primary outcomes

1

Description
Severity of Pregnancy Nausea and Vomiting
Timepoint
Before Intervention, Daily up to two Weeks, Immediately After Intervention, and Four Weeks After Intervention
Method of measurement
RHODES' Nausea and Vomiting Severity Questionnaire

2

Description
Coping With Pregnancy
Timepoint
Before Intervention, Immediately After Intervention, and Four Weeks After Intervention
Method of measurement
Coping With Pregnancy Questionnaire NuPCI

Secondary outcomes

1

Description
Severity of Nausea and Vomiting
Timepoint
Before Intervention, The End of The Intervention and 4 Weeks After The Intervention
Method of measurement
Reduz Nausea and Vomiting questionnaire

2

Description
coping with pregnancy
Timepoint
Before Intervention, and 4 weeks after Intervention
Method of measurement
Hamilton coping with pregnancy

Intervention groups

1

Description
Intervention Group, 6 Sessions Positive Counseling Based on The Protocol of Sligman et al. (2006) will be Received Individually From The 6th Week of Gestation. Each Session will be Done 45 Minutes in Three Times a Week.The Content of The Sessions Includes The Introduction of Three Paths to Happiness (Enjoyment, Commitment, and Meaning in Life) in The Form of a Practice of Forgiveness in Life, a Discussion of Meaning in Life and Its Role in Reducing Negative Emotions, Optimism, Life Satisfaction, Enjoying The Moments and Situations That They Have, Practicing Personal Heritage Skills, Training Subjects to Control Emotions, Acquainting People With Positive Emotions and Its Role in Reducing Pregnancy-related Stressors, Familiarity With One's Abilities and The Role of Support From Other Family Members and Spouse in Adapting to Pregnancy, Reviewing People's Attitudes Towards Commitment and Responsibility in Life and Pregnancy, Practicing The Art of Appreciation in Life, Practicing Thanksgiving in Life, Practicing The Skill of Remembering Three Blessings a Day, Learning to Improve Positive Social Relationships, Constructive Active Response Techniques Will be Discussed.The Control Group Will be Received Only Routine Care, Which Includes Lifestyle Modification to Control Nausea and Vomiting During Pregnancy According to The Protocol of The Ministry of Health,
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Zanjan Health Centers
Full name of responsible person
Mina Abbasi
Street address
All of Zanjan Health Centers
City
Zanjan
Province
Zanjan
Postal code
45156131910
Phone
+98 24 1433 8300
Email
mina.abbac@yahoo.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
Second Building, First Floor, Vice Chancellor for Research and Technology, Zanjan University of Medical Sciences, Azadi Blvd.Zanjan,Iran
City
Zanjan
Province
Zanjan
Postal code
4515613191
Phone
+98 24 1433 8300
Email
mina.abbac@yahoo.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
Mina Abbasi
Position
Master Student of Counseling In Midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
School of nursing and midwifery ,Zanjan University of Medical Sciences, Gavazang Road, Zanjan, Iran
City
Zanjan
Province
Zanjan
Postal code
4515613191
Phone
+98 24 3234 5031
Email
mina.abbac@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Azam Maleki
Position
PhD in Maternal And Child Health
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Second Building, First Floor, Social Determinants of Health"Research Center "Vice Chancellor for Research and TechnologyIran, Zanjan University of Medical Sciences,Azadi Blvd, Zanjan,Iran
City
Zanjan
Province
Zanjan
Postal code
4515613191
Phone
+98 24 3342 0651
Email
Malekia@zums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Azam Maleki
Position
PhD in Maternal And Child Health
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Second Building, First Floor, Social Determinants of Health"Research Center "Vice Chancellor for Research and TechnologyIran, Zanjan University of Medical Sciences, Azadi Blvd, Zanjan,Iran
City
Zanjan
Province
Zanjan
Postal code
4515613191
Phone
+98 24 3342 0651
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
Possibility of Dissatisfaction of 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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