Relieving pregnancy worries to help maintain the health of mothers with a history of fetal loss.
Design
From the Block method to volume 4 to create the allocation sequence - has two groups of control and intervention - is a parallel group - is double-blind - the total sample studied for both groups is 104 people.
Settings and conduct
By referring to the mother file by inviting telephone clients, the samples are finished. In order not to contact the intervention group with the control group, when invited to the introductory session, they are asked to refrain from contacting other pregnant mothers of Amir Semnan Hospital. The load is up to 4 sessions of 60 minutes.
There are two blinds and the data collector completes the basic questionnaires for the participants before randomly assigning them. After the intervention, the questionnaires are completed by a person who is not aware of the group and the information analyst is not aware of the group of people.
Participants/Inclusion and exclusion criteria
: Age over 18-Normal pregnancy and non-high-risk pregnancy-Single-Ability to complete the questionnaire-Ability to speak Persian-History of abortion and stillbirth and infant death in previous pregnancy
Exclusion criteria: mental disorder - addiction - any crisis of death of loved ones with physical illness in the last 6 months.
Intervention groups
Group intervention between 12 to 30 weeks of gestation with a history of fetal loss - Consultation with Seligman positivity approach - Pennsylvania questionnaire for screening for mental illness - Navidpor concern questionnaire for the intervention group
Nutrition Consulting Control Group
Main outcome variables
The primary outcome is to measure the anxiety and happiness of pregnancy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211030052913N1
Registration date:2021-11-25, 1400/09/04
Registration timing:registered_while_recruiting
Last update:2021-11-25, 1400/09/04
Update count:0
Registration date
2021-11-25, 1400/09/04
Registrant information
Name
somaye ghods
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3332 8777
Email address
somayeghods@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-08, 1400/08/17
Expected recruitment end date
2022-02-20, 1400/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
effect of counseling with a positive approach on the worries of pregnant women with a history of prenatal loss
Public title
effect of positive approach on the worries
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant Women With a Gestational Age of 12 to 30 Weeks
Pregnant Mother Over 18 Years Old
Normal Pregnancy and High risk non Pregnancy
Single
History of Late Abortion- Still Birth or Infant Death In a Previous Pregnancy
Ability to Complete The Questionnaire
Ability to Speak Persian
Exclusion criteria:
The Arrival of Any Social Crisis Such As The Death Of a Loved One
Incidence Of Physical Problems and Serious Illness In The Last Six Months
Age
From 18 years old
Gender
Female
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
104
Randomization (investigator's opinion)
Randomized
Randomization description
For Randomization The Block Method With Volume 4 Was Used To Create The Allocation Sequence; With Envelopes Were Used To Hind The Sequence; Each Sequence Is Placed Inside a White Envelope and The Envelopes Are Placed Side By Side; Each Envelope Is Numbered; An Envelope Is Opened For Each Person In The Order Of Their Entry In To The Study And Is Assigned To The Desired Group.
Blinding (investigator's opinion)
Double blinded
Blinding description
Gather Information to Blind The Individual Before Assigning Individual to Groups Basic Questionnaires Are Completed For Participants; After Interference 'It Is Done By a Person Who Is Not Aware Of The Group; The Data Analyst Is Also Not From The Study Group; Participants Are Trained And Fill Out Informed Consent Forms; They Know Their Group From The Beginning.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic Committee of Shahrod University of Medical Sciences
Street address
No.1-90, Sixth Street, Abozar Blvd,semnan Town
City
semnan
Province
Semnan
Postal code
3516878457
Approval date
2021-10-30, 1400/08/08
Ethics committee reference number
IR.SHMU.REC.1400.156
Health conditions studied
1
Description of health condition studied
Investigation of Concerns In Pregnant Women With a History Of Fetal Loss
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The Primary Outcome Is To Measure The Anxiety And Happiness Of Pregnancy
Timepoint
In the intervention group, a positive counseling program will be performed during one month. At the end of one month, the mothers' concern will be measured again using a questionnaire.
Method of measurement
First, Dr. Navidpour's anxiety questionnaire and Seligman positivity questionnaire and for screening patients with mental disorders, the Pennsylvania questionnaire will be provided to mothers with inclusion criteria.
Secondary outcomes
1
Description
There Is No Secondary Variable
Timepoint
---
Method of measurement
---
Intervention groups
1
Description
Intervention group: Pregnant Women With a History of Fetal Loss-The intervention is a group and lasts from 12 to 30 weeks of pregnancy and counseling sessions once a week for four weeks for 60 to 90 minutes. For screening patients with mental disorders before random allocation, along with the Pregnancy Concern Questionnaire, the Pennsylvania Questionnaire is given so that patients with mental disorders can be isolated and only mothers with pregnancy concerns can be included in the study.
Category
N/A
2
Description
Control group: The control group will receive 4 sessions of nutrition training during pregnancy and counseling sessions will be held in groups.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Amir al momenin Hospital
Full name of responsible person
somaye ghods
Street address
No.90-1;Sixth Street; Abozar Blvd
City
Semnan
Province
Semnan
Postal code
3516878457
Phone
+98 23 3332 8777
Email
somayeghods@yahoo.com
Web page address
https://fa.irct.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Emamion Mohamad Hasan
Street address
No.90-1;Sixth Street; Abozar Blvd
City
semnan
Province
Semnan
Postal code
3516878457
Phone
+98 23 3332 8777
Email
Somayeghods@yahoo.com
Web page address
https://fa.irct.ir
Grant name
-
Grant code / Reference number
0
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahroud 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
Shahroud University of Medical Sciences
Full name of responsible person
somaye ghods
Position
Master Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
No.90-1;Sixth Street; Abozar Blvd
City
Semnan
Province
Semnan
Postal code
3516878457
Phone
+98 23 3332 8777
Email
Somayeghods@yahoo.com
Web page address
http://fa.irct.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Somaye ghods
Position
Master Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
No.90-1;Sixth Street; Abozar Blvd
City
Semnan
Province
Semnan
Postal code
3516878457
Phone
+98 23 3332 8777
Email
Somayeghods@yahoo.com
Web page address
http://fa.irct.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Somaye ghods
Position
Master Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
No.90-1;Sixth Street; Abozar Blvd
City
Semnan
Province
Semnan
Postal code
3516878457
Phone
+98 23 3332 8777
Email
Somayeghods@yahoo.com
Web page address
http://fa.irct.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Data Can Be Shared After People Are Not Identified
When the data will become available and for how long
Access Period Starts 6 Months After The Results Are Published
To whom data/document is available
All Employed and Students In Academic Institutions and Pregnant Women
Under which criteria data/document could be used
To Reduce The Anxiety Of Pregnant Women With Fetal Loss Problems To Help Them Reduce Anxiety And Get Pregnant
From where data/document is obtainable
-----
What processes are involved for a request to access data/document