Determining the effect of individual counseling on pregnancy loss grief intensity in mothers who referred to Shahid Motahari Educational Center in Urmia in 2018
Design
Clinical trial with control group with parallel nodes
Settings and conduct
Shahid Motahari Educational Therapy Center
Participants/Inclusion and exclusion criteria
Inclusion criteria: losing pregnancy in a maximum of a week; the desire to participate in the study; being literate; speaking in Persian or Azeri; living in Orumiyeh city; mother's age of 18 to 39 years old; tending pregnancy; losing pregnancy at 8 weeks of pregnancy up to 28 days after childbirth; gain score less than 23 in GHQ28; phone access.
Exclusion criteria: having mental illness and psychiatry; use of psychiatric drugs; experience a traumatic event, such as an accident or death, passed through 6 months; infertility history; the occurrence of a stressful incident during the implementation of the plan (such as the death of loved ones, separation from the spouse); getting pregnant again; abandonment of more than two-seated in counseling.
Intervention groups
A maximum six of individual counseling sessions will be held for the intervention group.The group will receive routine post-partum care or abortion care.
Main outcome variables
In the event of effective interventions to reduce the severity of mourning, frustration and difficult coping, and in general, the reduction in the severity of the loss of early and late pregnancy loss in mothers who have lost their pregnancy or earlier mothers' recovery Mothers who do not receive interventions will be advised to provide advocacy interventions in the maternity care program with the loss of pregnancy by midwifery counselors.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151004024340N13
Registration date:2018-08-14, 1397/05/23
Registration timing:registered_while_recruiting
Last update:2018-08-14, 1397/05/23
Update count:0
Registration date
2018-08-14, 1397/05/23
Registrant information
Name
Hamideh Mohaddesi
Name of organization / entity
Urmia University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 44 3275 4963
Email address
mohaddesi.h@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-06, 1397/05/15
Expected recruitment end date
2018-12-06, 1397/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of individual counseling on pregnancy loss grief intensity in mothers who referred to Shahid Motahari Educational Center in Urmia in 2018
Public title
The effect of individual counseling on pregnancy loss grief intensity in mothers
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Losing pregnancy in a maximum of a week
The desire to participate in the study
Being literate
Mastery in Persian or Azeri
Living in Orumiyeh
Mother's age of 18 to 39 years old
Wanting pregnancy
Losing pregnancy at 8 weeks of pregnancy up to 28 days after childbirth
Gain score less than 23 in GHQ-28
Phone Access
Exclusion criteria:
Having mental illness and psychiatry, according to the mother
Use of psychiatric drugs
Experience a traumatic event, such as an accident or death, passed through 6 months
Infertility history
The occurrence of a stressful incident during the implementation of the plan (such as the death of loved ones, separation from the spouse)
Getting pregnant again
Abandonment of more than two-seated in counseling
Age
From 18 years old to 39 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment by blocking method and using all possible combinations of AAABBB blocks.For each combination, a code will be allocated and 20 codes will be randomly selected.Then, with regard to the blocks corresponding to each code and the existing combinations,we will add people to the study.
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 Urmia University of Medical Sciences
Street address
Urmia University of Medical Sciences, Urjhans alley, Resalat Boulevard
City
urmia
Province
West Azarbaijan
Postal code
5714783734
Approval date
2018-03-07, 1396/12/16
Ethics committee reference number
IR.UMSU.REC.437
Health conditions studied
1
Description of health condition studied
Grief
ICD-10 code
F43.2
ICD-10 code description
Adjustment disorders
2
Description of health condition studied
Social-Family Scale Support
ICD-10 code
ICD-10 code description
3
Description of health condition studied
Stress
ICD-10 code
F43.0
ICD-10 code description
Acute stress reaction
4
Description of health condition studied
anxiety
ICD-10 code
F41.1
ICD-10 code description
Generalized anxiety disorder
5
Description of health condition studied
depression
ICD-10 code
F32
ICD-10 code description
Major depressive disorder, single episode
Primary outcomes
1
Description
pregnancy loss grief intensity
Timepoint
At the beginning of the study and 4 weeks after the last consultation session
Method of measurement
Perinatal Grief Scale
Secondary outcomes
1
Description
Social support of family
Timepoint
At the beginning of the study and 4 weeks after the last consultation session
Method of measurement
Social support scale of the family
2
Description
Stress
Timepoint
At the beginning of the study and 4 weeks after the last consultation session
Method of measurement
Dass-42 Stress, Anxiety and Depression Questionnaire
3
Description
Anxiety
Timepoint
At the beginning of the study and 4 weeks after the last consultation session
Method of measurement
Dass-42 Stress, Anxiety and Depression Questionnaire
4
Description
Depression
Timepoint
At the beginning of the study and 4 weeks after the last consultation session
Method of measurement
Dass-42 Stress, Anxiety and Depression Questionnaire
Intervention groups
1
Description
Intervention group: for this group, a maximum of 6 individual consultation sessions will be held one hour a week and a weekly meeting will be held at the Motahari Educational Center of Urmia. During the follow-up, the researcher's telephone number will be provided to the intervention team, who will contact the counselor if necessary, and the researcher will send positive messages to the mothers during the intervention period.
Category
Other
2
Description
Control group: this group will receive routine care after childbirth or abortion.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Educational - Therapy Shahid Motahari Center
Full name of responsible person
Khatereh Oladbaniadam
Street address
Motahari hospital, Kashani Street
City
Urmia
Province
West Azarbaijan
Postal code
57147
Phone
+98 44 3223 7077
Email
oladbaniadam@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Dr.Iraj Mohabbi
Street address
Urmia University of Medical Sciences, Urjhans alley, Resalat Boulevard
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3223 4897
Email
Mohebi.i@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Oroumia 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
Oroumia University of Medical Sciences
Full name of responsible person
Khatereh Oladbaniadam
Position
Master's student in midwifery counseling
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Urmia University of Medical Sciences, college of Midwifery and Nursing
City
Urmia
Province
West Azarbaijan
Postal code
5756115111
Phone
+98 44 3275 4963
Email
oladbaniadam@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Hamideh Mohaddesi
Position
Master Educated of Midwifery, Scientific Committee Member of Nursing & Midwifery Faculty, Urmia
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Urmia collage of Midwifery and Nursing, Nazlou Campus, 11 km road to Sero
City
Urmia
Province
West Azarbaijan
Postal code
5756115111
Phone
+98 44 3275 4963
Email
Mohaddesi.han@Gmil.com
Person responsible for updating data
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Khatereh Oladbaniadam
Position
Master's student in midwifery counseling
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Urmia University of Medical Sciences, college of Midwifery and Nursing
City
Urmia
Province
West Azarbaijan
Postal code
5756115111
Phone
+98 44 3275 4963
Email
oladbaniadam@gmail.com
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
Not applicable
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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Publishing research results in the form of article publishing
When the data will become available and for how long
Start the access period 6 monthsafter printing the results
To whom data/document is available
Public
Under which criteria data/document could be used
Consultation and support program in health centers