Study of the effect of group counseling based on admission and commitment on mental health and post-abortion bereavement in women with spontaneous abortion
Study of the effect of group counseling based on admission and commitment on mental health and post-abortion bereavement in women with spontaneous abortion
Design
This study will be one-blinded, study population will be included all women with spontaneous abortion referring to Motazedi hospital of Kermanshah city. A total of 60 eligible women will be selected conveniently and randomly and assigned to two intervention and control groups.
Settings and conduct
This study, which will be conducted in Motazedi hospital of Kermanshah city is one- blinded. At the beginning of the study, the grief and general health after the abortion will be investigated. The grief and general health will be reassessed in both groups immediately and one month after (the intervention in intervention group), then two groups will be compared.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Wanted pregnancy; 2 months passed of spontaneous abortion; No history of infertility
Exclusion criteria: The incidence of adverse events and outcomes during the study;Use of medication during the study
Intervention groups
The intervention group, in addition to the routine care for spontaneous abortion, will receive the group counseling based on admission and commitment in 8 sessions of 90 minutes twice a week. The intervention will be done as soon as the participants be ready and within maximum one week after the abortion. The control group will receive only the routine care.
Main outcome variables
Grief after abortion; General Health
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130812014333N105
Registration date:2018-11-07, 1397/08/16
Registration timing:registered_while_recruiting
Last update:2018-11-07, 1397/08/16
Update count:0
Registration date
2018-11-07, 1397/08/16
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-02, 1397/07/10
Expected recruitment end date
2018-11-22, 1397/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the effect of group counseling based on admission and commitment on mental health and post-abortion bereavement in women with spontaneous abortion
Public title
The effect of group counseling based on admission and commitment on mental health and post-abortion bereavement in women
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of abortion based on sonography or gynecologist diagnosis;
Wanted pregnancy;
Spontaneous abortion under 20 weeks;
2 months passed from spontaneous abortion;
General health scale scoring higher than 22.
Exclusion criteria:
Using medication during the study
The incidence of unpleasant events during the study
Age
From 18 years old to 35 years old
Gender
Female
Phase
2-3
Groups that have been masked
Data analyser
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Randomly by tossing coin
Blinding (investigator's opinion)
Single blinded
Blinding description
The Statistical analyzer is blind about allocation of study groups. In this way, the analyzer does not know which data belongs to the control or intervention group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2018-08-14, 1397/05/23
Ethics committee reference number
ir.kums.rec.1397.413
Health conditions studied
1
Description of health condition studied
Bereavement
ICD-10 code
Z63.4
ICD-10 code description
Disappearance and death of family member
Primary outcomes
1
Description
Bereavement after abortion
Timepoint
Before, after and one month after the end of the study
Method of measurement
Based on prenatal grief scale (PGS)
2
Description
Mental health
Timepoint
Before, after and one month after the end of the study
Method of measurement
Base on General Health Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group, in addition to the routine care for spontaneous abortion, will receive the group counseling based on admission and commitment for 8 sessions of 90 minutes twice a week. The intervention will be done as soon as the participants be ready and within maximum one week after the abortion.
Category
Behavior
2
Description
The control group will receive only the routine care.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Motazedi Hospital
Full name of responsible person
Shahin Sotoodeh
Street address
Ferdowsi Avenue, Motazadi Hospital
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3723 2343
Email
sh_so2de@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Farid Najafi
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3836 0014
Email
fnajafi@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Shahin Sotoodeh
Position
Master's student counseling in midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Isar Square, Dolatabad Blvd, Faculty of Nursing and Midwifery
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3826 6429
Email
sh_so2de@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Sosan heydarpour
Position
Faculty Member of Kermanshah University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Isar Square, Dolatabad Blvd, Faculty of Nursing and Midwifery
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3826 6429
Email
s.heydarpour1394@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Shahin Sotoodeh
Position
Master's student counseling in midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Isar Square, Dolatabad Blvd, Faculty of Nursing and Midwifery
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3826 6429
Email
sh_so2de@yahoo.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
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
Not applicable
Title and more details about the data/document
The main outcomes of the study will be shared.
When the data will become available and for how long
3months
To whom data/document is available
If requested, results will be made available to other academic researchers
Under which criteria data/document could be used
Collected data is confidential and will not be shared with anyone else
From where data/document is obtainable
To receive the documentation, email send for update manager
What processes are involved for a request to access data/document
In a 15-day period, the documents will be sent e-mail