Comparison of The Effect of Midwifery Consultation With Existential Approach and routine care On Prenatal Grief in mothers with pregnancy loss: a clinical trial
The objective of this study is Comparison of The Effect of Midwifery Consultation with existential approach on prenatal grief in mothers with pregnancy loss. Fulfilment process: objective conditions and how the study is done, is explained for the selected individuals. According to blocks of four, they’re randomly divided into intervention and control groups after filling informed consent. The control group receives routine care. Intervention group participates in weekly existential consultation sessions in addition to routine care.
Inclusion criteria: presence of abortion, ectopic pregnancy, moles, stillbirth; at least junior high-school education; no depression background, psychological disorders or physical ailments; no participation in other medical programs; not receiving individual consultation or medication; informed consent to participate in the study. Exclusion criteria: elective abortion; unmarried individuals; under 18 individuals, drug abuse.
The Primary outcome is complicated grif and and the secondary outcome is depression.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017082424339N1
Registration date:2017-10-19, 1396/07/27
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-10-19, 1396/07/27
Registrant information
Name
Ali Hadinfar
Name of organization / entity
Departeman of Biostatistic, Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 56 3226 4336
Email address
hadianfara931@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research; Shahroud University of Medical Sciences
Expected recruitment start date
2016-08-13, 1395/05/23
Expected recruitment end date
2017-09-11, 1396/06/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of The Effect of Midwifery Consultation With Existential Approach and routine care On Prenatal Grief in mothers with pregnancy loss: a clinical trial
Public title
The effect of Midwifery Consultation on Prenatal Grief
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: presence of abortion, ectopic pregnancy, moles, stillbirth; at least junior high-school education; no depression background, psychological disorders or physical ailments; no participation in other medical programs; not receiving individual consultation or medication; informed consent to participate in the study. Exclusion criteria: elective abortion; unmarried individuals; under 18 individuals, drug abuse.
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Random allocation is done through block randomization with the blocks of size four. After obtaining informed consent people assigned to intervention and control groups according to determined table
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahroud University of Medical Sciences
Street address
Central building of Shahroud University of Medical Sciences, Tir Square,Shahroud
City
Shahroud
Postal code
3614773955
Approval date
2016-04-12, 1395/01/24
Ethics committee reference number
IR.SHMU.REC.1394.18
Health conditions studied
1
Description of health condition studied
Psychological support in pregnancy
ICD-10 code
O26.9
ICD-10 code description
pregnancy-related condition unspecified
Primary outcomes
1
Description
Complicated Grif
Timepoint
Before the intervention, six weeks later, three months later
Method of measurement
Standard questionnaire of prenatal grief
Secondary outcomes
1
Description
Depression
Timepoint
Before the intervention, six weeks later, three months later
Method of measurement
Standard questionnaire of Wijma Delivery Expectancy/Experience(W-DEQ)
Intervention groups
1
Description
Control group: The control group will receive routine care.
Category
Behavior
2
Description
Intervention group: The intervention group will participate in existential sessions (6sessions,45-60 minutes) as well as receiving routine care.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Mashhad Medical Sciences Hospitals
Full name of responsible person
Soheila Mirzabeigi
Street address
Central building of Shahroud University of Medical Sciences, Tir Square,Shahroud.
City
Shahroud
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research; Shahroud University of Medical Sciences
Full name of responsible person
Dr Mohammadhasan Emamian
Street address
Central building of Shahroud University of Medical Sciences, Tir Square,Shahroud.
City
Shahroud
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research; Shahroud University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Shahroud University Of Medical Sciences
Full name of responsible person
Soheila Mirzabeigi
Position
Master Of Science Student In Midwifery Counseling
Other areas of specialty/work
Street address
Central building of Shahroud University of Medical Sciences, Hafte Tir Square, Shahroud
City
Shahroud
Postal code
3614773955
Phone
+98 2732332394499
Fax
Email
Mirzabeigi.so@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahroud University Of Medical Sciences
Full name of responsible person
Giti Atashsokhan
Position
Faculty Member
Other areas of specialty/work
Street address
Central Building Of Shahroud University Of Medical Sciences, Hafte Tir Square, Shahroud
City
Shahroud
Postal code
3614773955
Phone
+98 23 3239 5054
Fax
Email
Atashsokhan@Shmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Soheila Mirzabeigi
Position
Master of science student in midwifery counseling
Other areas of specialty/work
Street address
Central building of Shahroud University of Medical Sciences, Hafte Tir Square, Shahroud
City
Shahroud
Postal code
Phone
00
Fax
Email
Mirzabeigi.so@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)