The effect of cognitive-behavioural counselling on post-abortion grief
Design
Two group clinical trial with control group, randomized, with a sample size of 84 persons per group
Settings and conduct
The cognitive-behavioural counselling group(group A) receive six 30-40 minute counselling sessions which will hold weekly in Imam Reza clinic . The sessions Contains of: The cognitive assessment, and agreement on the aim of therapy,.... ; while control group (group B) will receive routine care such as check of vital sign and bleeding . After counselling sessions finished all patients in both group will evaluate with prenatal grief scale and they will follow up 3 months later.
Participants/Inclusion and exclusion criteria
Inclusion critria:Women with positive history of spontaneous abortion or any other abortion, age over 18 years and ability to speak and understand Persian language. Exclusion criteria :Pregnancy، History of depression ,substance abuse,Mental disorder or chronic physical illness
Intervention groups
The cognitive-behavioural counselling group(group A) receive six 30-40 minute counselling sessions which will hold weekly . The sessions Contains of: The cognitive assessment, and agreement on the aim of therapy, Providing information about grief, its process and components, normalizing its emotional and behavioral consequences of grief process ("its normal to cry when one experience such a loss"), Identifying dysfunctional irrational beliefs and their emotional behavioral and physical consequences, Teaching and practicing adaptive rational thinking and functional emotional and behavioral consequences, Assist the bereaved in a search for ways to reorganize life without the deceased ; while control group (group B) will receive routine care such as check of vital sign and bleeding .
Main outcome variables
Post abortion grief
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180407039223N2
Registration date:2018-12-30, 1397/10/09
Registration timing:prospective
Last update:2018-12-30, 1397/10/09
Update count:0
Registration date
2018-12-30, 1397/10/09
Registrant information
Name
Leila Bagheri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 5225 1581
Email address
leilabagheri94@shmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-20, 1397/12/01
Expected recruitment end date
2020-09-21, 1399/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of cognitive behavioral based counselling in post abortion grief
Public title
Effect of counselling in post abortion grief
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Women with positive history of spontaneous abortion or any other abortion
Age over 18 years
Ability to speak and understand Persian language
Exclusion criteria:
History of depression
Mental disorder
Chronic physical illness
Substance abuse
Pregnancy
Having suicidal thoughts or acting on it
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:
168
Randomization (investigator's opinion)
Randomized
Randomization description
Current research has two control and counselling group and four block sampling will be used for random allocation . In this method six possible situations 1 AABB, 2ABBA ,3ABAB ,4BBAA ,5BAAB ,6BABA will exist. Participant will choose envelope which prepared by the methodologist and might be consist of any of 1-6 situations . By selecting the first envelope, the first to fourth participant will be placed in group A or B. Again, the next participant will select another envelope and it will be known who the fifth to eighth will be in the group and this procedure will continue.
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 Shahroud University of Medical Sciences
Street address
Shahroud University of Medical Sciences-Hafte Tir Square
City
Shahroud
Province
Semnan
Postal code
۳۶۱۴۷۷۳۹۵۵
Approval date
2018-10-08, 1397/07/16
Ethics committee reference number
IR.SHMU.REC.1397.139
Health conditions studied
1
Description of health condition studied
Post abortion grief
ICD-10 code
F43.29
ICD-10 code description
Adjustment disorder with other symptoms
Primary outcomes
1
Description
Post abortion grief
Timepoint
Immediately after the end of consultation sessions and three months later
Method of measurement
Prenatal grief scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group : The cognitive-behavioural counselling group receive six 30-40 minute counselling sessions which will hold weekly in Imam Reza clinic . The sessions Contains of: The cognitive assessment, and agreement on the aim of therapy, Providing information about grief, its process and components, normalizing its emotional and behavioral consequences of grief process ("its normal to cry when one experience such a loss"), Identifying dysfunctional irrational beliefs and their emotional behavioral and physical consequences, Teaching and practicing adaptive rational thinking and functional emotional and behavioral consequences, Assist the bereaved in a search for ways to reorganize life without the deceased.
Category
Prevention
2
Description
Control group: will receive routine care such as check of vital sign and bleeding.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza hospital
Full name of responsible person
Leila Bagheri
Street address
Dr.Dadman Ave , Dr.Dadman Blvd , Shahrjadid
City
Lar
Province
Fars
Postal code
7431895417
Phone
+98 71 5224 1004
Fax
Email
Leilabagheri@yahoo.com
Web page address
http://emamreza.larums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Mohammad Hasan Emamian
Street address
Shahroud University of Medical Sciences , Hafte-Tir Square
City
Shahroud
Province
Semnan
Postal code
۳۶۱۴۷-۷۳۹۴۷
Phone
+98 23 3239 5054
Fax
+98 23 3239 4852
Email
vcr@shmu.ac.ir
Web page address
http://www.shmu.ac.ir/fa
Grant name
Grant code / Reference number
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
Leila Bagheri
Position
Candidate PhD of reproductive health
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Shahroud University of Medical Sciences , Hafte Tir Square
City
Shahroud
Province
Semnan
Postal code
۳۶۱۳۷۷۳۹۵۵
Phone
+98 23 3239 5054
Fax
Email
Leilabagheri1352@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Leila Bagheri
Position
Candidate PhD of reproductive health
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Shahroud University of Medical Sciences , Hafte Tir Square
City
Shahroud
Province
Semnan
Postal code
۳۶۱۳۷۷۳۹۵۵
Phone
+98 23 3239 5054
Email
Leilabagheri1352@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Leila Bagheri
Position
Candidate PhD of reproductive health
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Shahroud University of Medical Sciences, Hafte Tir Square
City
Shahroud
Province
Semnan
Postal code
۳۶۱۳۷۷۳۹۵۵
Phone
+98 23 3239 5054
Email
Leilabagheri1352@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available