Determining the effect of hope therapy on psychological well-being in mothers after abortion
Design
Randomized controlled trial with two parallel arms
Settings and conduct
This study will be performed in Al-Zahra and Taleghani educational and therapeutic centers in Tabriz on 52 women aged 15 to 49 whose pregnancy has led to abortion. In the study, informed written consent will be obtained and initial evaluations will be performed. Participants will be assigned to the intervention and control groups using a block randomization method with block sizes of 4 and 6 and with a 1:1 allocation ratio.
Participants/Inclusion and exclusion criteria
inclusion criteria: Women with loss of pregnancy less than 20 weeks of pregnancy, Minimum secondary education and living in Tabriz
exclusion criteria: Suffering from mental illnesses and taking any psychological medication, having a history of chronic physical diseases and experiencing a severe psychological crisis during the last 3 months, such as the death of relatives
Intervention groups
For the intervention group, group counseling with hope therapy approach will be held in 8 sessions of 45 minutes, twice a week.
The control group will receive routine post-abortion care.
Main outcome variables
Mean score of psychological well-being
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120718010324N60
Registration date:2020-12-17, 1399/09/27
Registration timing:registered_while_recruiting
Last update:2020-12-17, 1399/09/27
Update count:0
Registration date
2020-12-17, 1399/09/27
Registrant information
Name
Mojgan Mirghafourvand
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1479 6969
Email address
mirghafourvandm@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-09, 1399/09/19
Expected recruitment end date
2021-03-19, 1399/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of hope therapy counseling on psychological well-being of mothers after abortion: a randomized controlled trial
Public title
The effect of hope therapy on psychological well-being of mothers after abortion
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 15 to 49 years
Not participation in similar studies
Loss of pregnancy less than 20 weeks of pregnancy
Having at least secondary education
Living in Tabriz
Having a phone number
Non-addiction to drugs, alcohol and cigarettes according to the self-report
Exclusion criteria:
Suffering from mental illnesses and taking any psychological medication according to the person's own statement
Having a history of chronic physical diseases (diabetes, heart disease, high blood pressure, cancer, kidney disease, lung disease, iron deficiency anemia, thyroid diseases and epilepsy) according to her statement
Experiencing a severe psychological crisis during the last 3 months, such as the death of relatives, according to her statement
Age
From 15 years old to 49 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
52
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be assigned to the intervention (counseling) and control groups using stratified random blocking method (Stratification based on abortion history and type of abortion (spontaneous or induced)) with the block sizes of 4 and 6 and with a 1: 1 allocation ratio. The allocation sequence will be determined by a person not involved in the study using Randomizer software. In order to hide the allocation (Allocation Concealment), the type of intervention is written on paper and sealed in opaque envelopes. The envelopes will be opened in order of the participants entering the study and the type of group will be determined.
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 Tabriz University of Medical Sciences
Street address
Faculty of Nursing Midwifery, South Shariati Street
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Approval date
2020-11-25, 1399/09/05
Ethics committee reference number
IR.TBZMED.REC.1399.815
Health conditions studied
1
Description of health condition studied
Psychological well being after abortion
ICD-10 code
Z00.4
ICD-10 code description
General psychiatric examination, not elsewhere classified
Primary outcomes
1
Description
Psychological well-being
Timepoint
Before, right after and four weeks after the intervention
Method of measurement
Psychological Well-being Questionnaire
Secondary outcomes
1
Description
Quality of Life
Timepoint
Before, right after and four weeks after the intervention
Method of measurement
WHO Quality of Life (WHOQOL) Standard Questionnaire
Intervention groups
1
Description
Intervention group: In this study, counseling will be provided with each of the participants in the intervention group through hope therapy approach in 8 sessions of 45 minutes twice a week in native language. Hope therapy is done in 2 main stages, each of which consists of 2 steps. The first stage is hope-building, which includes recognizing hope by telling your story and consolidating hope. In the next stage, hope-rising includes increasing hope through goal-improvement techniques, creating a framework for revealing goals, creating clear and practical goals, management of obstacles placed on the path of hope and finally the retention of hope.
Category
Other
2
Description
The control group will receive routine post-abortion care.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Educational and Medical Centers
Full name of responsible person
Fatemeh Rafi
Street address
Alzahra Educational and Treatment Center, South Artesh street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
۵۱۳۸۶۶۵۷۹۳
Phone
+98 41 3553 9163
Email
fatemeh.rafi.2017@gmail.com
2
Recruitment center
Name of recruitment center
Taleghani Educational and Medical Centers
Full name of responsible person
Fatemeh Rafi
Street address
Talegani hospital, Rah Ahan square, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5197615413
Phone
+98 41 3442 4425
Email
fatemeh.rafi.2017@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Samiei
Street address
Research department, third floor, central construction number 2, Tabriz medical science university, Golgasht Street, Azadi Avenue, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 6770
Email
mirghafourvandm@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Fatemeh Rafi
Position
MSc student of counseling in midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing & Midwifery, South Shariati Street
City
Tabriz
Province
East Azarbaijan
Postal code
5183915471
Phone
+98 41 3440 0153
Email
fatemeh.rafi.2017@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mojgan Mirghafourvand
Position
PhD of Reproductive Health
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing & Midwifery, South Shariati Street
City
Tabriz
Province
East Azarbaijan
Postal code
9876598765
Phone
+98 56 7654 3890
Email
mirghafouurvandm@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mojgan Mirghafourvand
Position
PhD of Reproductive Health
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing & Midwifery, South Shariati Street
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3452 6493
Email
mirghafourvandm@tbzmed.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Participant data is confidential
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
No - There is not 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