To assess the effect of counseling with spouses versus control group on the resilience of women with high-risk pregnancy
Design
This is a Phase III randomized clinical trial with a control group with parallel groups without blinding, in which 118 eligible patients will be randomly assigned to the intervention and control groups using block randomization.
Settings and conduct
This is a Phase III randomized clinical trial with a control group with parallel groups without blinding that will be conducted at the Fatemieh Hospital in Hamadan city, involving 118 eligible women with high-risk pregnancy. The patients will be randomly assigned to the intervention and control groups through the block randomization. However, it should be noted that blinding is not feasible in this trial.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age 18 to 35 years;
Gestation age 24 to 32 weeks;
Obtaining a score less than 50 from the CD-RISC-25 resilience questionnaire;
Iranian nationality;
Being literate;
Ability to speak Farsi;
Living with a spouse;
Exclusion criteria:
Mental disorders and depression;
Intrauterine death of the fetus;
Childbirth at the time of the study
Intervention groups
Intervention group:
Routine prenatal care plus weekly counseling sessions for a maximum of one and a half hours for four weeks
Control group:
Only routine prenatal care
Main outcome variables
The average resilience score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N515
Registration date:2024-06-16, 1403/03/27
Registration timing:prospective
Last update:2024-06-16, 1403/03/27
Update count:0
Registration date
2024-06-16, 1403/03/27
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-07-05, 1403/04/15
Expected recruitment end date
2024-10-06, 1403/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of counseling with spouses versus control group on the resilience of women with high-risk pregnancy: a randomized clinical trial
Public title
Effect of counseling with spouses versus control group on the resilience of women with high-risk pregnancy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 to 35 years
Gestation age 24 to 32 weeks
Obtaining a score less than 50 from the CD-RISC-25 resilience questionnaire
Iranian nationality
Being literate
Ability to speak Farsi
Living with a spouse
Exclusion criteria:
Mental disorders and depression
Intrauterine death of the fetus
Childbirth at the time of the study
Age
From 18 years old to 35 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
118
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, random assignment of patients to the intervention and control groups will be carried out using block randomization. To achieve this, four sheets of paper will be prepared - two with the name of the intervention and two with the name of the control. These paper sheets will be pooled and placed in a container. Patients will be selected one at a time without replacement, and for each patient, a paper sheet will be randomly drawn from the container. After each draw, the paper sheets will be returned to the container, and the process will be repeated until the desired sample size is reached.
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 Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2024-05-11, 1403/02/22
Ethics committee reference number
IR.UMSHA.REC.1403.106
Health conditions studied
1
Description of health condition studied
high-risk pregnancy
ICD-10 code
O09
ICD-10 code description
Supervision of high risk pregnancy
Primary outcomes
1
Description
The average resilience score
Timepoint
Before the intervention and one month after
Method of measurement
Using the Connor and Davidson resilience scale (CD-RISC-25)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Routine prenatal care plus weekly counseling sessions for a maximum of one and a half hours for four weeks (including familiarization with physical problems associated with high-risk pregnancy; clinical aspects of high-risk pregnancy; physical and mental needs of pregnant women and the importance of adapting to high-risk pregnancy; avoiding feelings and thoughts caused by wrong knowledge; the effect of companionship on pregnancy outcomes and mental health of pregnant women; the effect of companionship on pregnancy outcomes and mental health of pregnant women; comparison of the outcome of high-risk pregnancy with and without spousal support; increasing communication skills, especially the verbal expression of feelings and interest; introducing supportive behaviors of spouses during pregnancy; Husband’s availability and timely presence at home if needed; assisting in household chores such as cooking and cleaning and doing household shopping
Category
Treatment - Other
2
Description
Control group: Only routine prenatal care
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemieh Hospital in Hamadan city
Full name of responsible person
Azin Latifi
Street address
Fatemieh Hospital, Pasdaran Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3828 3939
Email
azinlatifi77@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Reza Shokoohi
Street address
Hamadan University of Medical Sciences, Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Azin Latifi
Position
Midwifery Student
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
azinlatifi77@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Farzaneh Soltani
Position
Reproductive Health Specialist
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
farzanehsoltani2008@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.ac.ir
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
Undecided - It is not yet known if there will be a plan to make this available
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
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available