The aim of this study was to determine the effectiveness of cognitive-behavioral counseling on self-efficacy in pregnant women with chronic hypertension.
Design
A clinical trial with a control group with parallel, single-blind, randomized groups on 100 patients. A random block of even and odd numbers was used for possession.
Settings and conduct
The study population included all pregnant women with chronic hypertension who referred to health centers, gynecologists' offices and hospitals in Kurdistan province. If they have the criteria to enter and sign the consent form, they will enter the intervention. The intervention sessions will be held online and individually. With the preparation of even and odd cards by the clinic colleague, the researcher and the samples will not know about the grouping.
Participants/Inclusion and exclusion criteria
Inclusion criteria include: pregnant women up to 32 weeks, single pregnancy, no history of infertility and no diagnosis of anomaly, chronic hypertension and drug treatment, minimum literacy Reading and writing, not attending relaxation and yoga classes, no severe underlying disease, no neurological problems and anxiety disorder, no symptoms of preeclampsia, no major depression (grade 12 or higher on the Edinburgh scale) and giving informed written consent to Participants. Dissatisfaction of the samples to continue participating in the study, the need to use another treatment method during the study and diagnosis of preeclampsia will be the exclusion criteria.
Intervention groups
Participants are randomly assigned to two groups of 50, including a control group and an intervention group. The control group will receive only routine care and the intervention group will receive six 90-minute sessions of cognitive-behavioral counseling (two sessions per week) online and individually, in addition to routine care.
Main outcome variables
self-efficacy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151028024753N4
Registration date:2020-11-22, 1399/09/02
Registration timing:registered_while_recruiting
Last update:2020-11-22, 1399/09/02
Update count:0
Registration date
2020-11-22, 1399/09/02
Registrant information
Name
Mitra Kolivand
Name of organization / entity
Shahroud University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 3835 9980
Email address
mitrakolivand@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-01, 1399/08/11
Expected recruitment end date
2021-09-21, 1400/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
assessment of the Effect of Cognitive Behavioral Counseling on self-efficacy in pregnant Women with chronic Hypertension in Kurdistan province
Public title
assessment of the Effect of Cognitive Behavioral Counseling on self-efficacy in pregnant Women with chronic Hypertension in Kurdistan province
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
pregnant women up to 32 weeks of gestation
singleton pregnancy
no history of infertility
no diagnosis of anomaly
with chronic hypertension and undergoing drug treatment
minimum literacy Reading and writing
not attending relaxation and yoga classes
no severe underlying disease
no neurological problems and anxiety disorder
no symptoms of preeclampsia
no major depression
giving informed written consent to Admission
Exclusion criteria:
Dissatisfaction of the samples to continue participating in the study
diagnosis of preeclampsia
the need to use another treatment method during the study
Age
From 15 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
Investigator
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, samples will be easily or accessible and then randomly assigned to the intervention and control groups. To perform random allocation, the "random block" method, which consists of a large block for the entire sample volume, will be used. Thus, after determining the sample size by the researcher, in the first stage, this specified number will be selected from among the people who meet the inclusion criteria and have signed the informed consent form, if desired. In the next step, we assign a number from one to 100 to each of these selected people to participate in the study. In the next step, by one of the softwares, we determine 100 random numbers without repetition between one to 100, so that each of these numbers corresponds to the number assigned to each of the people that we have specified in the initial list of 100 selected. We will consider even numbers for the control group and odd numbers for the intervention group. This will not be obvious to the participants before random allocation is performed, and random sequencing will be performed by a separate individual from the other researchers.
Blinding (investigator's opinion)
Single blinded
Blinding description
The researcher and participants are unaware of their place in the intervention or control group. Samples will be placed in the intervention or control group by selecting random blocks as even or odd numbers that the researcher is unaware of
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
Kermanshah University of Medical Sciences, Eisar Square, Kermanshah, IRAN Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6714673159
Approval date
2020-05-11, 1399/02/22
Ethics committee reference number
IR.KUMS.REC.1399.145
Health conditions studied
1
Description of health condition studied
Chronic Hypertension
ICD-10 code
O10-O11, O
ICD-10 code description
Hypertensive disease complicating pregnancy, childbirth and the puerperium
Primary outcomes
1
Description
Self-efficacy
Timepoint
The beginning of the study, immediately and one month after intervention
Method of measurement
Self-efficacy questionnaire in patients with hypertension
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 6 sessions of cognitive-behavioral counseling ... Cognitive-behavioral counseling is an approach in which more correct thoughts replace dysfunctional thoughts and will change behavioral consequences ... The duration of the course is three weeks, two sessions of 90 minutes each week Will be held.
Category
Behavior
2
Description
Control group: This group will only receive routine care for high-risk pregnancies such as: controlling blood pressure, weight and symptoms of preeclampsia, listening to the fetal heartbeat, controlling danger signs such as dehydration, reduced fetal movements, pain and bleeding.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
High-risk pregnancy clinic of Besat Hospital in Sanandaj
Full name of responsible person
Shamsi Zare
Street address
Vakil Street
City
Sanandaj
Province
Kurdistan
Postal code
6619956745
Phone
+98 87 3328 5910
Email
besat@muk.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Farid Najafi
Street address
Shahid Beheshti Blvd., Building No. 2, Deputy of Research and Technology
City
kermanshah
Province
Kermanshah
Postal code
6714673159
Phone
+98 83 3838 4185
Email
research_it@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
Mitra Kolivand
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Kermanshah University of Medical Sciences, Eisar Square, Kermanshah, IRAN
City
Kermanshah
Province
Kermanshah
Postal code
6714673159
Phone
+98 83 3828 2101
Email
mitrakolivand@kums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Mitra Kolivand
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Eisar Square, Kermanshah University of Medical Sciences, Kermanshah, IRAN Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6714673159
Phone
+98 83 3828 2101
Email
mitrakolivand@kums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Asrin Lotfi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Vahdat Town
City
Sanandaj
Province
Kurdistan
Postal code
6619914681
Phone
0098 87 3312393
Email
ladykurd73@gmail.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
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