Determine the effect of individual counseling on the rate of participation of pregnant mothers in decision making in the treatment process.
Design
A clinical trial with a control group, based on counseling, with parallel groups, randomized.
Settings and conduct
The study population consisted of all pregnant women referring to the Qazvin Qazvin Medical and Therapeutic Centers who have entered the study.
At first, 190 patients were randomly selected and randomly assigned randomization method was used to select pregnant women. In this way, the affected women are divided into two intervention groups (the counseling group) and the control group (the group that does not receive counseling).
Participants/Inclusion and exclusion criteria
Entry criteria include:
1- Pregnant women with a pregnancy of 10 to 36 weeks
2-Inclination to participate in research
3. No history of psychiatric disorders (self-reported).
Exclusion criteria include:
1. Pregnant mothers need emergency measures
2- Pregnant women complained of labor pain
3- Pregnant mothers who are not at all alert.
Intervention groups
Pregnant women are divided into two intervention groups (the counseling group) and the control group (the group that does not receive counseling).
Main outcome variables
Comparison of participation rate in decision making of pregnant women in intervention and control group before intervention
Comparison of participation rate in decision making of pregnant mothers in intervention and control group after intervention
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180508039583N1
Registration date:2018-06-02, 1397/03/12
Registration timing:prospective
Last update:2018-06-02, 1397/03/12
Update count:0
Registration date
2018-06-02, 1397/03/12
Registrant information
Name
Rashin Nasiri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3365 3373
Email address
r.nasiri@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-22, 1397/04/01
Expected recruitment end date
2018-12-22, 1397/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of individual counseling on the rate of maternal involvement in decision making in the treatment process.
Public title
The effect of counseling on decision making in the treatment process.
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant mothers with a pregnancy of 10 to 36 weeks
Inclination to participate in research
Not having a history of psychiatric disorders (self-reported)
Exclusion criteria:
Pregnant mothers need emergency measures
Pregnant mothers complained of labor pain
Pregnant mothers who are not alert
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
190
Randomization (investigator's opinion)
Randomized
Randomization description
The random allocation method is used to determine the intervention and control groups.This means that for the two groups, the names A and B are considered.The letters to the number of participants will be written on paper pieces of a shape and shape, and through the lottery, the people will remove the people without replacing the paper, then the generated sequence will be recorded.In this way, pregnant women in the study are divided into two groups of 95-member intervention (the group receiving counseling) and a control group of 95 people (the group who does not receive counseling).
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 on Research Qazvin University of Medical Sciences
Street address
Shahid Bahonar Blvd.
City
Qazvin
Province
Qazvin
Postal code
3419759811
Approval date
2018-05-19, 1397/02/29
Ethics committee reference number
IR.QUMS.REC.1397.042
Health conditions studied
1
Description of health condition studied
Investigating the impact of individual counseling on participation rates
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The score of participation of pregnant mothers in the questionnaire of share Decision making
Timepoint
Measuring the rate of participation of pregnant mothers before the intervention begins, immediately after the intervention
Method of measurement
Share decision making questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Pregnant mothers 10 to 36 weeks that get consultant.
Category
N/A
2
Description
Control group: Pregnant mothers 10 to 36 weeks that don't get consultant But they will attend a counseling session on pregnancy nutrition (placebo)
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinic of Kowsar Medical Center of Qazvin
Full name of responsible person
Mahboubeh Garshasbi
Street address
Kowsar Hospital, next to the Power Department, Vali Asr Ave.
City
Qazvin
Province
Qazvin
Postal code
34156-13176
Phone
+98 28 3323 6374
Email
hoskosar@qums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
معاونت پژوهشی دانشگاه علوم پزشکی قزوین
Full name of responsible person
Mohammad Ali Soleimani
Street address
Faculty of Nursing and Midwifery ،University of Medical Sciences, Shahid Bahonar Boulevard، Qazvin
City
Qazvin
Province
Qazvin
Postal code
3419759811
Phone
+98 28 3333 8034
Email
nursingpublicaffairs@qums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
معاونت پژوهشی دانشگاه علوم پزشکی قزوین
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
Qazvin University of Medical Sciences
Full name of responsible person
Rashin Nasiri
Position
Master's student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Kowsar Hospital, next to the Power Department, Valiasr St., Qazvin