Determination of the effect of group counseling based on motivational interviewing approach on self-efficacy, anxiety, and fear of childbirth, in pregnant women
Design
Randomized controlled clinical trial with two parallel arms
Settings and conduct
This study will be conducted on pregnant women referring to obstetric clinic of Yahyanejad Hospital of Babol city. The researchers will invite the pregnant women with gestational age of 26 to 33 weeks to participate in the study. Participants with who have conditions for entry the study, allocate randomly into two groups. The participants of group A (35 persons) will be receive combination of standard medical care of prenatal care and group motivational interviewing for 5 weeks. The participants of group B (35 persons) receive only standard medical care of prenatal care. All participants will be filled four questionnaires including; Childbirth Self-efficacy Inventory (CBSI), Revised Prenatal Distress Questionnaire (NUPDQ), State-Anxiety of Spielberge (STAI)
Expectancy /Experiece Questionnaire(W-DEQ), at the beginning of the study and the end of the study (5 weeks after beginning the study).
The researchers dose not aware about randomized allocation because of closed packets. At the end of the study, the questionnaires will complete by another person except researcher. Also, the analyzer dose not aware about the people in the groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: gestational age between 26 to 33 weeks, level of education higher than primary school, informed consent. Exclusion criteria: previous cesarean delivery, complete bed rest during pregnancy
Intervention groups
Intervention group: Combination of standard medical care of prenatal care with motivational interviewing. Control group: standard medical care
Main outcome variables
Self-efficacy, stress, anxiety, fear of childbirth
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110228005931N5
Registration date:2018-09-04, 1397/06/13
Registration timing:registered_while_recruiting
Last update:2018-09-04, 1397/06/13
Update count:0
Registration date
2018-09-04, 1397/06/13
Registrant information
Name
Mahbobeh Faramarzi
Name of organization / entity
Babol University of medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 1329 4456
Email address
m.faramarzi@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-28, 1397/06/06
Expected recruitment end date
2018-12-21, 1397/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
ُStudy the effect of group counseling based on motivational interviewing approach on self-efficacy, anxiety, and fear of childbirth, in pregnant women
Public title
The effect of motivational counseling on fear of childbirth
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Gestational age between 26 to 33 weeks
level of education higher than primary school
informed consent
Age between 18 to 50 years
Exclusion criteria:
Previous cesarean delivery
Complete bed rest during pregnancy
Age
From 18 years old to 50 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
An independent statistician to research team allocates participants based on simple random method using computer, with random allocation sequence and equal probability (1:1), into two groups A and B (Intervention and control).
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
Ethic Committe of Babol University of Medical Sciences
Street address
Babol University of Medical Sciences, Ganjafroz Avenue, Babol, Mazandaran, Iran, Babol
City
Babol
Province
Mazandaran
Postal code
47176-47745
Approval date
2018-08-19, 1397/05/28
Ethics committee reference number
IR.MUBABOL.HRI.REC.1397.116
Health conditions studied
1
Description of health condition studied
Fear of childbirth
ICD-10 code
F40.9
ICD-10 code description
Phobic anxiety disorder, unspecified
Primary outcomes
1
Description
ُSelf-efficay of childbirth
Timepoint
At beginning of the study and end of the study (5 weeks after beginning)
Method of measurement
Childbirth Self-efficacy Inventory (CBSEI)
2
Description
Anxiety
Timepoint
At beginning of the study and end of the study (5 weeks after beginning)
Method of measurement
State-Anxiety of Spillberger
3
Description
Stress
Timepoint
At beginning of the study and end of the study (5 weeks after beginning)
Method of measurement
Revised Prenatal Distress Questionnaire (NUPDQ)
4
Description
Fear of childbirth
Timepoint
At beginning of the study and end of the study (5 weeks after beginning)
Method of measurement
Expectancy /Experience Questionnaire(W-DEQ)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The participants of this group will be receive combination of standard prenatal care with group counseling based on motivational interviewing for five sessions120 minutes, once a week.
Category
Behavior
2
Description
Control group: The participants of this group will be receive only standard prenatal care.