Objectives: The effect of an individual- based consultation program on the fear of childbirth of nulliparous women
Design: A clinical trial on 96 pregnant women attended
Setting and conduct: A clinical trial on 96 pregnant women attended in health centers of Mashhad in order to investigate
Major Inclusion and Exclusion criteria: citizenship of Iran, age of 18-35, the first pregnancy, total score of 38-84 in Wijma Fear Questionnaire, version A.
Intervention:
Intervention group: Three consultation sessions of 45-60 minutes will be conducted once two weeks during weeks 28-30, 30-32, and 32-34 of pregnancy.
Control group: The control group will be under usual cares of health center.
The fear of childbirth will be evaluated and compared again during weeks 34-36 of pregnancy
main outcome measures: The fear of childbirth.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016042827653N1
Registration date:2016-09-02, 1395/06/12
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-09-02, 1395/06/12
Registrant information
Name
Nafise Androun
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3501 2534
Email address
androunn931@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice President of Research Mashhad University of Medical Sciences
Expected recruitment start date
2016-03-02, 1394/12/12
Expected recruitment end date
2017-01-01, 1395/10/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of individual consultation on the reduced fear of childbirth among nulliparous women
Public title
The effect of individual consultation on the reduced fear of childbirth among nulliparous women
Purpose
Prevention
Inclusion/Exclusion criteria
Iinclusion criteria: the Iranian 18-35 years old women from Mashhad who show their informed consent to participate in this study؛ to have (herself or one of his family members) a phone number to contact ; 26-28th Gestational week based on EDC or sonography; singleton pregnancy; 5th grade of education or more; low-risk pregnancy؛ and their total score of Wijma Fear Questionnaire؛version A is 38-84.
Exclusion criteria : the past or present clinical disease؛; past or present mental illness; taking special medications influencing on the mother’s mind؛; rug abuse or taking narcotics؛psychotropic or ecstasy drugs and alcohol drinking؛unpleasant or stressor events during the past 6 months before the study؛history of infertility؛score higher than 29 in Beck Depression Questionnaire and or cases requiring referral to a psychiatrist؛score greater than 29 in Beck Anxiety Questionnaire and or cases requiring referral to a psychiatrist؛ speech؛ hearing or accent disorders which inhibit establishment a relationship between researcher and subject؛obvious embryonic disorders in sonography test of the first three months of pregnancy؛score higher than 85 in Wijma Fear Questionnaire and or cases requiring referral to a Psychiatrist
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
96
Randomization (investigator's opinion)
Randomized
Randomization description
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 Mashhad University of Medical Sciences
Street address
Mashhad University of Medical Sciences, Daneshgah Street, Mashhad, Khorasan Razavi, Iran
City
Mashhad
Postal code
Approval date
2016-03-02, 1394/12/12
Ethics committee reference number
IR.MUMS.REC.1394.720
Health conditions studied
1
Description of health condition studied
fear
ICD-10 code
F40.2
ICD-10 code description
Phobias restricted to highly specific situations such as proximity to particular animals, heights, thunder, darkness, flying, closed spaces, urinating or defecating in public toilets, eating certain foods, dentistry, or the sight of blood or injury. Thoug
Primary outcomes
1
Description
fear of childbirth
Timepoint
weeks 28-30 of pregnancy and then weeks 34-36
Method of measurement
Wijma Fear Questionnaire, Version A
Secondary outcomes
1
Description
choosing childbirth method
Timepoint
weeks 28-30 and 34-36 of pregnancy
Method of measurement
Question
2
Description
attitude toward childbirth
Timepoint
weeks 28-30 of pregnancy and then weeks 34-36
Method of measurement
Question
3
Description
conflict in decision making
Timepoint
weeks 28-30 of pregnancy and then weeks 34-36
Method of measurement
Question
4
Description
self efficacy of choosing delivery method
Timepoint
weeks 28-30 of pregnancy and then weeks 34-36
Method of measurement
Question
5
Description
social support
Timepoint
weeks 28-30 of pregnancy and then weeks 34-36
Method of measurement
Question
6
Description
depression
Timepoint
weeks 28-30 of pregnancy and then weeks 34-36
Method of measurement
questionnaire bek
7
Description
anxiety
Timepoint
weeks 28-30 of pregnancy and then weeks 34-36
Method of measurement
questionnaire bek
Intervention groups
1
Description
The intervention group will be administered individual face to face consultation by the researcher based on the content of the consultation model in addition to usual care. Intervention will be performed through three sessions (45-60 minutes) every two weeks based on the mothers reference days to healthcare center during weeks 28-30, 30-32 and 32-34.Then, during weeks 34-36 of pregnancy questionnaires will be completed again by intervention and control.
Category
Behavior
2
Description
Control group will be administered by usual cares of the healthcare center. Then, during weeks 34-36 of pregnancy questionnaires will be completed again by intervention and control.