- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06009887
Motivational Interview in Primiparous Pregnants With Low Belief in Normal Birth
August 23, 2023 updated by: Çiğdem KARAKAYALI AY, Inonu University
The Effect of Motivational Interviews of Primiparous Pregnants With Low Belief in Normal Birth on Medical and Natural Birth Beliefs
This study aims to determine the effect of motivational interviews made with primiparous pregnant women with low belief in normal birth on medical and natural birth belief.
This randomized controlled study was conducted in a randomized controlled manner with a total of 148 pregnant women who applied to the obstetrics outpatient clinic of a hospital in eastern Turkey (74 trials, 74 controls).
In the study, a total of four sessions of motivational interviews were conducted with the primiparous pregnant women in the experimental group, one week apart.
No intervention was applied to the women in the control group.
Research data Personal Information Form, Belief Scale for Normal Delivery (BSND) and Birth Beliefs (Natural and medical birth belief) Scale (BBS) were used.
Descriptive statistics, Pearson's chi-square test, and dependent and independent t-test were used to analyze the data.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
148
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Onikişubat
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Kahramanmaraş, Onikişubat, Turkey
- Department of Midwifery, Faculty of Health Sciences Sutcuimam University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Having a low level of belief and tendency towards normal birth according to the Normal Birth Belief Scale (between 24-56 points),
- Primiparous pregnant,
- According to the calculations made by USG of the pregnant women who do not know the last menstruation date or the last menstruation date, 24-36 days of pregnancy. in the week,
- Pregnant women who volunteered were included in the sample of the study.
Exclusion Criteria:
- Premature birth,
- Having any risk diagnosed during pregnancy (such as preeclampsia, diabetes, heart disease, placenta previa, oligohydramnios),
- Contraindications for normal vaginal delivery
- Developing cesarean indication,
- Not completing MG sessions,
- Pregnant women with deficiencies or errors in any of the forms in which the data were obtained were excluded from the sample.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental: İntervention Group
Motivational interviewing is a counseling approach that pays special attention to the language of change, adopts a collaborative, goal-oriented communication style and aims to strengthen personal motivation and commitment to this change, revealing and discovering the reasons for the change in one's own, in an atmosphere of acceptance and empathy.
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Motivational interviewing is a collaborative speaking style to strengthen one's own motivation and commitment to change.
Motivational interviewing is not a technique but a fundamental therapeutic style that does not try to make people change their behavior against their will.
Proven to be effective in many areas of healthcare, motivational interviewing is widely used to help people resolve their indecision about change, explore their concerns, and set their own goals.
The purpose of the motivational interviews conducted in the study is to increase the belief in normal and natural birth by enabling pregnant women to understand the factors that affect their low belief in normal birth, to take action for change and to believe in change, and to minimize the practices that cause medicalization of birth such as cesarean section by reducing medical birth beliefs.
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No Intervention: No Intervention: Control Group
No interventions were made for those in the control group other than routine hospital practices.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Belief Scale for Normal Delivery (BSND)
Time Frame: up to 4 weeks
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It was developed to evaluate the beliefs and tendencies of pregnant women towards normal birth.
The scale is a five-point Likert type and is scored as I completely agree (5), agree (4), undecided (3), disagree (2), strongly disagree (1).
A minimum of 24 and a maximum of 120 points can be obtained from the scale.
If the total score from the scale is between 24 and 56, low, between 57 and 88, moderate, and between 89 and 120, high-level beliefs and tendency towards normal birth are in question.
As the average score obtained from the scale increases, the beliefs and tendencies of pregnant women about normal birth increase.
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up to 4 weeks
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Birth Beliefs (Natural and medical birth belief) Scale (BBS)
Time Frame: Baseline and 4 weeks
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While one of the sub-dimensions of the scale used to evaluate the basic belief levels of women about childbirth evaluates birth as a natural process, the other sub-dimension considers birth as a medical/medical process.
The scale consists of 11 items in total, including 5 items (items 3, 5, 7, 8, and 11) for the belief in the natural process of birth and 6 items (items 1, 2, 4, 6, 9, and 10) for the belief in the medical/medical process.
consists of.
The scale score is obtained by dividing the total score of the items belonging to each sub-dimension by the number of items belonging to that sub-dimension.
The group with a high numerical value in the arithmetic mean result constitutes the birth belief of the woman.
In this Likert-type scale, each item is scored between 1 and 5 scales.
The option "strongly disagree" receives 1 point, while the option "strongly agree" receives 5 points.
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Baseline and 4 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Çiğdem KARAKAYALI AY, Department of Midwifery, Faculty of Health Sciences, Sutcuimam University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 15, 2021
Primary Completion (Actual)
February 20, 2021
Study Completion (Actual)
September 15, 2021
Study Registration Dates
First Submitted
August 19, 2023
First Submitted That Met QC Criteria
August 23, 2023
First Posted (Actual)
August 24, 2023
Study Record Updates
Last Update Posted (Actual)
August 24, 2023
Last Update Submitted That Met QC Criteria
August 23, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- 2020/1198
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
There is no plan to make individual participant data (IPD) available to other researchers.
Because the institution where the research was conducted does not allow this.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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