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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
148

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Turkey
    • Onikişubat
      • Kahramanmaraş, Onikişubat, Turkey
        • Department of Midwifery, Faculty of Health Sciences Sutcuimam University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: Motivational Interview
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.
No Intervention: No Intervention: Control Group
No interventions were made for those in the control group other than routine hospital practices.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Belief Scale for Normal Delivery (BSND)
Time Frame: up to 4 weeks
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.
up to 4 weeks
Birth Beliefs (Natural and medical birth belief) Scale (BBS)
Time Frame: Baseline and 4 weeks
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.
Baseline and 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Inonu University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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.

General Publications

Helpful Links

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 15, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 20, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 15, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 19, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 23, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 24, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 24, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 23, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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