NCT06009887

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
148

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 15, 2021

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2021

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2021

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

August 19, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 24, 2023

Completed
Last Updated

August 24, 2023

Status Verified

August 1, 2023

Enrollment Period

5 days

First QC Date

August 19, 2023

Last Update Submit

August 23, 2023

Conditions

Keywords

PregnancyNatural birth beliefMedical birth beliefMotivational interview.

Outcome Measures

Primary Outcomes (2)

  • Belief Scale for Normal Delivery (BSND)

    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)

    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

Study Arms (2)

Experimental: İntervention Group

EXPERIMENTAL

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

No Intervention: Control Group

NO INTERVENTION

No interventions were made for those in the control group other than routine hospital practices.

Interventions

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.

Experimental: İntervention Group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Midwifery, Faculty of Health Sciences Sutcuimam University

Kahramanmaraş, Onikişubat, Turkey (Türkiye)

Location

Related Publications (1)

  • Rasouli M, AtashSokhan G, Keramat A, Khosravi A, Fooladi E, Mousavi SA. The impact of motivational interviewing on participation in childbirth preparation classes and having a natural delivery: a randomised trial. BJOG. 2017 Mar;124(4):631-639. doi: 10.1111/1471-0528.14397. Epub 2016 Nov 10.

Related Links

MeSH Terms

Interventions

Motivational Interviewing

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Çiğdem KARAKAYALI AY

    Department of Midwifery, Faculty of Health Sciences, Sutcuimam University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Research Assistant

Study Record Dates

First Submitted

August 19, 2023

First Posted

August 24, 2023

Study Start

February 15, 2021

Primary Completion

February 20, 2021

Study Completion

September 15, 2021

Last Updated

August 24, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

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.

Locations