NCT05216783

Brief Summary

Aim: The aim of this study to determine the effect of motivational interviews on the perception and self-efficacy of birth in nullipars with a perception of traumatic birth. Materials and Methods: The study was conducted in a randomized controlled, between November 2019 and November 2020 in the obstetrics outpatient clinics of Elazig Fethi Sekin City Hospital. In the power analysis, the sample size was calculated as at least 83 pregnant women for each group (83 experiment, 83 control). Data were collected with Descriptive Information Form, Traumatic Childbirth Perceptions Scale (TCPS) and Childbirth of Self-Efficacy Scale-Short From (CBSE). Pregnant women in the experimental group were held with four sessions of motivational interviews one week a part. No intervention was made for the pregnant women in the control group. Descriptive statistics, chi-square test, t test for dependent and independent groups were used in data analysis

Trial Health

87
On Track

Trial Health Score

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

Enrollment
166

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2019

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 12, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 12, 2021

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

December 16, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 1, 2022

Completed
Last Updated

February 1, 2022

Status Verified

January 1, 2022

Enrollment Period

12 months

First QC Date

December 16, 2021

Last Update Submit

January 18, 2022

Conditions

Keywords

ChildbirthMotivational InterviewingSelf-EfficacyPerceptionnullipara

Outcome Measures

Primary Outcomes (1)

  • Traumatic Childbirth Perception Scale (TCPS)

    It is used to evaluate the traumatic childbirth perception levels of the women at reproductive age. The scale has a total of 13 questions that cover thoughts and emotions such as anxiety, fear, and worry felt by the women while thinking about the concept of childbirth. Each question is scored from 0 (I am not afraid at all) to 10 points (I am very afraid). The mean of scores obtained from the scale indicates the traumatic childbirth perception level. The minimum and maximum scores to be obtained from the scale are successively 0 and 130 points. A high score obtained from the scale demonstrates that the pregnant woman has high-level traumatic childbirth perception. The scores ranging from 0 to 26, from 27 to 52, from 53 to 78, from 79 to 104, and from 105 to 130 consecutively refer to very low, low, moderate, high, and very high levels of traumatic childbirth perception

    Change from Traumatic Childbirth Perception at 4 weeks

Secondary Outcomes (1)

  • Short-Form Childbirth Self-Efficacy Inventory (CBSEI-32)

    Change from Short-Form Childbirth Self-Efficacy at 4 weeks

Study Arms (2)

Experimental

EXPERIMENTAL

The Personal Information Form, the Traumatic Childbirth Perception Scale (TCPS), and the short-form Childbirth Self-Efficacy Inventory (CBSEI-32) were utilized for the collection of research data. First of all, the TCPS was applied to the pregnant women, and the pregnant women who obtained a score above 53 points (moderate-level traumatic childbirth perception) from the TCPS were invited to the research. Next, the Personal Information Form and the CBSEI-32 were applied to the pregnant women who agreed to participate in the research. The motivational interviews were held with the pregnant women in the experimental group once a week for four weeks. No initiative was applied to the pregnant women in the control group. The TCPS and CBSEI-32 were applied to all participant pregnant women after four weeks following the first application. The application of the measurement tools took 10-15 minutes.

Behavioral: Motivational Interviews

Control

NO INTERVENTION

The researchers applied no initiative to the control group, and the pregnant women in the control group solely had the routine checks performed at the city hospital. At the end of the study, the questions of pregnant women in the cotrol group about childbirth were answered. Before applying the initiative to the experimental group, the researcher (SB) had had training about motivational interview techniques.

Interventions

The qualitative research studies performed on the traumatic childbirth experiences indicated that the pregnant women's interaction and communication with the midwives were more effective than the medical intervention methods that were applied.

Experimental

Eligibility Criteria

Age28 Weeks - 36 Weeks
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsNullipars woman
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • having the ability to communicate,
  • being within 28-36 weeks of pregnancy,
  • being aged 18 or above,
  • having a live singleton fetus,
  • having no pregnancy-related risk (pre-eclampsia, diabetes, cardiac disease, placenta previa, oligohydramnios, and so on),
  • having no problem about the fetus's health (fetal anomaly, intrauterine growth restriction, and so on),
  • having a medium or a higher level of traumatic childbirth perception according to the Traumatic Childbirth Perception Scale (≥53 points).

You may not qualify if:

  • The criterion for being excluded from the research was to have a condition that would prevent the woman from having a normal birth

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fırat University

Elâzığ, Province, 23119, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

  • Sümeyye barut, PhD

    Firat University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Model Details: This study was designed as a randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

December 16, 2021

First Posted

February 1, 2022

Study Start

November 12, 2019

Primary Completion

November 1, 2020

Study Completion

February 12, 2021

Last Updated

February 1, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations