NCT06479746

Brief Summary

Introduction: Women begin to experience fear long before birth, and the reason for their fear may be related to their baby, themselves, their partner/relatives, and the healthcare professional. Fear can disrupt the natural process of birth, prolong the stages of birth and cause postpartum complications.The research was conducted to determine the effect of emotional support given during birth on the woman's birth duration, perception and fear. Methods:The population of the randomized controlled experimental study consisted of nulliparous women who applied for normal spontaneous birth to the Birth Unit of a State Hospital in the Central Anatolia Region of Turkey (40 experimental subjects, 40 control subjects).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2020

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

July 1, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

June 24, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 28, 2024

Completed
Last Updated

June 28, 2024

Status Verified

June 1, 2024

Enrollment Period

6 months

First QC Date

June 24, 2024

Last Update Submit

June 24, 2024

Conditions

Keywords

BirthEmotional supportBirth perceptionFear of birthBirth duration

Outcome Measures

Primary Outcomes (2)

  • Wijma Delivery Expectancy/Experience Questionnaire version A (W-DEQ-A)

    The W-DEQ-A is a validated, to determine the level of birth fear experienced by pregnant women.Answers in the scale are numbered from 0 to 5 and are in a six-point Likert type. The minimum score that can be obtained from the scale is 0, and the maximum score is 165.

    Baseline

  • Women's Perceptions Scale on Supportive Care Provided at Birth

    The scale, which consists of 33 items, has three sub-dimensions: "comforting, informing and disturbing behaviors". Answers in the scale are numbered from 1 to 4 and are in a four-point Likert type. The minimum score that can be obtained from the scale is 33, and the maximum score is 132.

    Baseline

Secondary Outcomes (2)

  • Wijma Birth Expectation/Experience Scale (W-DEQ) Version B

    Within 2-4 hours after birth

  • Women's Perceptions Scale on Supportive Care Provided at Birth

    Within 2-4 hours after birth

Study Arms (2)

Emotional support group

EXPERIMENTAL

Empathetic approach, listening to the feelings and thoughts, welcoming the woman's behavior and expressions, telling her that she is breathing correctly, etc.), not judging the woman, being honest, using a soft and calm tone of voice, taking the baby or asking her opinion, encouraging her to endure the birth process, touching the woman and making physical contact, allowing her to practice her beliefs, showing the baby to the mother as soon as it is born and placing it in her arms.

Behavioral: Emotional support

Standard of care Group

NO INTERVENTION

The control group did not receive any treatment.

Interventions

Emotional support helps the woman giving birth effectively, meets her emotional needs and expectations, ensures her comfort, improves birth outcomes, increases her self-esteem, ensures a positive birth experience and facilitates her transition into the role of motherhood.

Also known as: Control Group
Emotional support group

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Nulliparous,
  • Between the ages of 18-35,
  • Admitted to the delivery room for normal spontaneous vaginal birth,
  • Do not have any physical health problems for themselves or their baby,
  • Does not have a diagnosed mental illness,
  • Not having a risky pregnancy,
  • Able to speak and read Turkish,
  • Cervical dilatation of 4 cm or more,
  • Women who were willing to participate in the study were included in the study.

You may not qualify if:

  • Multiparity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sukran Ertekin Pinar

Sivas, 58140, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Sukran Ertekin Pinar

    Cumhuriyet 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
Assoc. Prof. Dr.

Study Record Dates

First Submitted

June 24, 2024

First Posted

June 28, 2024

Study Start

July 1, 2020

Primary Completion

December 30, 2020

Study Completion

December 30, 2020

Last Updated

June 28, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

There is not a plan to make IPD available.

Locations