Maternal Burnout, Breastfeeding Self-Efficacy and Attachm... | NCT07112495

Studies
Maternal Burnout, Breastfeeding Self-Efficacy and Attachment Level

NCT07112495

Sponsor

Sakarya University

Status

Completed

Last Update Posted

Jan 2, 2026Actual

Enrollment

80Actual

Phase

Not Applicable

Conditions

Pregnancy

Interventions

pregnant women with

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2024Actual

Primary Completion Date

Jan 1, 2025Actual

Completion Date

Feb 20, 2025Actual

First Submitted Date

May 14, 2025

First Submission Date that Met QC Criteria

Aug 1, 2025

First Posted Date

Aug 8, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 28, 2025

Last Update Posted Date

Jan 2, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Labor pain causes women to be afraid of vaginal delivery and to be anxious about delivery and therefore to prefer cesarean delivery (Ali Alahmari et al., 2020). The World Health Organization (WHO) has set the safe cesarean section rate for countries at 15% (World Health Organization, 2015). However, many countries are well above this rate (Betran et al., 2021). An important factor in the preference for cesarean deliveries is the fear of vaginal delivery (Zhao et al., 2021). Vaginal delivery with epidural anesthesia in primiparous women is a very good opportunity to prevent the preference of cesarean deliveries due to fear of vaginal delivery. Unless contraindicated, epidural analgesia should be offered to women to alleviate the pain felt with contractions during labor (Callahan et al., 2023).

Recently, women frequently prefer epidural anesthesia to avoid pain during vaginal delivery. Vaginal delivery with epidural anesthesia aims to minimize the pain of women during the trauma process and is the most effective pain method among pharmacological and nonpharmacological interventions (Antonakou, & Papoutsis, 2016). The reason why vaginal delivery with epidural anesthesia is not widespread enough is that women are not given enough information about epidural anesthesia (Shishido et al., 2020).

Detailed Description

Purpose: The aim of this study is to emphasize the importance of vaginal birth with epidural anesthesia in primiparous women (who will have their first birth) in order to reduce the effect of fear of vaginal birth on the choice of cesarean section and to evaluate the effect of increasing the level of knowledge about epidural anesthesia on birth preferences.

Objectives:

To determine the level of fear and anxiety of women regarding childbirth.

To examine the effect of fear of vaginal birth on the preference for cesarean section.

To evaluate the effectiveness of vaginal birth with epidural anesthesia in pain management.

To determine the level of knowledge of women about epidural anesthesia.

To increase the rate of preference for vaginal birth by providing information about epidural anesthesia.

To reveal the role of widespread use of epidural anesthesia in reducing cesarean section rates.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
intervention	Experimental	pregnant women receiving epidural	Other: pregnant women with
Control	No Intervention	no pregnant women receiving epidural

Interventions

Name	Type	Description	Arm Group Labels	Other Names
pregnant women with	Other	pregnant women with	intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To determine the breastfeeding self-efficacy levels of mothers.	Assessed using the Breastfeeding Self-Efficacy Scale The minimum possible score on the scale is 14, and the maximum is 70. There is no cutoff point for the scale, and a higher score indicates higher breastfeeding self-efficacy.	1 year
To evaluate maternal attachment levels.	Measured with a validated maternal attachment scale. The lowest possible score on the scale is 26, and the highest is 104. A higher score indicates a higher level of maternal attachment.	1 year
To examine the breastfeeding status of infants during the first six months of life.	Including exclusive breastfeeding, partial breastfeeding, and formula supplementation	1 year
To monitor infant growth and development through percentile tracking during the first six months.	Based on weight, height, and head circumference measurements compared with growth charts	1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Having a normal vaginal delivery in the delivery room,
19 to 45 years old
To be transferred to the Puerperium service after delivery,
The baby's APGAR score is 7 and above
37 and above weeks of gestation
No complications in the baby and mother due to childbirth
Postnatal care by the mother's side
Mother and baby sharing the same room after birth until discharge,
The mother is breastfeeding her baby,
Mother's voluntary participation in the study.

Exclusion Criteria:

Separation of mother and baby for any reason while the mother is with the baby
Transfer of the baby to the NICU
Wanting to get out of the study.
Being a single parent
Those who cannot speak and write Turkish

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

women in labor

Minimum Age

19 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Tiryaki	Sakarya	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sakarya University		Sakarya			Turkey (Türkiye)

References Module

Citations

Not provided

Label	URL
DOI: 10.14744/DAJPNS.2023.00212	View source
Related Info	View source

ID	Term
D010146	Pain
D000077062	Burnout, Psychological
D001942	Breast Feeding

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D013315	Stress, Psychological