NCT07272252

Brief Summary

This study tests whether a nurse-led "4-step narrative nursing" program can reduce anxiety and improve breastfeeding confidence in mothers who are having a planned or non-emergency cesarean section. What is the problem? About 30-40% of Chinese cesarean mothers feel high anxiety after surgery, and 1 in 5 is at risk for postpartum depression. Low confidence in breastfeeding is also common. What will we do? We will randomly assign 160 mothers (1:1) to either: Usual care - standard education and ward care, or Usual care plus narrative nursing - four short (10-20 min) conversations with a trained nurse: Before surgery - help the mother talk about her fears. 24-48 h after surgery - encourage her to "name" pain or worries and separate them from herself. Before discharge - guide her to find positive moments and build a "strong-mom" story. Two weeks later by phone - strengthen the new story and review feeding success. What will we measure? Main result: anxiety score at 48 h (STAI scale). Other results: depression risk, breastfeeding confidence, pain, and feeding rates up to 3 months. Possible benefits: Lower anxiety, better mood, higher breastfeeding rates. No drugs or extra procedures are involved, only talking. Risks: Minimal; some mothers may feel emotional during conversations, but nurses can pause or refer to counselling if needed.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

October 1, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 26, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 9, 2025

Completed
23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

December 18, 2025

Status Verified

November 1, 2025

Enrollment Period

3 months

First QC Date

November 26, 2025

Last Update Submit

December 11, 2025

Conditions

Keywords

narrative nursingstorytelling interventioncesarean sectionpostpartum anxietybreastfeeding confidencemixed-methodsrandomized controlled trialChina

Outcome Measures

Primary Outcomes (1)

  • Postpartum anxiety at 48 hours

    Mean score on the State-Trait Anxiety Inventory (STAI-State, 20 items) assessed 48 hours after cesarean delivery. Lower scores indicate less anxiety.

    48 hours post-surgery

Secondary Outcomes (4)

  • Postpartum depression risk

    48 hours, 2 weeks, 3 months postpartum

  • Breastfeeding self-efficacy

    48 hours, 2 weeks, 3 months postpartum

  • Pain intensity

    48 hours and 2 weeks postpartum

  • Breastfeeding continuation rate

    3 months postpartum

Study Arms (2)

Routine perinatal care

NO INTERVENTION

Participants receive standard ward education, nursing care, discharge instructions, and routine telephone follow-up without any additional narrative sessions.

4-step narrative nursing

EXPERIMENTAL

Participants receive usual care plus four nurse-led narrative sessions (pre-op externalization, post-op deconstruction, pre-discharge reconstruction, and 2-week meaning-reconstruction phone call) aimed at reducing anxiety and enhancing breastfeeding confidence.

Behavioral: 4-step narrative nursing program

Interventions

Four nurse-led storytelling sessions (pre-operative externalization, post-operative deconstruction, pre-discharge reconstruction, and 2-week meaning-reconstruction phone call) aimed at reducing anxiety and increasing breastfeeding self-efficacy.

4-step narrative nursing

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Women aged 18-50 years
  • Scheduled for elective or non-emergency cesarean section at ≥37 weeks
  • Able to communicate in Mandarin and provide written informed consent
  • Expected hospital stay ≥24 h
  • Singleton pregnancy with stable maternal and neonatal condition allowing routine mother-baby contact

You may not qualify if:

  • Severe psychiatric disorders (schizophrenia, bipolar disorder, active suicidal ideation)
  • Maternal or neonatal need for ICU/NICU admission
  • Emergency cesarean section preventing baseline assessment
  • Communication or cognitive impairment precluding interview

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yilong County Maternal and Child Health Hospital

Nanchong, Sichuan, 637600, China

RECRUITING

MeSH Terms

Conditions

Depression, Postpartum

Condition Hierarchy (Ancestors)

Puerperal DisordersPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDepressive DisorderMood DisordersMental Disorders

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Single-center, two-arm, randomized, parallel-group, superiority trial with blinded outcome assessment.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Master's student

Study Record Dates

First Submitted

November 26, 2025

First Posted

December 9, 2025

Study Start

October 1, 2025

Primary Completion

January 1, 2026

Study Completion

March 1, 2026

Last Updated

December 18, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will share

Yes, we plan to share individual participant data (IPD). The de-identified IPD underlying published results will be made available to qualified researchers beginning 9 months after article publication and ending 36 months post-publication. Data access will be granted after approval of a methodologically sound proposal and execution of a data-sharing agreement. Interested parties should contact the corresponding author.

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
IPD and supporting information will be made available beginning 9 months after the primary results paper has been accepted for publication and ending 36 months after that date. An extension may be granted if a justifiable request is received before the closing date.
Access Criteria
Access is limited to qualified researchers with IRB/REC-approved, methodologically sound proposals relevant to the approved indication. Only de-identified participant data and the data dictionary will be provided. Requests should be e-mailed to 【corresponding-author@univ.edu】 with a 1-page protocol and statistical analysis plan. A data-sharing agreement outlining terms of use, confidentiality, and no attempt to re-identify participants must be signed before access is granted. Data will be shared through a password-protected secure cloud link; download is logged and audited.
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