- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07272252
Narrative Nursing for Cesarean Mothers' Anxiety and Breastfeeding Confidence (NARRCARE)
Psychological Effects and Breastfeeding Self-Efficacy of a Structured Four-Step Narrative Nursing Intervention in Cesarean Mothers: A Randomized Controlled Mixed-Methods Study
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: X i Huang
- Phone Number: +86-156-8090-6987
- Email: 24520241154909@stu.xmu.edu.cn
Study Contact Backup
- Name: Yinchun Tan
- Phone Number: +86-152-8329-4749
- Email: 2027687568@qq.com
Study Locations
-
-
Sichuan
-
Nanchong, Sichuan, China, 637600
- Recruiting
- Yilong County Maternal and Child Health Hospital
-
Contact:
- Yinchun Tan
- Phone Number: +86-152-8329-4749
- Email: 2027687568@qq.com
-
Contact:
- Xi Huang
- Phone Number: +86-156-8090-6987
- Email: 24520241154909@stu.xmu.edu.cn
-
Principal Investigator:
- Xi Huang
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Routine perinatal care
Participants receive standard ward education, nursing care, discharge instructions, and routine telephone follow-up without any additional narrative sessions.
|
|
|
Experimental: 4-step narrative nursing
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postpartum anxiety at 48 hours
Time Frame: 48 hours post-surgery
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postpartum depression risk
Time Frame: 48 hours, 2 weeks, 3 months postpartum
|
Proportion of women with Edinburgh Postnatal Depression Scale (EPDS) ≥ 10 at 48 hours, 2 weeks and 3 months.
|
48 hours, 2 weeks, 3 months postpartum
|
|
Breastfeeding self-efficacy
Time Frame: 48 hours, 2 weeks, 3 months postpartum
|
Mean score on the Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF, 14 items) at 48 hours, 2 weeks and 3 months.
Higher scores indicate greater confidence.
|
48 hours, 2 weeks, 3 months postpartum
|
|
Pain intensity
Time Frame: 48 hours and 2 weeks postpartum
|
Mean Numerical Rating Scale (NRS, 0-10) for self-reported pain at 48 hours and 2 weeks.
|
48 hours and 2 weeks postpartum
|
|
Breastfeeding continuation rate
Time Frame: 3 months postpartum
|
Percentage of women who report any breastfeeding at 3 months.
|
3 months postpartum
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- XMUNARRCARE2025
- FJ2022B061 (Other Grant/Funding Number: Fujian Provincial Social Science Foundation)
- XMSHLXH2320 (Other Grant/Funding Number: Xiamen Nursing Association)
- Basic Nursing II (Other Grant/Funding Number: Fujian First-Class Undergraduate Program)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing 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.
IPD Sharing 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.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Postpartum Anxiety
-
Women and Infants Hospital of Rhode IslandNot yet recruitingPostpartum Anxiety | Paternal Postpartum Depression
-
Saglik Bilimleri UniversitesiNot yet recruitingPostpartum Anxiety
-
Saglik Bilimleri UniversitesiNot yet recruitingMaternal Behavior | Psychological Stress | Postpartum Anxiety | Postpartum Period
-
St. Joseph's Healthcare HamiltonRecruiting
-
Marta MarciniakUniversity of ZurichRecruitingStress | Postpartum Anxiety | Postpartum Depressive DisorderSwitzerland
-
Afyonkarahisar Health Sciences UniversityNot yet recruitingPostpartum Depression | Postpartum Anxiety
-
Ministry of Science and Technology, TaiwanFu Jen Catholic UniversityRecruitingInfant Conditions | Breastfeeding | Postpartum AnxietyTaiwan
-
St. Joseph's Healthcare HamiltonRecruitingAnxiety Disorders | Postpartum AnxietyCanada
-
Karabuk UniversityNot yet recruitingPreoperative Anxiety | Postpartum Pain | Maternal Comfort | Cesarean Birth
-
Women's College HospitalCanadian Institutes of Health Research (CIHR); Michael Garron HospitalCompletedPostpartum Depression | Postpartum Anxiety | Postpartum Blues | Postpartum Mood DisorderCanada
Clinical Trials on 4-step narrative nursing program
-
Shanxi Medical UniversityRecruitingChronic Kidney Diseases | Maintenance Hemodialysis | Narrative NursingChina
-
The Fourth Hospital of ShijiazhuangCompletedProfessional BurnoutChina
-
Nanjing Medical UniversityCompletedAlzheimer Disease | Depression, Anxiety | NarrativeChina
-
Government College University FaisalabadRecruitingSocial Media AddictionPakistan
-
Government College University FaisalabadNot yet recruiting4-STEP-Training Program for Social Media AddictionPakistan
-
Mustafa Kemal UniversityNot yet recruitingType 2 Diabetes Mellitus (T2DM) | Diabetes Self-management | Diabetes EducationTurkey (Türkiye)
-
IRCCS Azienda Ospedaliero-Universitaria di BolognaRecruitingHaematological Malignancies | SarcomasItaly
-
University of Arkansas, FayettevilleNational Cancer Institute (NCI); University of California, Los Angeles; Thomas... and other collaboratorsActive, not recruitingVaccine-Preventable Diseases | Human Papilloma VirusUnited States
-
Mehtap GümüşayCompletedQuality of Life | Nursing Caries | Surgical MenopauseTurkey
-
National Taiwan University HospitalCompleted