An interventional study of 4-step narrative nursing program in Postpartum Anxiety, Postpartum Depression (PPD) and Breastfeeding Self-Efficacy, sponsored by Xi Huang. Recruiting at 1 site in China. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-16.
Sponsored by Xi Huang · Not applicable, Interventional, and Supportive care
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.
569 studies on the registry are indexed under Depression, Postpartum; 134 are open to participants now.
This study's planned enrollment of 160 is above the median of 104 across 454 interventional studies indexed under Depression, Postpartum.
Browse Depression, Postpartum studies →This is the only study on the registry with Xi Huang as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive standard ward education, nursing care, discharge instructions, and routine telephone follow-up without any additional narrative sessions.
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
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.
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.
Time frame: 48 hours post-surgery
Postpartum depression risk
Proportion of women with Edinburgh Postnatal Depression Scale (EPDS) ≥ 10 at 48 hours, 2 weeks and 3 months.
Time frame: 48 hours, 2 weeks, 3 months postpartum
Breastfeeding self-efficacy
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.
Time frame: 48 hours, 2 weeks, 3 months postpartum
Pain intensity
Mean Numerical Rating Scale (NRS, 0-10) for self-reported pain at 48 hours and 2 weeks.
Time frame: 48 hours and 2 weeks postpartum
Breastfeeding continuation rate
Percentage of women who report any breastfeeding at 3 months.
Time frame: 3 months postpartum
Plan to share: Yes — 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.
Supporting information: Study protocol, Informed consent form
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.
Data sharing details ↗ · med.xmu.edu.cn
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