NCT06635473

Brief Summary

  1. 1.Construct intelligent management intervention plan for parents of preterm infants from hospital to family based on the medical and health system suitable for China's national conditions.
  2. 2.Clinical randomized controlled trials were conducted to verify and evaluate the feasibility and application effect of the intervention program.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2024

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

September 29, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 10, 2024

Completed
22 days until next milestone

Study Start

First participant enrolled

November 1, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2025

Completed
Last Updated

October 10, 2024

Status Verified

September 1, 2024

Enrollment Period

12 months

First QC Date

September 29, 2024

Last Update Submit

October 8, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Parental readiness for discharge

    The Discharge Readiness Scale - Parent Edition This scale was developed by Weiss Equals in 2006 to assess the discharge readiness of parents of hospitalized children aged 0-18 years. The scale consists of 5 dimensions and 29 items. The scale was scored on a Likert 10-level scale, with scores ranging from 0 to 10 for each item (" complete "to" incomplete ") and an overall score ranging from 0 to 290. The higher the score, the higher the parents' readiness to leave the hospital. Cronbach's α coefficient of the total volume table was 0.85, and Cronbach's α coefficient of each dimension (personal status of parents, personal status of children, knowledge, coping ability and expected support) was 0.71, 0.70, 0.85, 0.86 and 0.84, respectively, indicating good reliability. Chinese scholar Chen et al. Sinicized the scale and verified its good reliability and validity.

    Upon admission and 24 hours before discharge

  • Parents' self-efficacy

    First developed by German clinical and health psychologist Ralf Schwarzer in 1981, the General self-efficacy Scale has been translated into at least 25 languages and is widely used internationally. In this study, the Chinese version of GSEA was adopted, which was jointly revised by Zhang Jianxin and Schwarzer, and has been proved to have good reliability and validity. The scale has one dimension, a total of 10 items, grades 1 to 4, the test subjects according to their actual situation, "completely correct" counts for 4 points, "mostly correct" counts for 3 points, "somewhat correct" counts for 2 points, "completely incorrect" counts for 1 point, all items are positive, the lowest theoretical score is 10 points. The highest score was 40, and the higher the score, the better the general sense of self-efficacy.

    The day of admission, 24 hours before discharge, and 1 month after discharge

Secondary Outcomes (5)

  • Anxiety

    The day of admission, 24 hours before discharge, and 1 month after discharge

  • Growth and development indicators of premature infants

    1 week, 1 month, 3 months after discharge

  • Readmission rate of preterm infants

    One month after discharge

  • Parental care ability

    The day of admission, 24 hours before discharge, and 1 month after discharge

  • Breastfeeding situation

    1 week, 1 month, 3 months after discharge

Study Arms (2)

control group

NO INTERVENTION

Routine nursing, discharge education

intervention group

EXPERIMENTAL

Intelligent interventions to enhance parents' hospital discharge readiness and self-efficacy.

Behavioral: Information supportBehavioral: Stress and copingBehavioral: Specialist guidanceOther: Social support and interactionBehavioral: Parentage development

Interventions

The experimental group was given intervention measures. According to the general data survey, discharge readiness and self-efficacy assessment, parents were divided into low, middle and high discharge readiness groups and low, middle and high self-efficacy groups, respectively, using WeChat mini programs to push different content.

intervention group

According to the results of self-efficacy and anxiety assessment, different interventions were based on different scores. Give encouragement and affirmation to parents with low anxiety and high self-efficacy. Parents with high anxiety and low self-efficacy should push stress relief methods such as mindfulness relaxation therapy in time. And through the wechat mini program to provide parents to respond to the pressure of the problem, the medical staff to give timely feedback.

intervention group

Carry out offline science popularization education and specialized training, and highly qualified specialist doctors and nurses will train parents, and parents will be assessed after training, and personalized guidance will be given according to the weak points of each parent\'s assessment.

intervention group

Support and encouragement for parents continue from admission to discharge, so that parents feel that even after discharge, there are people to accompany and support them.

intervention group

Since parents and children are separated during the hospitalization of preterm infants, we will create an environment where parents still play the role of parents, and stimulate parental competence through kangaroo care, parental touch, and breastfeeding.

intervention group

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Lin K, Zhang S, Zhang Z, Zheng W, Chen Z, Lin Z, Zhang H, Lin N. Implementing intelligent nursing interventions to enhance self-efficacy and hospital readiness in parents of preterm infants: a randomised controlled trial protocol. BMJ Open. 2025 Aug 13;15(8):e101498. doi: 10.1136/bmjopen-2025-101498.

MeSH Terms

Conditions

Premature Birth

Interventions

Coping SkillsDrug Interactions

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesPharmacological PhenomenaPharmacological and Toxicological PhenomenaPhysiological Phenomena

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

September 29, 2024

First Posted

October 10, 2024

Study Start

November 1, 2024

Primary Completion

October 31, 2025

Study Completion

October 31, 2025

Last Updated

October 10, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share