Effect of Intelligent Intervention Strategies on Self-efficacy and Hospital Readiness of Parents of Preterm Infants

Effect of Intelligent Intervention Strategies on Self-efficacy and Hospital Readiness of Parents of Preterm Infants: a Randomized Controlled Trial

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. Clinical randomized controlled trials were conducted to verify and evaluate the feasibility and application effect of the intervention program.

Study Overview

• Status: Not yet recruiting
• Conditions: Premature Delivery
• Intervention / Treatment: Behavioral: Information support; Behavioral: Stress and coping; Behavioral: Specialist guidance; Other: Social support and interaction; Behavioral: Parentage development

Detailed Description

Based on the previous literature analysis, this study builds an intelligent intervention scheme based on evidence-based methods and theories. Finally, we selected the parents of preterm infants in the neonatology department of a third class hospital in Shantou to carry out a similar experiment to verify the scheme. With data collected at five critical time points and different interventions provided according to baseline data, the study will reveal significant differences in personalized interventions, self-efficacy at different time points, and hospital discharge readiness among parents of preterm infants in the context of intelligent intervention, showing the relationship between self-efficacy and hospital discharge readiness. This study will fill in the single, traditional model of education and provide new perspectives and methods for future research and clinical practice.

• Study Type: Interventional
• Enrollment (Estimated): 84
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kang Lin; Phone Number: +8613411968515; Email: 23klin@stu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Inclusion criteria for premature infants ① gestational age < 37 weeks；② Premature infants admitted to NICU；③ The duration of hospitalization is more than 5 days.
2. Inclusion and exclusion criteria of primary caregivers of preterm infants ① Preterm infants admitted to neonatology and family caregivers of preterm infants with gestational age < 37 weeks. ② Family members who volunteer to undertake primary care tasks. ③ No mental disorders and can carry out normal language communication； ④ ≥18 years old, proficient in WeChat use；⑤ Informed consent has been signed.

Exclusion Criteria:

1. Exclusion criteria for preterm infants ① intrauterine developmental retardation of preterm infants. ② Preterm infants with a history of major surgery. ③ Unplanned discharge, transfer, transfer or death of premature infants.
2. Exclusion criteria for primary caregivers of preterm infants ① There are recent major mental trauma injuries caused by non-hospitalization factors. ② the caregiver suffers from serious diseases of the heart, brain, lung, kidney and other organs. 3. Shedding criteria: Caregivers who voluntarily asked to withdraw for various reasons during the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: control group; Routine nursing, discharge education
Experimental: intervention group; Intelligent interventions to enhance parents' hospital discharge readiness and self-efficacy.	Behavioral: Information support; 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.; Behavioral: Stress and coping; 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.; Behavioral: Specialist guidance; 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.; Other: Social support and interaction; 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.; Behavioral: Parentage development; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety	Self-rating Anxiety Scales (SAS) The self-rating Anxiety Scales (SAS), compiled by William W.K. Zung in 1971, is a commonly used self-rating tool for adult anxiety symptoms. It includes 20 items and scores are divided into 1 to 4 levels. There are 15 positive items and 5 negative items in the scale. The 15 positive entries were scored as 1, 2, 3 and 4 points in turn, and the 5 reverse entries (5, 9, 13, 17 and 19) were scored as 4, 3, 2 and 1 points. The score of 20 entries is added to obtain the total score, standard score =SAS total score x 1.25 Take the integer part. Less than 50 is classified as no anxiety, 50 to 59 is classified as mild anxiety, 60 to 69 is classified as moderate anxiety, and more than 69 is classified as severe anxiety. Cronbach's α coefficient is 0.931.	The day of admission, 24 hours before discharge, and 1 month after discharge
Growth and development indicators of premature infants	The weight and length of premature infants were measured. Use the same brand weight scale and calibrate it regularly, taking the average of the two measurements as the measurement result.	1 week, 1 month, 3 months after discharge
Readmission rate of preterm infants	Whether to be readmitted to hospital.	One month after discharge
Parental care ability	Ability to care for premature infants: ability to care for premature infants refers to the ability of parents or primary caregivers to care for premature infants, including care knowledge, care skills, care attitude and other aspects. This study mainly studies the caring ability of parents of preterm infants and adopts the self-assessment questionnaire of family caring ability of preterm infants compiled by Meng Jingwen et al for quantitative measurement. The questionnaire includes 18 items in 3 parts: caring knowledge of preterm infants, caring technology and caring ability, and adopts Likert 5-level scoring method, with no understanding =1 point. Not very clear =2 points, general understanding =3 points, relatively understanding =4 points, very understanding =5 points. The total score is 18 to 90, and the higher the total score, the higher the caring ability. The content validity of the questionnaire was 0.98, and the Cronbach's α value of the questionnaire was 0.958.	The day of admission, 24 hours before discharge, and 1 month after discharge
Breastfeeding situation	Parents were asked about the feeding conditions of preterm infants after discharge, which were divided into three types: (1) exclusive breastfeeding, (2) formula feeding and (3) mixed feeding.	1 week, 1 month, 3 months after discharge

Collaborators and Investigators

• Sponsor: Shantou University Medical College

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2024
• Primary Completion (Estimated): October 31, 2025
• Study Completion (Estimated): October 31, 2025

Study Registration Dates

• First Submitted: September 29, 2024
• First Submitted That Met QC Criteria: October 8, 2024
• First Posted (Actual): October 10, 2024

Study Record Updates

• Last Update Posted (Actual): October 10, 2024
• Last Update Submitted That Met QC Criteria: October 8, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Premature Birth
• Other Study ID Numbers: SUMC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No