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Not yet recruitingNCT06635473Updated Oct 10, 2024

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

An interventional study of Information support and Stress and coping in Premature Delivery, sponsored by Shantou University Medical College. Not yet recruiting. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2024-10-10.

Sponsored by Shantou University Medical College · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Primary completion was expected by Oct 2025, 1 year ago, but the record still lists the study as not yet recruiting.

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Phase
Not applicable
Study type
Interventional
Enrollment
84
Allocation
Randomized
Ages
18 Years to 100 Years
Sex
All
01

Study summary

  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.
Read the 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.

02

Conditions studied

  • Premature Delivery

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03

In context

Premature Birth

2,553 studies on the registry are indexed under Premature Birth; 502 are open to participants now.

This study's planned enrollment of 84 is close to the median of 84 across 1,669 interventional studies indexed under Premature Birth.

Browse Premature Birth studies →

Lead sponsor

Shantou University Medical College is the lead sponsor of 12 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No

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.

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 has been signed.

Exclusion criteria

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.
Terms in these criteria, in plain language(1)

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.

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.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
84 participants (estimated)

Study arms

  • 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 · Behavioral: Stress and coping · Behavioral: Specialist guidance · Other: Social support and interaction · Behavioral: Parentage development

Interventions

  • BehavioralInformation 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.

  • BehavioralStress 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.

  • BehavioralSpecialist 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\&#39;s assessment.

  • OtherSocial 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.

  • BehavioralParentage 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Upon admission and 24 hours before discharge

  2. 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.

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

Secondary outcomes

  1. 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.

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

  2. 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.

    Time frame: 1 week, 1 month, 3 months after discharge

  3. Readmission rate of preterm infants

    Whether to be readmitted to hospital.

    Time frame: One month after discharge

  4. 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.

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

  5. 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.

    Time frame: 1 week, 1 month, 3 months after discharge

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Nov 2024; primary completion for Oct 2025, 11 months later.

Of 744 non-industry interventional studies with no phase under Premature Birth, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 47. This study's planned 11 months is below that.

Counting every sponsor, half of 762 studies reached it within 24 months; a quarter within 12 and three quarters within 47.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 29, 2024
First posted
Oct 10, 2024
StartEst.
Nov 1, 2024
Primary completionEst.
Oct 31, 2025
CompletionEst.
Oct 31, 2025
Last update
Oct 10, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 10, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06635473
Lead sponsor
Shantou University Medical College
Responsible party
Lin Kang (Clinical Professor, Shantou University Medical College) — Principal investigator
First posted
Oct 10, 2024
Start date
Nov 1, 2024 (estimated)
Primary completion
Oct 31, 2025 (estimated)
Completion
Oct 31, 2025 (estimated)
Last update
Oct 10, 2024

Study contacts

Kang Lin
Contact
23klin@stu.edu.cn
+8613411968515

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.

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