Premature DeliveryNCT06635473
Effect of Intelligent Intervention Strategies on Self-efficacy and Hospital Readiness of Parents of Preterm Infants
A study testing Information support, Stress and coping and Specialist guidance in people with Premature Delivery, run by Shantou University Medical College.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Premature Delivery
- What is being tested?
- Information support, Stress and coping and Specialist guidance
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2024to 31 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- 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.
Who cannot join
- 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.
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of Intelligent Intervention Strategies on Self-efficacy and Hospital Readiness of Parents of Preterm Infants: a Randomized Controlled Trial
- 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.
- 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.
- Conditions
- Premature Delivery
- Being tested
- Information support, Stress and coping, Specialist guidance, Social support and interaction, Parentage development
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Information supportBehavioural
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.
Stress and copingBehavioural
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.
Specialist guidanceBehavioural
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.
Social support and interactionOther
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.
Parentage developmentBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | Routine nursing, discharge education |
| intervention group | Experimental | Intelligent interventions to enhance parents' hospital discharge readiness and self-efficacy. Receives: Behavioral: Information support; Behavioral: Stress and coping; Behavioral: Specialist guidance; Other: Social support and interaction; Behavioral: Parentage development |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: The day of admission, 24 hours before discharge, and 1 month after discharge
Secondary outcomes (5)
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.
Measured: 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.
Measured: 1 week, 1 month, 3 months after discharge
Readmission rate of preterm infants
Whether to be readmitted to hospital.
Measured: 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.
Measured: 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.
Measured: 1 week, 1 month, 3 months after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2024
- Study start1 Nov 2024 (estimated)
- Primary completion31 Oct 2025 (estimated)
- Study completion31 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Premature DeliveryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shantou University Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lin Kang, Shantou University Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06635473
- Sponsor's protocol ID
- SUMC
- Status last verified
- Sep 2024
- First submitted
- 29 Sep 2024
- Last updated
- 10 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40812802
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intelligent Intervention Strategies on Self-efficacy and Hospital Readiness of Parents of Preterm Infants: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06635473
- Acronym / sponsor ID
- SUMC
- Conditions
- Premature Delivery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Shantou University Medical CollegeUniversity, hospital or other
- Study start
- 1 Nov 2024 (estimated)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 10 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
- Clinical randomized controlled trials were conducted to verify and evaluate the feasibility and application effect of the intervention program.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –Routine nursing, discharge education |
| intervention group | Experimental | Behavioral: Information support, Behavioral: Stress and coping, Behavioral: Specialist guidance, Other: Social support and interaction, Behavioral: Parentage developmentIntelligent interventions to enhance parents' hospital discharge readiness and self-efficacy. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
- 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.
Key exclusion criteria (2 listed)
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Information supportThe 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. | Behavioural | intervention group |
| Stress and copingAccording 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. | Behavioural | intervention group |
| Specialist guidanceCarry 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. | Behavioural | intervention group |
| Social support and interactionSupport 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. | Other | intervention group |
| Parentage developmentSince 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. | Behavioural | intervention group |
Primary outcome
Parental readiness for discharge
Time frame: Upon admission and 24 hours before 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.
Parents' self-efficacy
Time frame: The day of admission, 24 hours before discharge, and 1 month after discharge
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.
5 secondary outcomes
Anxiety
Time frame: The day of admission, 24 hours before discharge, and 1 month after discharge
Growth and development indicators of premature infants
Time frame: 1 week, 1 month, 3 months after discharge
Readmission rate of preterm infants
Time frame: One month after discharge
Parental care ability
Time frame: The day of admission, 24 hours before discharge, and 1 month after discharge
Breastfeeding situation
Time frame: 1 week, 1 month, 3 months after discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2024.
- Derived from this study: PubMed 40812802Lin 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Information support, Stress and coping and Specialist guidance in people with Premature Delivery, run by Shantou University Medical College.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kang Lin (+8613411968515, 23klin@stu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parental readiness for discharge (time frame: Upon admission and 24 hours before discharge). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06635473, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2024.