RecruitingNot Applicable

Effects of Intelligent Parent-child Bonding Intervention on the Physical, Psychological and Social Health of Parents of Premature Infants During Hospitalization and Return Home

Taiwan360 participantsStarted 2025-05-25

Plain-language summary

The study purpose is to construct and validate the effects of "intelligent parent-child bonding intervention" on the physical, psychological and social health of parents of premature infants.

Who can participate

Age range

20 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: 1. Parents of premature infants born less than 37 weeks of age; 2. Parents of premature infants aged 20 or above and able to communicate in Mandarin and Taiwanese; 3. Parents of premature infants agree to participate in this study and sign the research consent form; 4. The child is currently in the Pediatric and Neonatal Intensive Care Center Exclusion Criteria: 1. The premature baby has congenital abnormalities or is in critical condition and cannot survive; 2. The parents cannot use mobile phones or other Internet devices; 3. The parents have a history of mental illness, intellectual disability or substance abuse.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The Pittsburgh Sleep Quality Index, PSQI

Timeframe: Changes in parents' sleep patterns before premature infants are discharged from hospital and in the first month after premature infants return home

Actigraphy and Sleep Diary measures sleep details

Timeframe: Changes in parents' sleep details before premature infants are discharged from hospital and in the first month after premature infants return home

Brief Fatigue Inventory, BFI

Timeframe: Changes in parental fatigue before premature infants were discharged from hospital and in the first month after they returned home

Perceived Stress Scale, PSS

Timeframe: Changes in parental perceived stress before premature infants were discharged from hospital and in the first month after they returned home

Postpartum Specific Anxiety Scale

Timeframe: Changes in parental anxiety before premature infants were discharged from hospital and in the first month after they returned home

Edinburgh Postpartum Depression Scale

Timeframe: Changes in parental depression before premature infants were discharged from hospital and in the first month after they returned home

Trial details

NCT IDNCT06987227

SponsorNational Defense Medical Center, Taiwan

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-03-31

Contact for this trial

Lan Hsiang-Yun, A.P.

+886287923100 Ext. 18781 shinnylan@gmail.com

View on ClinicalTrials.gov More Parents of Premature Infants trials