Improving sleep for parents and infants through a sleep intervention
Efficacy of Parent-child Sleep Intervention to Improve Sleep Quality, Psychological Health, and Infant Health in Parents of Neonates.
This study is testing a new sleep program for parents and their newborns in a special care nursery to see if it can help them sleep better and improve their overall well-being.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 360 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Taipei Veterans General Hospital, Taiwan Government |
| Locations | 1 site (Taipei) |
| Trial ID | NCT06143917 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to develop and evaluate a parent-child sleep intervention designed to enhance sleep quality, psychological health, and overall infant health among parents of neonates in an intermediate care nursery. The study will involve 102 pairs of parents and infants, who will be randomly assigned to either an experimental group receiving the intervention or a control group. Various measures, including sleep quality indices and psychological assessments, will be utilized to gauge the effectiveness of the intervention, with data analyzed through statistical methods to determine outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are postpartum women aged 18 or older with a singleton pregnancy and infants at least 32 weeks gestational age who experience significant sleep disturbances.
Not a fit: Patients diagnosed with insomnia disorders, anxiety disorders, or depression, as well as those with certain medical conditions or working in shifts, may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve sleep quality and mental well-being for parents, leading to better health outcomes for both parents and their infants.
How similar studies have performed: Other studies have shown promising results with similar parent-child sleep interventions, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Postpartum women aged 18 years or older. * Postpartum women with a singleton pregnancy, and the gestational age of their infant is at least 32 weeks. * Postpartum women with a severe insomnia severity index score of ≥8 points. * Postpartum women and their husbands or partners capable of reading, understanding, and communicating in Mandarin. * Postpartum women and their husbands or partners with internet access and the ability to operate resources using a smartphone, tablet, or computer. * Both postpartum women and their husbands or partners are willing to participate in the research process. Exclusion Criteria: * Postpartum women diagnosed with Insomnia Disorder, Anxiety Disorders, or Depression. * Postpartum women suffering from arrhythmia or cardiovascular diseases. * Postpartum women working in shifts. * Infants with congenital abnormalities, neurological impairments (such as hydrocephalus, periventricular leukomalacia), requiring the use of tubes or respirators after discharge, or using medications that might affect sleep (such as caffeine, sedatives, muscle relaxant, anti-epileptic drugs, or pain medications).
Where this trial is running
Taipei
- Taipei Veterans General Hospital — Taipei, Taiwan (Recruiting)
Study contacts
- Principal investigator: Chien-Hui Chan — Study Principal Investigator
- Study coordinator: Chien-Hui Chan
- Email: g462110018@tmu.edu.tw
- Phone: +886 978579717
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.