Ignite Creation Date:
2024-07-17 @ 11:06 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06487650
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-05
First Post:
2024-06-13
Brief Title:
The Development and Evaluation of Sleep Intervention for Perinatal Family
Sponsor:
Taipei Medical University
Organization:
Taipei Medical University
Study Overview
Official Title:
The Development and Evaluation of Sleep Intervention for Perinatal Family
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background Sleep disruptions and disturbances are highly prevalent among new mothers and fathers and negatively affect their mental health and infant development outcomes Effective sleep interventions are vital for family health
Objectives To develop a sleep intervention for mother-father-infant triads and to evaluate the effects on sleep improvement emotional distress and infant health outcomes
Methods In this proposal we plan to conduct a parallel-group two-arm randomized controlled trial on pregnant women and their partners Mother-father-infant triads will be recruited and randomly allocated to the intervention group receiving a sleep intervention or the control group Data will be collected with repeated measures and the relationship between studied variables will be analyzed with descriptive and inferential statistics
Anticipatory results The development and evaluation of an evidence-based sleep intervention will provide a scientific insight into sleep care for pregnant women and their families
Objectives To develop a sleep intervention for mother-father-infant triads and to evaluate the effects on sleep improvement emotional distress and infant health outcomes
Methods In this proposal we plan to conduct a parallel-group two-arm randomized controlled trial on pregnant women and their partners Mother-father-infant triads will be recruited and randomly allocated to the intervention group receiving a sleep intervention or the control group Data will be collected with repeated measures and the relationship between studied variables will be analyzed with descriptive and inferential statistics
Anticipatory results The development and evaluation of an evidence-based sleep intervention will provide a scientific insight into sleep care for pregnant women and their families
Detailed Description:
The primary outcome is the severity of insomnia symptoms The secondary outcomes of parents sleep quality objective sleep indicators symptoms of depression and anxiety and heart rate variability will be collected Infant sleep quality infant feeding and infant health outcomes will also be assessed Data will be analyzed using descriptive and inferential statistics
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None