The Development and Evaluation of Sleep Intervention for Perinatal Family
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: sleep intervention, Control group.
- Who it may be relevant to
- Registry conditions: Sleep, Psychological Distress, Perinatal Problems. Basic parameters: from 20 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
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.
Interventions
- Behavioral sleep intervention
At the beginning of the intervention, participants will have an orientation and overview of the program. Then, participants will follow the curriculum of modules, and professional feedback to complete the intervention. - Behavioral Control group
Participants in control group will follow standardized usual care and a perinatal health booklet
Primary outcome measures
- Insomnia Severity Index [Time frame: baseline, at 36-weeks' gestation, 2-week postpartum, 1-month, 3-month,6-month, and 12-month postpartum]
Secondary outcome measures (12)
- Sleep quality [Time frame: baseline, at 36-weeks' gestation, postpartum 1 month, 3 months, 6 months, and 12-months]
- Sleep duration using actigraphy [Time frame: baseline, postpartum 1 month, 3 months, and 6 months.]
- Sleep sleep onset latency using actigraphy [Time frame: baseline, postpartum 1 month, 3 months, and 6 months.]
- Sleep efficacy using actigraphy [Time frame: baseline, postpartum 1 month, 3 months, and 6 months.]
- Wake after sleep onset using actigraphy [Time frame: baseline, postpartum 1 month, 3 months, and 6 months.]
- Infants sleep Questionnaire [Time frame: postpartum 1 month, 3 months, 6 months, and 12-months]
- Depressive symptoms [Time frame: baseline, at 36-weeks' gestation, postpartum 1 month, 3 months, 6 months, and 12-months]
- Anxiety symptoms [Time frame: baseline, at 36-weeks' gestation, postpartum 1 month, 3 months, 6 months, and 12-months]
- Heart rate variability (HRV) measures [Time frame: at baseline, postpartum 1 month, 3 months, and 6 months]
- Infant weight [Time frame: postpartum 3 months, 6 months, and 12-months]
- Infant height [Time frame: postpartum 3 months, 6 months, and 12-months]
- Infant development [Time frame: postpartum 3 months, 6 months, and 12-months]
Eligibility criteria
Inclusion criteria
- First-time mothers and their partners aged 20 and older;
- Currently 30 weeks gestation or more, singleton;
- insomnia severity index score greater than 10;
- living with a husband or partner;
- Both women and their partners are willing to participate in and adhere to the research protocol;
- be able to read and speak the Mandarin language
Exclusion criteria
- sleep disorders, depression or anxiety disorders;
- medical diseases with abnormal heart rate variability, or arrhythmia;
- taking medicines that may affect the autonomic nervous system or
- night shift workers;
- obstetric complications, including gestational hypertension, preterm labor, labor complications, or postpartum complications;
- infants with fetal deformity, or neonatal complications;
- no access to Internet resources
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Health services research
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06487650 · N202204079