Clinical trial NCT06487650: The Development and Evaluation of Sleep Intervention for Perinatal Family
Official title: The Development and Evaluation of Sleep Intervention for Perinatal Family
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Sleep
Psychological Distress
Perinatal Problems
Keywords: sleep quality
perinatal
depression
anxiety
infant sleep
infant health
Lead sponsor: Taipei Medical University
Sponsor class: OTHER
First posted: 2024-07-05
Enrollment: 600
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: Inclusion Criteria:

1. First-time mothers and their partners aged 20 and older;
2. Currently 30 weeks gestation or more, singleton;
3. insomnia severity index score greater than 10;
4. living with a husband or partner;
5. Both women and their partners are willing to participate in and adhere to the research protocol;
6. be able to read and speak the Mandarin language

Exclusion Criteria:

1. sleep disorders, depression or anxiety disorders;
2. medical diseases with abnormal heart rate variability, or arrhythmia;
3. taking medicines that may affect the autonomic nervous system or
4. night shift workers;
5. obstetric complications, including gestational hypertension, preterm labor, labor complications, or postpartum complications;
6. infants with fetal deformity, or neonatal complications;
7. no access to Internet resources

Primary outcomes:
measure: Insomnia Severity Index
timeFrame: baseline, at 36-weeks' gestation, 2-week postpartum, 1-month, 3-month,6-month, and 12-month postpartum
Secondary outcomes:
measure: Sleep quality
timeFrame: baseline, at 36-weeks' gestation, postpartum 1 month, 3 months, 6 months, and 12-months
measure: Sleep duration using actigraphy
timeFrame: baseline, postpartum 1 month, 3 months, and 6 months.
measure: Sleep sleep onset latency using actigraphy
timeFrame: baseline, postpartum 1 month, 3 months, and 6 months.
measure: Sleep efficacy using actigraphy
timeFrame: baseline, postpartum 1 month, 3 months, and 6 months.
measure: Wake after sleep onset using actigraphy
timeFrame: baseline, postpartum 1 month, 3 months, and 6 months.
measure: Infants sleep Questionnaire
timeFrame: postpartum 1 month, 3 months, 6 months, and 12-months
measure: Depressive symptoms
timeFrame: baseline, at 36-weeks' gestation, postpartum 1 month, 3 months, 6 months, and 12-months
measure: Anxiety symptoms
timeFrame: baseline, at 36-weeks' gestation, postpartum 1 month, 3 months, 6 months, and 12-months
measure: Heart rate variability (HRV) measures
timeFrame: at baseline, postpartum 1 month, 3 months, and 6 months
measure: Infant weight
timeFrame: postpartum 3 months, 6 months, and 12-months
measure: Infant height
timeFrame: postpartum 3 months, 6 months, and 12-months
measure: Infant development
timeFrame: postpartum 3 months, 6 months, and 12-months
measure: Infant feeding
timeFrame: postpartum 1 month, 3 months, and 6 months, and 12 months
measure: Satisfaction of sleep intervention
timeFrame: immediately after interventions
Other outcomes:
Locations:
Study officials:
affiliation: Taipei Medical University
name: Shu-Yu Kuo, Phd
role: PRINCIPAL_INVESTIGATOR
References: