An interventional study of sleep intervention and Control group in Sleep, Psychological Distress and Perinatal Problems, sponsored by Taipei Medical University. Not yet recruiting. Open to participants aged 20 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-14.
Sponsored by Taipei Medical University · Not applicable, Interventional, and Health services research
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.
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.
Taipei Medical University is the lead sponsor of 245 studies on the registry; 56 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants in the intervention group will receive both the standardized usual care and the sleep intervention. The intervention consists of sleep education, health professional support, and counseling. The intervention will be delivered from pregnancy to postpartum for mothers and fathers.
Behavioral: sleep intervention
Participants in the control group will receive a perinatal health booklet in addition to the standardized usual care.
Behavioral: Control group
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.
Participants in control group will follow standardized usual care and a perinatal health booklet
Insomnia Severity Index
The Chinese version of the Insomnia Severity Index (ISI) is used to measure the severity of insomnia symptoms, a higher score indicates more severe insomnia symptoms.
Time frame: baseline, at 36-weeks' gestation, 2-week postpartum, 1-month, 3-month,6-month, and 12-month postpartum
Sleep quality
The 19-item Chinese version of the Pittsburgh Sleep Quality Index (PSQI), will be used to measure sleep quality and sleep disturbance, higher score indicates worse sleep quality
Time frame: baseline, at 36-weeks' gestation, postpartum 1 month, 3 months, 6 months, and 12-months
Sleep duration using actigraphy
The Actiwatch will be used to collect objective data of sleep duration
Time frame: baseline, postpartum 1 month, 3 months, and 6 months.
Sleep sleep onset latency using actigraphy
The Actiwatch will be used to collect objective data of sleep onset latency
Time frame: baseline, postpartum 1 month, 3 months, and 6 months.
Sleep efficacy using actigraphy
The Actiwatch will be used to collect objective data of sleep efficacy
Time frame: baseline, postpartum 1 month, 3 months, and 6 months.
Wake after sleep onset using actigraphy
The Actiwatch will be used to collect objective data of wake after sleep onset
Time frame: baseline, postpartum 1 month, 3 months, and 6 months.
Infants sleep Questionnaire
Parents will be asked to rate their infant's sleep quality using the 19-item Brief Infant Sleep Questionnaire-Revised (BISQ-R). The BISQ will be used to assess sleep duration, duration of sleep by circadian rhythm, and night-time awakenings
Time frame: postpartum 1 month, 3 months, 6 months, and 12-months
Depressive symptoms
Maternal and paternal depressive symptoms will be assessed using the Taiwanese version of the 10-item Edinburgh Postnatal Depression Scale (EPDS), a higher score indicated more severe symptoms.
Time frame: baseline, at 36-weeks' gestation, postpartum 1 month, 3 months, 6 months, and 12-months
Anxiety symptoms
The 20-item State Anxiety subscale of the State-Trait Anxiety Inventory (STAI) will be used to measure levels of anxiety symptoms in mothers and fathers, higher score presents more severe symptoms.
Time frame: baseline, at 36-weeks' gestation, postpartum 1 month, 3 months, 6 months, and 12-months
Heart rate variability (HRV) measures
The resting interbeat interval will be recorded
Time frame: at baseline, postpartum 1 month, 3 months, and 6 months
Infant weight
Infants' body weight in gram will be measured by trained data collectors using an electronic scale specifically for infants
Time frame: postpartum 3 months, 6 months, and 12-months
Infant height
Infants' height in cm will be measured by trained data collectors using an electronic scale specifically for infants
Time frame: postpartum 3 months, 6 months, and 12-months
Infant development
Infant's social and emotional development will be assessed using the Taiwanese version of the Ages \& Stages Questionnaires: Social-Emotional-2 (ASQ: SE-2).
Time frame: postpartum 3 months, 6 months, and 12-months
Infant feeding
Infant feeding methods will be measured using a self-report questionnaire. The feeding methods, including initiated breastfeeding within 24 hours after birth, and type of breastfeeding.
Time frame: postpartum 1 month, 3 months, and 6 months, and 12 months
Satisfaction of sleep intervention
A structured questionnaire with a 5-point Likert scale will be used to collect the level of satisfaction of the sleep intervention upon completion of programs.
Time frame: immediately after interventions
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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Taipei Medical University