The Development and Evaluation of Sleep Intervention for Perinatal Family

Not Applicable

Not yet recruiting

• Conditions: Sleep; Psychological Distress; Perinatal Problems
• Interventions: Behavioral: sleep intervention; Behavioral: Control group

• Registration Number: NCT06487650
• Lead Sponsor: Taipei Medical University

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.

Study Timeline

• Study First Submitted: 2024-06-13
• Study First Submitted QC: 2024-06-27
• Study First Posted: 2024-07-05
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-12
• Last Update Posted: 2025-01-14
• Study Start: 2025-12
• Primary Completion: 2026-09
• Study Completion: 2026-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 600

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sleep intervention	sleep intervention	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.
Control	Control group	Participants in the control group will receive a perinatal health booklet in addition to the standardized usual care.

Primary Outcome Measures

Name	Time	Method
Insomnia Severity Index	baseline, at 36-weeks' gestation, 2-week postpartum, 1-month, 3-month,6-month, and 12-month postpartum	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.

Secondary Outcome Measures

Name	Time	Method
Sleep efficacy using actigraphy	baseline, postpartum 1 month, 3 months, and 6 months.	The Actiwatch will be used to collect objective data of sleep efficacy
Infants sleep Questionnaire	postpartum 1 month, 3 months, 6 months, and 12-months	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
Heart rate variability (HRV) measures	at baseline, postpartum 1 month, 3 months, and 6 months	The resting interbeat interval will be recorded
Sleep duration using actigraphy	baseline, postpartum 1 month, 3 months, and 6 months.	The Actiwatch will be used to collect objective data of sleep duration
Wake after sleep onset using actigraphy	baseline, postpartum 1 month, 3 months, and 6 months.	The Actiwatch will be used to collect objective data of wake after sleep onset
Infant height	postpartum 3 months, 6 months, and 12-months	Infants' height in cm will be measured by trained data collectors using an electronic scale specifically for infants
Satisfaction of sleep intervention	immediately after interventions	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.
Sleep sleep onset latency using actigraphy	baseline, postpartum 1 month, 3 months, and 6 months.	The Actiwatch will be used to collect objective data of sleep onset latency
Sleep quality	baseline, at 36-weeks' gestation, postpartum 1 month, 3 months, 6 months, and 12-months	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
Depressive symptoms	baseline, at 36-weeks' gestation, postpartum 1 month, 3 months, 6 months, and 12-months	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.
Anxiety symptoms	baseline, at 36-weeks' gestation, postpartum 1 month, 3 months, 6 months, and 12-months	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.
Infant feeding	postpartum 1 month, 3 months, and 6 months, and 12 months	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.
Infant weight	postpartum 3 months, 6 months, and 12-months	Infants' body weight in gram will be measured by trained data collectors using an electronic scale specifically for infants
Infant development	postpartum 3 months, 6 months, and 12-months	Infant's social and emotional development will be assessed using the Taiwanese version of the Ages \& Stages Questionnaires: Social-Emotional-2 (ASQ: SE-2).