The Development and Evaluation of Sleep Intervention for Perinatal Family

Taipei Medical University

Status: Not yet enrolling

Conditions: Perinatal Problems; Sleep; Psychological Distress

Treatments: Behavioral: Control group; Behavioral: sleep intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06487650

N202204079

Details and patient eligibility

About

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.

Full 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.

Enrollment: 600 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

600 participants in 2 patient groups

sleep intervention

Experimental group

Description:

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.

Treatment:

Behavioral: sleep intervention

Control

Active Comparator group

Description:

Participants in the control group will receive a perinatal health booklet in addition to the standardized usual care.

Treatment:

Behavioral: Control group