The Development and Evaluation of Sleep Intervention for Perinatal Family

NCT06487650 | Not Yet Recruiting

• 1 other identifier: N202204079
• Study Type: interventional
• Target: 600
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Sleep; Psychological Distress; Perinatal Problems

Keywords

sleep quality; perinatal; depression; anxiety; infant sleep; infant health

Outcome Measures

Primary Outcomes (1)

• 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.

  baseline, at 36-weeks' gestation, 2-week postpartum, 1-month, 3-month,6-month, and 12-month postpartum

Secondary Outcomes (14)

• Sleep quality

  baseline, at 36-weeks' gestation, postpartum 1 month, 3 months, 6 months, and 12-months

• Sleep duration using actigraphy

  baseline, postpartum 1 month, 3 months, and 6 months.

• Sleep sleep onset latency using actigraphy

  baseline, postpartum 1 month, 3 months, and 6 months.

• Sleep efficacy using actigraphy

  baseline, postpartum 1 month, 3 months, and 6 months.

• Wake after sleep onset using actigraphy

  baseline, postpartum 1 month, 3 months, and 6 months.

Study Arms (2)

sleep intervention

EXPERIMENTAL

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

Control

ACTIVE COMPARATOR

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

Behavioral: Control group

Interventions

sleep intervention BEHAVIORAL

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.

sleep intervention

Control group BEHAVIORAL

Participants in control group will follow standardized usual care and a perinatal health booklet

Control

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Taipei Medical University: lead

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Depression; Anxiety Disorders

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Shu-Yu Kuo, Phd

  Taipei Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shu-Yu Kuo

CONTACT

+886-2-2736-1661; sykuo@tmu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2024
• First Posted: July 5, 2024
• Study Start: December 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: January 14, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share