NCT06143917

Efficacy of Parent-child Sleep Intervention

Efficacy of Parent-child Sleep Intervention to Improve Sleep Quality, Psychological Health, and Infant Health in Parents of Neonates.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 306 (actual)
• Sponsor: Taipei Veterans General Hospital, Taiwan · Other Government
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

Background: Parents of healthy neonates commonly face sleep disruptions and disturbances after delivery. Notably, increasing challenges are evident among parents of ill infants who required clinical care after birth . These challenges can adversely affect psychological adaptation and parental efficacy which consequently impacting the infant's development. It is crucial to develop an effective parent-child sleep intervention for improving parent-infant sleep and mental well-being and uneventful family health outcomes. Aim: To develop and evaluate the effects of parent-child sleep intervention on improving sleep quality, psychological health, and infant health in parents of infants at intermediate care nursery. Methods: A randomized controlled trial will be conducted at the intermediate care nursery of a level III medical center at Taipei city. A total of 102 pairs of parents and infants will be recruited and randomly assigned to the experimental group or the control group. The intervention program consists of (1) parent-child sleep education, (2) heart rate variability biofeedback training, and (3) counseling and support. Data collection will be multiple time points, including baseline, 1 month postpartum, 3 months postpartum, and 6 months postpartum. Anticipated results: Developing and evaluating a parent-child sleep intervention for postpartum parents and their infants. The findings will be an empirical evidence for pediatric care and family health promotion.

Detailed description

The following measures will be used, including Insomnia Severity Index, Pittsburgh Sleep Quality Index, Brief Infant Sleep Questionnaire-Revised short form, Parental Efficacy Scale, State-Trait Anxiety Inventory, Infant Health Outcome Questionnaire. Objective data included actigraphy, and heart rate variability. Data will be analyzed using descriptive statistics and One-Way repeated measure ANOVA to examine the effectiveness of the intervention.

Conditions

• Sleep Quality
• Psychological Health
• Infant Health

Interventions

Type	Name	Description
BEHAVIORAL	parent-child sleep intervention	The intervention plan is as follows: (1) Parent-child sleep education includes two in-person session and four pre-recorded online sessions. Additionally, it provides educational handbooks tailored to the course content, segmented into sections for both parents and newborns. Each session lasts approximately 20 minutes; (2) Heart rate variability measurement and Heart rate variability biofeedback are conducted in classes in person. It guides parents through breathing exercises to activate the parasympathetic nervous system, thereby easing emotions and improving psychological health; (3) Professional counseling and support are provided separately at two weeks, one month, three months, and six months postpartum.

Timeline

• Start date: 2024-02-20
• Primary completion: 2025-05-24
• Completion: 2025-05-24
• First posted: 2023-11-22
• Last updated: 2025-11-18

Locations

1 site across 1 country: Taiwan