Efficacy of Parent-child Sleep Intervention to Improve Sleep Quality,

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06143917
Study type	Interventional
Source	Taipei Veterans General Hospital, Taiwan
Contact	Chien-Hui Chan
Phone	+886 978579717
Email	g462110018@tmu.edu.tw
Status	Not yet recruiting
Phase	N/A
Start date	January 2024
Completion date	September 2024

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms