Efficacy of Parent-child Sleep Intervention

NCT ID: NCT06143917

Last Updated: 2025-11-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 306 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-20
• Study Completion Date: 2025-05-24

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

parent-child sleep intervention

Participants in the intervention will receive both the standardized usual care and parent-child sleep education, heart rate variability biofeedback training, and counseling and support.

Group Type: EXPERIMENTAL

parent-child sleep intervention

Intervention Type: BEHAVIORAL

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.

Control

Participants in the control group will receive attention from the research nurse and the standardized usual care.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Postpartum women aged 18 years or older.
• Postpartum women with a singleton pregnancy, and the gestational age of their infant is at least 32 weeks.
• Postpartum women with a severe insomnia severity index score of ≥8 points.
• Postpartum women and their husbands or partners capable of reading, understanding, and communicating in Mandarin.
• Postpartum women and their husbands or partners with internet access and the ability to operate resources using a smartphone, tablet, or computer.
• Both postpartum women and their husbands or partners are willing to participate in the research process.

Exclusion Criteria

• Postpartum women diagnosed with Insomnia Disorder, Anxiety Disorders, or Depression.
• Postpartum women suffering from arrhythmia or cardiovascular diseases.
• Postpartum women working in shifts.
• Infants with congenital abnormalities, neurological impairments (such as hydrocephalus, periventricular leukomalacia), requiring the use of tubes or respirators after discharge, or using medications that might affect sleep (such as caffeine, sedatives, muscle relaxant, anti-epileptic drugs, or pain medications).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Taipei Veterans General Hospital, Taiwan

OTHER_GOV

Sponsor Role: lead

Responsible Party

VGHuser_Chien-Hui Chan

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chien-Hui Chan

Role: PRINCIPAL_INVESTIGATOR

Study Principal Investigator

Locations

Taipei Veterans General Hospital

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

2023-10-012C

Identifier Type: -

Identifier Source: org_study_id