Skip to main content
OpenTrials
Completed

NCT Number: NCT06143917

Efficacy of Parent-child Sleep Intervention

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Sleep Quality Behavior Dyssomnias Infant Health Mental Disorders Nervous System Diseases Personal Satisfaction Psychological Health Psychological Well-Being Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Taipei Veterans General Hospital

Taipei, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

parent-child sleep intervention

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.

Primary outcomes

  1. Change from Baseline in insomnia severity on the Chinese Version of the Insomnia Severity Index (ISI-C) at 1 month postpartum, 3 months postpartum, and 6 months postpartum

    Time frame: Baseline, 1 month postpartum, 3 months postpartum, and 6 months postpartum

    The ISI is a validated, self-reported questionnaire assessing insomnia severity over the past month period. Possible scores range from 0 (absence of insomnia) to 28 (severe insomnia).

Secondary outcomes

  1. Change from Baseline in sleep quality on the Chinese Version of the Pittsburgh sleep quality index (PSQI-C) at 1 month postpartum, 3 months postpartum, and 6 months postpartum

    Time frame: Baseline, 1 month postpartum, 3 months postpartum, and 6 months postpartum

    PSQI-C is a validated, self-reported questionnaire assessing seven sleep quality components from 0 to 3, with a total score ranging from 0 (good sleep) to 21 (very poor sleep).

  2. Change from Baseline in infant sleep quality on the Chinese Version of the Brief Infant Sleep Questionnaire-Revised Revised Short Form (BISQ-R-C SF) at 1 month postpartum, 3 months postpartum, and 6 months postpartum

    Time frame: Baseline, 1 month postpartum, 3 months postpartum, and 6 months postpartum

    BISQ-R-C SF is a validated questionnaire, the parents were instructed to refer to their child's sleep during the past week. Scores on each subscale and the total score are scaled from 0 to 100, with higher scores denoting better sleep quality, more positive perception of infant sleep, and parent behaviors that promote healthy and independent sleep.

  3. Change from Baseline in anxiety symptoms on the Chinese Version of State-Trait Anxiety Inventory (STAI-C) at 1 month postpartum, 3 months postpartum, and 6 months postpartum

    Time frame: Baseline, 1 month postpartum, 3 months postpartum, and 6 months postpartum

    STAI-C is a validated, self-reported questionnaire assessing anxiety symptoms, total scores range from 20 to 80, with higher scores denoting a high level of anxiety.

  4. Change from Baseline in parenting efficacy and satisfaction on the Chinese Version of the Parenting Sense of Competence Scale (PSOC-C) at 1 month postpartum, 3 months postpartum, and 6 months postpartum

    Time frame: Baseline, 1 month postpartum, 3 months postpartum, and 6 months postpartum

    PSOC-C is a validated, self-reported questionnaire assessing parenting self-efficacy, total scores range from 16 to 96, with higher scores denoting better perceived parental self-efficacy.

  5. Infant health outcome

    Time frame: Baseline, 1 month postpartum, 3 months postpartum, and 6 months postpartum

    Infant health outcome will be measured using a structured questionnaire, including infant height, weight and feeding methods.

  6. Satisfaction questionnaire

    Time frame: immediately after intervention

    Participants' satisfaction will be measured using a structured questionnaire.

  7. Change from Baseline in heart rate variability (HRV) at 1 month postpartum, 3 months postpartum, and 6 months postpartum

    Time frame: Baseline, 1 month postpartum, 3 months postpartum, and 6 months postpartum

    Parents' heart rate variability will be measured using the professional version of the ''Eureka Destresser'' device produced by finesse technology co. ltd. This device has been approved by the National Communications Commission (NCC) and the Federal Communication Commission (Federal Communication). Commission, FCC) certification.

  8. Activity and sleep monitor

    Time frame: Baseline, 1 month postpartum, 3 months postpartum, and 6 months postpartum

    Parents and infant sleep and daytime activity will be measured using ''ActiGraph GT9X Link'' to tracks sleep patterns, with recording 24-hour sleep diary.

Sponsors and collaborators

Lead sponsor

Taipei Veterans General Hospital, Taiwan

Other Gov

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 22, 2023
Registry last updated
Nov 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.