Clinical trial NCT06143917: Efficacy of Parent-child Sleep Intervention
Official title: Efficacy of Parent-child Sleep Intervention to Improve Sleep Quality, Psychological Health, and Infant Health in Parents of Neonates.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sleep Quality
Psychological Health
Infant Health
Keywords: Parents
Neonate
Sleep education
Sleep quality
Psychological health
Infant health
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
First posted: 2023-11-22
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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).

Primary outcomes:
measure: 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
timeFrame: Baseline, 1 month postpartum, 3 months postpartum, and 6 months postpartum
Secondary outcomes:
measure: 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
timeFrame: Baseline, 1 month postpartum, 3 months postpartum, and 6 months postpartum
measure: 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
timeFrame: Baseline, 1 month postpartum, 3 months postpartum, and 6 months postpartum
measure: 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
timeFrame: Baseline, 1 month postpartum, 3 months postpartum, and 6 months postpartum
measure: 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
timeFrame: Baseline, 1 month postpartum, 3 months postpartum, and 6 months postpartum
measure: Infant health outcome
timeFrame: Baseline, 1 month postpartum, 3 months postpartum, and 6 months postpartum
measure: Satisfaction questionnaire
timeFrame: immediately after intervention
measure: Change from Baseline in heart rate variability (HRV) at 1 month postpartum, 3 months postpartum, and 6 months postpartum
timeFrame: Baseline, 1 month postpartum, 3 months postpartum, and 6 months postpartum
measure: Activity and sleep monitor
timeFrame: Baseline, 1 month postpartum, 3 months postpartum, and 6 months postpartum
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
Study officials:
affiliation: Study Principal Investigator
name: Chien-Hui Chan
role: PRINCIPAL_INVESTIGATOR
References: