Sleep QualityNCT06143917
Efficacy of Parent-child Sleep Intervention
A study testing parent-child sleep intervention in people with Sleep Quality and Psychological Health, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
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 . Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Quality, Psychological Health, Infant Health
- What is being tested?
- parent-child sleep intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 306 participants
- Where
- 1 siteTaiwan
- Study dates
- 20 Feb 2024to 24 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Parent-child Sleep Intervention to Improve Sleep Quality, Psychological Health, and Infant Health in Parents of Neonates.
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.
Read more
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.
Read the 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
- Being tested
- parent-child sleep intervention
- Keywords
- Parents, Neonate, Sleep education, Sleep quality, Psychological health, Infant health
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
parent-child sleep interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| parent-child sleep intervention | Experimental | 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. Receives: Behavioral: parent-child sleep intervention |
| Control | No intervention | Participants in the control group will receive attention from the research nurse and the standardized usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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).
Measured: Baseline, 1 month postpartum, 3 months postpartum, and 6 months postpartum
Secondary outcomes (8)
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
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).
Measured: Baseline, 1 month postpartum, 3 months postpartum, and 6 months postpartum
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
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.
Measured: Baseline, 1 month postpartum, 3 months postpartum, and 6 months postpartum
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
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.
Measured: Baseline, 1 month postpartum, 3 months postpartum, and 6 months postpartum
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
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.
Measured: Baseline, 1 month postpartum, 3 months postpartum, and 6 months postpartum
Infant health outcome
Infant health outcome will be measured using a structured questionnaire, including infant height, weight and feeding methods.
Measured: Baseline, 1 month postpartum, 3 months postpartum, and 6 months postpartum
Satisfaction questionnaire
Participants' satisfaction will be measured using a structured questionnaire.
Measured: immediately after intervention
Change from Baseline in heart rate variability (HRV) at 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.
Measured: Baseline, 1 month postpartum, 3 months postpartum, and 6 months postpartum
Activity and sleep monitor
Parents and infant sleep and daytime activity will be measured using ''ActiGraph GT9X Link'' to tracks sleep patterns, with recording 24-hour sleep diary.
Measured: Baseline, 1 month postpartum, 3 months postpartum, and 6 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2023
- Study start20 Feb 2024
- Primary completion24 May 2025
- Study completion24 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep QualityStudies of the same condition, open and under way.
- More trials run by Taipei Veterans General Hospital, TaiwanThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 306 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Responsible party
- Principal investigator, VGHuser_Chien-Hui Chan, Taipei Veterans General Hospital, Taiwan
- Investigators
- Chien-Hui Chan, Principal investigator, Study Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06143917
- Sponsor's protocol ID
- 2023-10-012C
- Status last verified
- Nov 2025
- First submitted
- 16 Nov 2023
- Last updated
- 18 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Parent-child Sleep Intervention to Improve Sleep Quality, Psychological Health, and Infant Health in Parents of Neonates.
- ClinicalTrials.gov ID
- NCT06143917
- Acronym / sponsor ID
- 2023-10-012C
- Conditions
- Sleep Quality, Psychological Health, Infant Health
- Keywords
- Parents, Neonate, Sleep education, Sleep quality, Psychological health, Infant health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 306 participants (actual)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- 20 Feb 2024 (actual)
- Primary completion
- 24 May 2025 (actual)
- Study completion
- 24 May 2025 (actual)
- First posted
- 22 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| parent-child sleep intervention | Experimental | Behavioral: parent-child sleep interventionParticipants in the intervention will receive both the standardized usual care and parent-child sleep education, heart rate variability biofeedback training, and counseling and support. |
| Control | No intervention | –Participants in the control group will receive attention from the research nurse and the standardized usual care. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| parent-child sleep interventionThe 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. | Behavioural | parent-child sleep intervention |
Primary outcome
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).
8 secondary outcomes
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
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
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
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
Infant health outcome
Time frame: Baseline, 1 month postpartum, 3 months postpartum, and 6 months postpartum
Satisfaction questionnaire
Time frame: immediately after intervention
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
Activity and sleep monitor
Time frame: Baseline, 1 month postpartum, 3 months postpartum, and 6 months postpartum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chien-Hui Chan principal investigator
Study Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing parent-child sleep intervention in people with Sleep Quality and Psychological Health, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: Baseline, 1 month postpartum, 3 months postpartum, and 6 months postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2025.