Congenital Heart Disease (CHD)NCT07854145
Starry-Sky Projection and Maternal Voice for Sleep After Pediatric Cardiac Surgery
A study testing Starry-Sky Projection, Conventional Lighting and Maternal Voice in people with Congenital Heart Disease (CHD) and Postoperative Sleep, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
The goal of this clinical trial is to determine whether a starry-sky projection affects sleep during the early period after cardiac surgery in young children. The main question it aims to answer is: Does a starry-sky projection improve how well children sleep during the first three nights after surgery compared with… Read more about this study
- Who is it for?
- Ages 6 months to 6 years
- Conditions the study is for
- Congenital Heart Disease (CHD), Postoperative Sleep
- What is being tested?
- Starry-Sky Projection, Conventional Lighting and Maternal Voice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2026to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 6 months to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- A confirmed diagnosis of congenital heart disease.
- Age between 6 months and 6 years.
- Scheduled to undergo their first elective open-heart surgery.
- An anticipated postoperative stay in the cardiac intensive care unit (CICU) of at least 48 hours.
- Written informed consent provided by a parent or legal guardian.
Who cannot join
- Epilepsy or another severe neurological disorder.
- A severe psychiatric disorder.
- Hearing impairment that interferes with the perception of auditory stimuli.
- Visual impairment that interferes with the perception of visual stimuli.
- Malformations of other organs or pre-existing severe comorbidities.
- A history of chronic pain.
- A previously diagnosed sleep disorder.
- Endotracheal tube could not be successfully removed before 7 p.m. on the day of surgery.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Shanghai Children's Medical Center Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200127
Biyu Shen, PhD, +86 13862937317, shenbiyu@126.com
About this study
Official title: Effects of Starry-Sky Projection and Maternal Voice on Postoperative Sleep in Children Undergoing Cardiac Surgery: A 2 × 2 Factorial Randomized Controlled Trial
The goal of this clinical trial is to determine whether a starry-sky projection affects sleep during the early period after cardiac surgery in young children. The main question it aims to answer is:
- Does a starry-sky projection improve how well children sleep during the first three nights after surgery compared with routine nighttime lighting? The study will also explore whether sleep outcomes differ between children who listen to their mother's recorded voice and those who listen to an unfamiliar woman's recorded voice, and whether the effect of the starry-sky projection differs depending on the type of voice.
Read more
Children aged 6 months to 6 years will be randomly assigned to one of four combinations of visual and sound conditions. They will:
- Receive either a starry-sky projection or routine nighttime lighting
- Listen to either their mother's recorded voice or an unfamiliar woman's recorded voice
- Have their sleep monitored during the first three nights after surgery using a contactless device placed under the pillow that does not require sensors attached to the child.
- Being tested
- Starry-Sky Projection, Conventional Lighting, Maternal Voice, Unfamiliar Female Voice
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Starry-Sky ProjectionBehavioural
A starry-sky projector will display gently moving, diffuse star-like points on the ceiling, avoiding direct light exposure to the child's eyes. Settings will remain constant, without rapid movement, frequent colour changes, or visible flicker. Built-in audio will be disabled. Sessions will last 30 minutes before anticipated sleep onset on postoperative nights 0-2.
Conventional LightingOther
Participants will remain under routine nocturnal lighting in the CICU or general ward without additional projection.
Maternal VoiceBehavioural
A personalised recording from the child's mother containing the child's name, reassuring and sleep-related phrases, and a familiar lullaby or gentle melody will be played for 30 minutes before anticipated sleep onset. The recording will be played using a speaker positioned approximately 20 cm from the child's ear, with sound intensity maintained at 45-50 dB.
Unfamiliar Female VoiceBehavioural
A standardized recording by an unfamiliar adult woman who is not involved in the child's clinical care will be played for 30 minutes before anticipated sleep onset. The recording will contain generic reassuring and sleep-related phrases and a gentle lullaby or nursery rhyme. Playback duration, speaker placement, and sound intensity will be identical to the maternal voice condition.
| Study group | Role | What they receive |
|---|---|---|
| Starry-Sky Projection + Maternal Voice | Experimental | Not described Receives: Behavioral: Starry-Sky Projection; Behavioral: Maternal Voice |
| Starry-Sky Projection + Unfamiliar Female Voice | Experimental | Not described Receives: Behavioral: Starry-Sky Projection; Behavioral: Unfamiliar Female Voice |
| Conventional Lighting + Maternal Voice | Active comparator | Not described Receives: Other: Conventional Lighting; Behavioral: Maternal Voice |
| Conventional Lighting + Unfamiliar Female Voice | Active comparator | Not described Receives: Other: Conventional Lighting; Behavioral: Unfamiliar Female Voice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep Efficiency
Sleep efficiency is defined as the percentage of total sleep time (TST) relative to time in bed (TIB) during the sleep-related nocturnal interval. TIB refers to the interval from the start of an attempt to sleep until the end of the nocturnal sleep opportunity and includes sleep onset latency and intervening wakefulness. Sleep efficiency will be assessed using a contactless ballistocardiography (BCG)-based sleep monitoring mat during postoperative nights 0-2. The mean sleep efficiency across the three postoperative nights will be used as the primary outcome measure. Higher values indicate better sleep efficiency.
Measured: Postoperative nights 0, 1, and 2
Secondary outcomes (15)
Total Sleep Time
Total sleep time during the nocturnal monitoring period, measured using a contactless sleep monitoring mat.
Measured: Postoperative nights 0, 1, and 2
Sleep-Onset Latency
Time from the beginning of the nocturnal sleep monitoring period to sleep onset, measured using a contactless sleep monitoring mat.
Measured: Postoperative nights 0, 1, and 2
Wake After Sleep Onset
Total duration of wakefulness occurring after sleep onset during the nocturnal monitoring period, measured using a contactless sleep monitoring mat.
Measured: Postoperative nights 0, 1, and 2
Sleep Fragmentation Index
Sleep fragmentation index derived from the contactless sleep monitoring mat, reflecting the degree of sleep disruption during the nocturnal monitoring period.
Measured: Postoperative nights 0, 1, and 2
Sleep-Stage Distribution
Estimated distribution of sleep stages during the nocturnal monitoring period, expressed as the proportion of total sleep time and measured using a contactless sleep monitoring mat.
Measured: Postoperative nights 0, 1, and 2
Incidence of Postoperative Delirium
Postoperative delirium will be assessed using the Cornell Assessment of Pediatric Delirium (CAPD). A total CAPD score ≥9 will indicate a positive delirium screen. Assessments will be performed every 12 hours.
Measured: Postoperative night 0 through postoperative day 2
Richmond Agitation-Sedation Scale Score
Sedation and agitation will be assessed using the Richmond Agitation-Sedation Scale (RASS). Scores range from -5 to +4, with lower scores indicating deeper sedation and higher scores indicating greater agitation. Assessments will be performed every 4 hours.
Measured: Postoperative night 0 through postoperative day 2
Pain Score
Postoperative pain will be assessed using the Face, Legs, Activity, Cry, Consolability (FLACC) scale. Scores range from 0 to 10, with higher scores indicating greater pain severity. Assessments will be performed every 4 hours.
Measured: Postoperative night 0 through postoperative day 2
Postoperative Sedative Exposure
Administration of dexmedetomidine and other sedative medications will be recorded to characterize postoperative sedative exposure.
Measured: Postoperative day 0 through postoperative day 2
Postoperative Analgesic Exposure
Administration of sufentanil and other analgesic medications will be recorded to characterize postoperative analgesic exposure.
Measured: Postoperative day 0 through postoperative day 2
Postoperative Vasoactive Medication Exposure
Administration of dopamine and other vasoactive medications will be recorded to characterize postoperative vasoactive medication exposure.
Measured: Postoperative day 0 through postoperative day 2
Heart Rate Variability
Heart rate variability will be continuously measured using the 5S Sleep Tracking Mat as an objective indicator of autonomic regulation.
Measured: Postoperative nights 0, 1, and 2
CICU Length of Stay
Cardiac intensive care unit (CICU) length of stay will be calculated from postoperative CICU admission to CICU discharge.
Measured: Measured in days admitted to the CICU, an average of 2 days
Total Hospital Length of Stay
Total hospital length of stay will be calculated as the number of days from hospital admission to hospital discharge.
Measured: Measured in days admitted to the hospital, an average of 10 days.
Parental satisfaction
Parental satisfaction with the child's overall hospital care will be assessed using a 100-mm visual analogue scale (VAS), ranging from 0 mm ("very dissatisfied") to 100 mm ("very satisfied"). Higher scores indicate greater satisfaction.
Measured: On the day of discharge, an average of 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart Disease (CHD)Studies of the same condition, open and under way.
- More trials run by Shanghai Jiao Tong University School of MedicineThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 172 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Biyu Shen, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07854145
- Sponsor's protocol ID
- SCMCIRB-K2025331-1
- Status last verified
- Oct 2026
- First submitted
- 22 Sep 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Starry-Sky Projection and Maternal Voice on Postoperative Sleep in Children Undergoing Cardiac Surgery: A 2 × 2 Factorial Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07854145
- Acronym / sponsor ID
- SCMCIRB-K2025331-1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 172 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 2 Oct 2026 (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.
The goal of this clinical trial is to determine whether a starry-sky projection affects sleep during the early period after cardiac surgery in young children. The main question it aims to answer is:
- Does a starry-sky projection improve how well children sleep during the first three nights after surgery compared with routine nighttime lighting? The study will also explore whether sleep outcomes differ between children who listen to their mother's recorded voice and those who listen to an unfamiliar woman's recorded voice, and whether the effect of the starry-sky projection differs depending on the type of voice.
Children aged 6 months to 6 years will be randomly assigned to one of four combinations of visual and sound conditions. They will:
- Receive either a starry-sky projection or routine nighttime lighting
- Listen to either their mother's recorded voice or an unfamiliar woman's recorded voice
- Have their sleep monitored during the first three nights after surgery using a contactless device placed under the pillow that does not require sensors attached to the child.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Starry-Sky Projection + Maternal Voice | Experimental | Behavioral: Starry-Sky Projection, Behavioral: Maternal Voice |
| Starry-Sky Projection + Unfamiliar Female Voice | Experimental | Behavioral: Starry-Sky Projection, Behavioral: Unfamiliar Female Voice |
| Conventional Lighting + Maternal Voice | Active comparator | Other: Conventional Lighting, Behavioral: Maternal Voice |
| Conventional Lighting + Unfamiliar Female Voice | Active comparator | Other: Conventional Lighting, Behavioral: Unfamiliar Female Voice |
Who may qualify
- Ages
- 6 months to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- A confirmed diagnosis of congenital heart disease.
- Age between 6 months and 6 years.
- Scheduled to undergo their first elective open-heart surgery.
- An anticipated postoperative stay in the cardiac intensive care unit (CICU) of at least 48 hours.
- Written informed consent provided by a parent or legal guardian.
Key exclusion criteria (8 listed)
- Epilepsy or another severe neurological disorder.
- A severe psychiatric disorder.
- Hearing impairment that interferes with the perception of auditory stimuli.
- Visual impairment that interferes with the perception of visual stimuli.
- Malformations of other organs or pre-existing severe comorbidities.
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 |
|---|---|---|
| Starry-Sky ProjectionA starry-sky projector will display gently moving, diffuse star-like points on the ceiling, avoiding direct light exposure to the child's eyes. Settings will remain constant, without rapid movement, frequent colour changes, or visible flicker. Built-in audio will be disabled. Sessions will last 30 minutes before anticipated sleep onset on postoperative nights 0-2. | Behavioural | Starry-Sky Projection + Maternal Voice, Starry-Sky Projection + Unfamiliar Female Voice |
| Conventional LightingParticipants will remain under routine nocturnal lighting in the CICU or general ward without additional projection. | Other | Conventional Lighting + Maternal Voice, Conventional Lighting + Unfamiliar Female Voice |
| Maternal VoiceA personalised recording from the child's mother containing the child's name, reassuring and sleep-related phrases, and a familiar lullaby or gentle melody will be played for 30 minutes before anticipated sleep onset. The recording will be played using a speaker positioned approximately 20 cm from the child's ear, with sound intensity maintained at 45-50 dB. | Behavioural | Conventional Lighting + Maternal Voice, Starry-Sky Projection + Maternal Voice |
| Unfamiliar Female VoiceA standardized recording by an unfamiliar adult woman who is not involved in the child's clinical care will be played for 30 minutes before anticipated sleep onset. The recording will contain generic reassuring and sleep-related phrases and a gentle lullaby or nursery rhyme. Playback duration, speaker placement, and sound intensity will be identical to the maternal voice condition. | Behavioural | Conventional Lighting + Unfamiliar Female Voice, Starry-Sky Projection + Unfamiliar Female Voice |
Primary outcome
Sleep Efficiency
Time frame: Postoperative nights 0, 1, and 2
Sleep efficiency is defined as the percentage of total sleep time (TST) relative to time in bed (TIB) during the sleep-related nocturnal interval. TIB refers to the interval from the start of an attempt to sleep until the end of the nocturnal sleep opportunity and includes sleep onset latency and intervening wakefulness. Sleep efficiency will be assessed using a contactless ballistocardiography (BCG)-based sleep monitoring mat during postoperative nights 0-2. The mean sleep efficiency across the three postoperative nights will be used as the primary outcome measure. Higher values indicate better sleep efficiency.
15 secondary outcomes
Total Sleep Time
Time frame: Postoperative nights 0, 1, and 2
Sleep-Onset Latency
Time frame: Postoperative nights 0, 1, and 2
Wake After Sleep Onset
Time frame: Postoperative nights 0, 1, and 2
Sleep Fragmentation Index
Time frame: Postoperative nights 0, 1, and 2
Sleep-Stage Distribution
Time frame: Postoperative nights 0, 1, and 2
Incidence of Postoperative Delirium
Time frame: Postoperative night 0 through postoperative day 2
Richmond Agitation-Sedation Scale Score
Time frame: Postoperative night 0 through postoperative day 2
Pain Score
Time frame: Postoperative night 0 through postoperative day 2
Postoperative Sedative Exposure
Time frame: Postoperative day 0 through postoperative day 2
Postoperative Analgesic Exposure
Time frame: Postoperative day 0 through postoperative day 2
Postoperative Vasoactive Medication Exposure
Time frame: Postoperative day 0 through postoperative day 2
Heart Rate Variability
Time frame: Postoperative nights 0, 1, and 2
CICU Length of Stay
Time frame: Measured in days admitted to the CICU, an average of 2 days
Total Hospital Length of Stay
Time frame: Measured in days admitted to the hospital, an average of 10 days.
Parental satisfaction
Time frame: On the day of discharge, an average of 10 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Starry-Sky Projection, Conventional Lighting and Maternal Voice in people with Congenital Heart Disease (CHD) and Postoperative Sleep, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
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 5 inclusion and 8 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: opening soon, as of the sponsor's last update on 30 Oct 2026. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Biyu Shen, PhD (+86 13862937317, shenbiyu@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep Efficiency (time frame: Postoperative nights 0, 1, and 2). 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 30 Oct 2026.