Starry-Sky Projection and Maternal Voice for Sleep After Pediatric Cardiac Surgery
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-6
SponsorShanghai Jiao Tong University School of Medicine
About this 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.
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Factorial
Treatments tested in this trial
Starry-Sky Projection
BehavioralA 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 20 minutes before anticipated sleep onset on postoperative nights 0-2.
Conventional Lighting
Other interventionParticipants will remain under routine nocturnal lighting in the CICU or general ward without additional projection.
Maternal Voice
BehavioralA 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 20 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 Voice
BehavioralA standardized recording by an unfamiliar adult woman who is not involved in the child's clinical care will be played for 20 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.
Treatment groups
172 Participants
are divided into 4 treatment groupsGroup A: Starry-Sky Projection + Maternal VoiceExperimental treatment 2 interventions
Group B: Starry-Sky Projection + Unfamiliar Female VoiceExperimental treatment 2 interventions
Group C: Conventional Lighting + Maternal VoiceActive comparator 2 interventions
Group D: Conventional Lighting + Unfamiliar Female VoiceActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Postoperative nights 0, 1, and 2Secondary outcomes
1
Total Sleep Time
Total sleep time during the nocturnal monitoring period, measured using a contactless sleep monitoring mat.
Time frame
Postoperative nights 0, 1, and 22
Sleep-Onset Latency
Time from the beginning of the nocturnal sleep monitoring period to sleep onset, measured using a contactless sleep monitoring mat.
Time frame
Postoperative nights 0, 1, and 23
Wake After Sleep Onset
Total duration of wakefulness occurring after sleep onset during the nocturnal monitoring period, measured using a contactless sleep monitoring mat.
Time frame
Postoperative nights 0, 1, and 24
Sleep Fragmentation Index
Sleep fragmentation index derived from the contactless sleep monitoring mat, reflecting the degree of sleep disruption during the nocturnal monitoring period.
Time frame
Postoperative nights 0, 1, and 2Sponsors and contacts
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Source ClinicalTrials.gov
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