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Starry-Sky Projection and Maternal Voice for Sleep After Pediatric Cardiac Surgery
Sponsor: Shanghai Jiao Tong University School of Medicine
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 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.
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
Key Details
Gender
All
Age Range
6 Months - 6 Years
Study Type
INTERVENTIONAL
Enrollment
172
Start Date
2026-10-08
Completion Date
2026-12-31
Last Updated
2026-10-02
Healthy Volunteers
No
Interventions
Starry-Sky Projection
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 20 minutes before anticipated sleep onset on postoperative nights 0-2.
Conventional Lighting
Participants will remain under routine nocturnal lighting in the CICU or general ward without additional projection.
Maternal Voice
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 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
A 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.
Locations (1)
Shanghai Children's Medical Center Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China