Starry-Sky Projection and Maternal Voice for Sleep After Pediatric Cardiac Surgery

Condition(s) studied

Investigational drug(s) / intervention(s)

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 30 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 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 Voice: 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 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.

Eligibility

Primary outcome measure(s)

• Sleep Efficiency — 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.

Trial sites (1)

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