Starry-Sky Projection and Maternal Voice for Sleep After Pediatric Cardiac Surgery
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- Who runs it
- Shanghai Jiao Tong University School of Medicine
- Trial code
- NCT07854145
- Record updated
- 30 October 2026
- Original description
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:Read full original descriptionShow less
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.
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.
Inclusion: 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.
Exclusion: A previously diagnosed sleep disorder; Endotracheal tube could not be successfully removed before 7 p.m. on the day of surgery; 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; A history of chronic pain; Malformations of other organs or pre-existing severe comorbidities.