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NCT07854145
Starry-Sky Projection and Maternal Voice for Sleep After Pediatric Cardiac Surgery
Conditions: Congenital Heart Disease (CHD), Postoperative Sleep
Sex: All
Ages: 6 Months – 6 Years
Healthy volunteers: No
Phase: NA
Enrollment: 172
Sponsor: Shanghai Jiao Tong University School of Medicine
Location: Shanghai Children's Medical Center Affiliated to Shanghai Jiao Tong University School of Medicine Shanghai Shanghai Municipality
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 Criteria
Inclusion Criteria:
* 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 Criteria:
* 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.
Source: ClinicalTrials.gov (NCT07854145). StuddyBuddy aggregates publicly available trial information.