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

NCT07854145 | Not Yet Recruiting

• 1 other identifier: SCMCIRB-K2025331-1
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Congenital Heart Disease (CHD); Postoperative Sleep

Outcome Measures

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.

  Postoperative nights 0, 1, and 2

Secondary Outcomes (15)

• Total Sleep Time

  Postoperative nights 0, 1, and 2

• Sleep-Onset Latency

  Postoperative nights 0, 1, and 2

• Wake After Sleep Onset

  Postoperative nights 0, 1, and 2

• Sleep Fragmentation Index

  Postoperative nights 0, 1, and 2

• Sleep-Stage Distribution

  Postoperative nights 0, 1, and 2

Study Arms (4)

Starry-Sky Projection + Maternal Voice

EXPERIMENTAL

Behavioral: Starry-Sky Projection; Behavioral: Maternal Voice

Starry-Sky Projection + Unfamiliar Female Voice

EXPERIMENTAL

Behavioral: Starry-Sky Projection; Behavioral: Unfamiliar Female Voice

Conventional Lighting + Maternal Voice

ACTIVE COMPARATOR

Other: Conventional Lighting; Behavioral: Maternal Voice

Conventional Lighting + Unfamiliar Female Voice

ACTIVE COMPARATOR

Other: Conventional Lighting; Behavioral: Unfamiliar Female Voice

Interventions

Starry-Sky Projection BEHAVIORAL

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.

Starry-Sky Projection + Maternal Voice; Starry-Sky Projection + Unfamiliar Female Voice

Conventional Lighting OTHER

Participants will remain under routine nocturnal lighting in the CICU or general ward without additional projection.

Conventional Lighting + Maternal Voice; Conventional Lighting + Unfamiliar Female Voice

Maternal Voice BEHAVIORAL

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.

Conventional Lighting + Maternal Voice; Starry-Sky Projection + Maternal Voice

Unfamiliar Female Voice BEHAVIORAL

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.

Conventional Lighting + Unfamiliar Female Voice; Starry-Sky Projection + Unfamiliar Female Voice

Eligibility Criteria

• Age: 6 Months - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Shanghai Children's Medical Center Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200127, China

Location

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Biyu Shen, PhD

CONTACT

+86 13862937317; shenbiyu@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Nurse

Study Record Dates

• First Submitted: September 22, 2026
• First Posted: October 2, 2026
• Study Start (Estimated): October 8, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: October 2, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)