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Effect of the use of mothers’ voices on the quality of sleep in children after cardiac surgery : protocol for a randomised controlled trial

Study on the effect of circadian rhythm-based sound intervention on sleep quality in children after congenital heart disease

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500111004
Enrollment
Unknown
Registered
2025-10-23
Start date
2025-11-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital heart disease

Interventions

The mothers’ voices group:mothers’ voices

Sponsors

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

Eligibility

Sex/Gender
All
Age
No minimum to 6 Years

Inclusion criteria

Inclusion criteria: Diagnosed with CHD; Between the ages of 6 months and 6 years; Received open-heart surgery; Informed consent provided by Parents.

Exclusion criteria

Exclusion criteria: Needed to return to the operating room; Received extracorporeal membrane oxygenation (ECMO) therapy; Heart transplantation; History of epilepsy; History of chronic pain; Combined with hearing problems; Combined with other organ malformations or other serious complications; Prolonged intubation (>6 hours) following cardiac surgery.

Design outcomes

Primary

MeasureTime frame
sleep efficiency;

Secondary

MeasureTime frame
sleep latency;total sleep time;wake time during sleep;number of wakes during sleep;pain scores;delirium scores;sedation Score;dose of dexmedetomidine;CICU length of stay;total hospital stay;parental satisfaction;

Countries

China

Contacts

Public ContactShi Songsong

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

ntsss1988@126.com+86 159 9658 8254

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026