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A Prospective Longitudinal Mixed Study on the Change Track of Sleep Quality in Critically Ill Children

Sleep Quality of Critically Ill Children Change Trajectory and Prediction Factors: A Prospective Longitudinal Mixed Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05863299
Enrollment
247
Registered
2023-05-18
Start date
2022-11-17
Completion date
2023-12-31
Last updated
2024-02-07

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

Conditions

Child, Critical Illness, Sleep Disorder

Brief summary

This research adopts the uniform parallel hybrid research design; The quantitative data and qualitative data were collected at the same time, and then the quantitative and qualitative data were analyzed respectively. Finally, the two data sets were combined. Comprehensive interpretation of the study issues through complementarity and mutual validation of quantitative and qualitative data.

Detailed description

With the progress and development of medical technology, the mortality rate of critically ill children continues to decline. To improve the long-term prognosis of children has become a new goal of modern medicine. Sleep disorders in critically ill children are caused by disease factors, the complex environment of ICU, and various treatment factors, which have seriously affected the patient's rehabilitation and long-term quality of life. Attention should be paid to the sleep disorders in critically ill children. At present, the research on sleep disorders in critically ill patients in China is mostly focused on adults, and the critically ill children are rarely involved, and there is no research related to sleep disorders and recovery tracks of critically ill children. This prospective longitudinal mixed study aims to describe the change trajectory of sleep disorder and recovery in critically ill children and provide suggestions for subsequent clinical workers to formulate reasonable intervention measures.

Interventions

None listed

Sponsors

Children's Hospital of Fudan University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
2 Years to 16 Years
Healthy volunteers
No

Inclusion criteria

① Age 3-12 years; * Children who are conscious during ICU, * children with Glasgow score of 15

Exclusion criteria

* (1) did not meet the discharge standards, and asked to be discharged; * Children with sleep disorder before admission to PICU, that is, those with baseline CSHQ score \> 41; * The child had a history of mental illness and cognitive impairment. * Children with brain injury, coma, disturbance of consciousness, epilepsy and status epilepticus, obstructive sleep apnea hypopnea syndrome; ⑤ Children with hearing and hearing impairment ⑥ICU stay \> 30 days.

Design outcomes

Primary

MeasureTime frameDescription
Mean Total Night Sleep Minutes2023.12.31Mean Total Night Sleep Minutes
Deep sleep time2023.12.31Deep sleep time
Children sleep habit questionnaire score2023.12.31Children sleep habit questionnaire score

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026