UnknownNot Applicable

A Study on Noise Exposure Status and the Effect of Noise Management in Pediatric Intensive Care Unit

China204 participantsStarted 2020-07-16

Plain-language summary

This study has two stages. At the first stage,the investigators will try to use noise detectors to investigate the status of noise exposure in the pediatric intensive care unit(PICU) and to analyze the main noise sources in it. At the second stage,the investigators will try to evaluate the effect of noise management on noise exposure and health outcomes of the pediatric patients in PICU.The investigators hypothesize that noise exposure in PICU is higher than the standard.The investigators also hypothesize that the implementation of the noise management will improve the noise exposure and health outcomes of the pediatric patients in PICU.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients aged ≤ 18 years * The predicted PICU LOS ≥12 hours * The informed consent of the child's guardian was obtained Exclusion Criteria: * Patients with delirium on admission * Patients in a coma (Richmond Agitation Sedation Scale\[RASS\]-4 or -5) all through their stay in PICU * Patients with mental disorders or mental retardation, who continue to use antipsychotic drugs * Patients undergoing neurosurgery and neurology surgery * Hearing or visual impairment * Non Chinese or English language users * Missed or incomplete delirium score

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Noise exposure

Timeframe: Average of 1 weak

Delirium incidence

Timeframe: Up to 1 month

Trial details

NCT IDNCT04544085

SponsorXinhua Hospital, Shanghai Jiao Tong University School of Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-11

Contact for this trial

Xiaohua Ge

+86-18616706778 gexiaohua@shsmu.edu.cn

View on ClinicalTrials.gov More Noise Exposure trials