Noise ExposureNCT04544085
A Study on Noise Exposure Status and the Effect of Noise Management in Pediatric Intensive Care Unit
A study testing noise management in people with Noise Exposure and Delirium, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Noise Exposure, Delirium
- What is being tested?
- noise management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- 1 siteChina
- Study dates
- 16 Jul 2020to Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients aged ≤ 18 years
- The predicted PICU LOS ≥12 hours
- The informed consent of the child's guardian was obtained
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xinhua Hospital Affiliated To Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200092
Xiaohua Ge, +86-21-25076124, gexiaohua@shsmu.edu.cn
About this study
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.
Read the detailed description
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.
1.For the investigation of the status of noise exposure:
(1) Preparation of noise monitor equipment: select noise detectors conforming to the national standard. All noise detectors used in the study are of the same brand; (2) Use of noise monitor: set the mode of noise monitor according to the national standard: place the monitor in accordance with the requirements;(3) All the data of noise exposure will be collected and sorted out by the investigator. (4) Spss20.0 software is used for descriptive analysis and statistical inference. Mean ± standard deviation, median and quartile are used to describe measurement data, while frequency and percentage are used to describe counting data. Comparison between groups: when the measurement data obey normal distribution and the variance is homogeneous, two independent sample t-test are used to compare whether there is statistical difference between the two groups of indicators or index difference (measured value baseline value); if it does not obey normal distribution or the variance is uneven, non parametric statistical method is used; counting data: Chi square test is used to compare whether there is statistical difference between the two groups of index values, test level: α = 0.05 2.For the evaluation of the effect of noise management on noise exposure and health outcomes of the pediatric patients in PICU:
(1)General information and clinical data of patients will be collected through hospital electronic information system, ICU nursing records, cases, doctor's advice and consultation. The investigator will evaluate and record the delirium score of ICU children who met the inclusion criteria each shift . At the time of discharge, PICU duration, hospital stay, MV duration and in-hospital mortality were inquired by EMR. (2) Quality control of intervention implementation are as follows:① According to the research results of early promotion strategy, relevant training materials were made to carry out training and education for PICU medical staff;② During the implementation of the intervention, irregular sampling of medical staff was conducted to evaluate the implementation of the intervention and give timely feedback.(3) Collection of information:① The data of patients will be collected by the investigator;② Pediatric delirium score: in order to ensure the quality of the study, the investigator will conduct random sampling and assess the delirium of children in the same patient with the nurses from time to time to investigate the evaluation quality;③ Input the data into EpiData, set reasonable numerical boundary value and logical check items. If there is logical error, check the original data for correction, and import the data into spss20.0 for statistical analysis.
(4) Sample size assessment: the assessment of sample size in experimental research can also be divided into measurement data and counting data. The main outcome measures are delirium rate and noise exposure. Therefore, the incidence of delirium will be used as the rate to calculate the sample size.According to the calculation formula of the rate: n = (U α + U β) 22P (1-p) / (P1-P2) 2, the sample size of the control group and the intervention group are calculated. Uα=1.64,Uβ=0.84。P1 and P2 are the estimated values of delirium incidence before and after the intervention, and P is the total rate. The references showed that P1 = 33%, P2 = 14%.The sample size calculated by the formula is: (1.64 + 0.84) 2 * 2 * 0.47 * 0.53 / 0.192 = 85 cases, plus 20% of the sample loss, that is, 102 cases in the control group and 102 cases in the intervention group (5)Statistical Analysis:①Data set: use EpiData 3.1 software to establish the data set, and clean up and check the data;② The data will be imported into spss20.0 for statistical analysis. Descriptive analysis and statistical inference will be carried out. Mean ± standard deviation, median and quartile are used to describe measurement data, while frequency and percentage are used to describe counting data. Comparison between groups: when the measurement data obeys normal distribution and the variance is homogeneous, two independent sample t-test is used to compare whether there is statistical difference in the indicators or index difference (measured value baseline value) between the two groups; if the measurement data does not obey the normal distribution or the variance is uneven, non parametric statistical method is used; counting data: Chi square test is used to compare whether there is statistical difference between the two groups of patients Level: α = 0.05.
- Conditions
- Noise Exposure, Delirium
- Being tested
- noise management
- Keywords
- Noise Exposure, Delirium, pediatric, intensive care
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
noise managementBehavioural
The intervention mainly includes the following three parts: control of noise source, control of noise transmission and personal protection of noise receiver.(1) control of noise source:equipment maintenance,alarm management,set quiet time,etc.;(2)control of noise transmission:improvement of architectural design;(3)personal protection of noise receiver:providing patients with earmuffs or earplugs.
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | Patients in the control group will not receive any noise management intervention |
| experimental group | Experimental | Patients in the experimental group will receive noise management. The intervention measures mainly include the following three parts: control of noise source, control of noise transmission and personal protection of noise receiver.We will strengthen the education of medical staff to ensure the effective implementation of the noise management. Receives: Behavioral: noise management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Noise exposure
Noise is measured in decibels.The noise exposure in PICU will be described in Leq,Lmax,Lmin
Measured: Average of 1 weak
Delirium incidence
Delirium screening is performed using the Cornell assessment of pediatric delirium(CAPD).Delirium will be screened every 12 hours(at 8:00a.m.\&20:00p.m.) until the patient is transferred out of PICU or drops out
Measured: Up to 1 month
Secondary outcomes (4)
PICU length of stay(LOS)
PICU LOS is measured in days
Measured: 60 days after the enrollment
Duration of mechanical ventilation(MV)
Duration of MV is measured in days
Measured: 60 days after the enrollment
Hospital length of stay(LOS)
Hospital LOS is measured in days
Measured: 60 days after the enrollment
Medical staff's knowledge of noise management
Medical staff's knowledge of noise management is evaluated by a self-made questionnaire
Measured: 1 hour within the end of the lecture on noise management for medical staff
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2020
- Study start16 Jul 2020
- Primary completionNov 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Noise ExposureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 204 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiaohua Ge, Principal investigator, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04544085
- Sponsor's protocol ID
- XH-20-016
- Status last verified
- Aug 2020
- First submitted
- 26 Aug 2020
- Last updated
- 10 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on Noise Exposure Status and the Effect of Noise Management in Pediatric Intensive Care Unit
- ClinicalTrials.gov ID
- NCT04544085
- Acronym / sponsor ID
- XH-20-016
- Conditions
- Noise Exposure, Delirium
- Keywords
- Noise Exposure, Delirium, pediatric, intensive care
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 204 participants (estimated)
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 16 Jul 2020 (actual)
- Primary completion
- Nov 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 10 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
1.For the investigation of the status of noise exposure:
(1) Preparation of noise monitor equipment: select noise detectors conforming to the national standard. All noise detectors used in the study are of the same brand; (2) Use of noise monitor: set the mode of noise monitor according to the national standard: place the monitor in accordance with the requirements;(3) All the data of noise exposure will be collected and sorted out by the investigator. (4) Spss20.0 software is used for descriptive analysis and statistical inference. Mean ± standard deviation, median and quartile are used to describe measurement data, while frequency and percentage are used to describe counting data. Comparison between groups: when the measurement data obey normal distribution and the variance is homogeneous, two independent sample t-test are used to compare whether there is statistical difference between the two groups of indicators or index difference (measured value baseline value); if it does not obey normal distribution or the variance is uneven, non parametric statistical method is used; counting data: Chi square test is used to compare whether there is statistical difference between the two groups of index values, test level: α = 0.05 2.For the evaluation of the effect of noise management on noise exposure and health outcomes of the pediatric patients in PICU:
(1)General information and clinical data of patients will be collected through hospital electronic information system, ICU nursing records, cases, doctor's advice and consultation. The investigator will evaluate and record the delirium score of ICU children who met the inclusion criteria each shift . At the time of discharge, PICU duration, hospital stay, MV duration and in-hospital mortality were inquired by EMR. (2) Quality control of intervention implementation are as follows:① According to the research results of early promotion strategy, relevant training materials were made to carry out training and education for PICU medical staff;② During the implementation of the intervention, irregular sampling of medical staff was conducted to evaluate the implementation of the intervention and give timely feedback.(3) Collection of information:① The data of patients will be collected by the investigator;② Pediatric delirium score: in order to ensure the quality of the study, the investigator will conduct random sampling and assess the delirium of children in the same patient with the nurses from time to time to investigate the evaluation quality;③ Input the data into EpiData, set reasonable numerical boundary value and logical check items. If there is logical error, check the original data for correction, and import the data into spss20.0 for statistical analysis.
(4) Sample size assessment: the assessment of sample size in experimental research can also be divided into measurement data and counting data. The main outcome measures are delirium rate and noise exposure. Therefore, the incidence of delirium will be used as the rate to calculate the sample size.According to the calculation formula of the rate: n = (U α + U β) 22P (1-p) / (P1-P2) 2, the sample size of the control group and the intervention group are calculated. Uα=1.64,Uβ=0.84。P1 and P2 are the estimated values of delirium incidence before and after the intervention, and P is the total rate. The references showed that P1 = 33%, P2 = 14%.The sample size calculated by the formula is: (1.64 + 0.84) 2 * 2 * 0.47 * 0.53 / 0.192 = 85 cases, plus 20% of the sample loss, that is, 102 cases in the control group and 102 cases in the intervention group (5)Statistical Analysis:①Data set: use EpiData 3.1 software to establish the data set, and clean up and check the data;② The data will be imported into spss20.0 for statistical analysis. Descriptive analysis and statistical inference will be carried out. Mean ± standard deviation, median and quartile are used to describe measurement data, while frequency and percentage are used to describe counting data. Comparison between groups: when the measurement data obeys normal distribution and the variance is homogeneous, two independent sample t-test is used to compare whether there is statistical difference in the indicators or index difference (measured value baseline value) between the two groups; if the measurement data does not obey the normal distribution or the variance is uneven, non parametric statistical method is used; counting data: Chi square test is used to compare whether there is statistical difference between the two groups of patients Level: α = 0.05.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –Patients in the control group will not receive any noise management intervention |
| experimental group | Experimental | Behavioral: noise managementPatients in the experimental group will receive noise management. The intervention measures mainly include the following three parts: control of noise source, control of noise transmission and personal protection of noise receiver.We will strengthen the education of medical staff to ensure the effective implementation of the noise management. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Patients aged ≤ 18 years
- The predicted PICU LOS ≥12 hours
- The informed consent of the child's guardian was obtained
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| noise managementThe intervention mainly includes the following three parts: control of noise source, control of noise transmission and personal protection of noise receiver.(1) control of noise source:equipment maintenance,alarm management,set quiet time,etc.;(2)control of noise transmission:improvement of architectural design;(3)personal protection of noise receiver:providing patients with earmuffs or earplugs. | Behavioural | experimental group |
Primary outcome
Noise exposure
Time frame: Average of 1 weak
Noise is measured in decibels.The noise exposure in PICU will be described in Leq,Lmax,Lmin
Delirium incidence
Time frame: Up to 1 month
Delirium screening is performed using the Cornell assessment of pediatric delirium(CAPD).Delirium will be screened every 12 hours(at 8:00a.m.\&20:00p.m.) until the patient is transferred out of PICU or drops out
4 secondary outcomes
PICU length of stay(LOS)
Time frame: 60 days after the enrollment
Duration of mechanical ventilation(MV)
Time frame: 60 days after the enrollment
Hospital length of stay(LOS)
Time frame: 60 days after the enrollment
Medical staff's knowledge of noise management
Time frame: 1 hour within the end of the lecture on noise management for medical staff
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiaohua Ge principal investigator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing noise management in people with Noise Exposure and Delirium, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaohua Ge (+86-18616706778, gexiaohua@shsmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Noise exposure (time frame: Average of 1 weak). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2020.