All SurgeryPost op NOISENCT03537820
Noise Impact in the Post-anesthesia Care Unit
An observational study of All Surgery, run by CHU de Reims at 1 site in France.
Trial summary
World health organization recommends noise level should be less than 30db in hospital. However many analysis conclude to an average of 67dB in the post anesthesia care unit. No many studies were reported about noise impact in a post-anesthesia care unit. Only one was published by B.Allaouchiche in 2002. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- All Surgery
- What is being tested?
- questionnaire
- How many people
- 816 participants
- Where
- 1 siteFrance
- Study dates
- 5 Mar 2018to 4 May 2018
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patient with scheduled surgery
Who may be able to join
- patient who have a scheduled surgery in University hospital of Reims
- patient who stay in the post-anesthesia care unit
- patient consenting to participate to the study
- patient older than 18 years
Who cannot join
- Emergency surgery
- Patients who have been hearing disorders (notice in the preoperative consultation)
- Patients who have cognitive disorders (notice in the preoperative consultation)
- Patients who have a medical history of ear/cerebral surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Relationship Between Noise Level and Patients Satisfaction in Post Anesthesia Care Units
World health organization recommends noise level should be less than 30db in hospital. However many analysis conclude to an average of 67dB in the post anesthesia care unit. No many studies were reported about noise impact in a post-anesthesia care unit. Only one was published by B.Allaouchiche in 2002. However, noise is a complaint reported by patients and it could be responsible for physiological and psychological troubles. In this prospective study, the main objective is to determine patients' satisfaction in the post anesthesia care unit, before and after installation of a noise warning device. Between the two parts, a short training about noise consequences on health will be presented to nurses. Improvement off anti-noise actions on patient's satisfaction will analysed.
Read the detailed description
Although the post- anesthesia care unit can be noisy, the effect of noise on patients recovering from anesthesia is unknown. Indeed, many studies are achieved in reanimation or ICU. That's why this prospective study is about patients' satisfaction after their stay in the post-anesthesia care unit. In a first part, noise is just measured with a sound level meter and patients are asked about their experience. Before the second part, during few days, nurses will be informed about noise consequences on heath. With some precaution, a decrease of the sound level in a room (ex: decrease scope alarms, speaking quietly, not slamming the drawer, noise warning device…) will be expected. The main objective is to determine the patient's satisfaction in the post-anesthesia care unit before and after installation of a noise warning device.
- Conditions
- All Surgery
- Being tested
- questionnaire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaireOther
questionnaire EVAN-G
| Study group | Role | What they receive |
|---|---|---|
| before nurses formation/installation of a noise warning device | ambulatory or hospitalized patients, who go in post-anesthesia care unit, before nurses formation and installation of a noise warning device Receives: Other: questionnaire | |
| after nurses formation/installation of a noise warning device | ambulatory or hospitalized patients, who go in post-anesthesia care unit, after nurses formation and installation of a noise warning device Receives: Other: questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
patient's unpleasantness due to the noise
visual analog scale EVAN-G
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2018
- Study start5 Mar 2018
- Primary completion4 May 2018
- Study completion4 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for All SurgeryStudies of the same condition, open and under way.
- More trials run by CHU de ReimsThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 816 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03537820
- Sponsor's protocol ID
- PO18016
- Acronym
- Post op NOISE
- Status last verified
- Oct 2018
- First submitted
- 15 May 2018
- Last updated
- 29 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Noise Level and Patients Satisfaction in Post Anesthesia Care Units
- ClinicalTrials.gov ID
- NCT03537820
- Acronym / sponsor ID
- Post op NOISE / PO18016
- Conditions
- All Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 816 participants (actual)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- 5 Mar 2018 (actual)
- Primary completion
- 4 May 2018 (actual)
- Study completion
- 4 May 2018 (actual)
- First posted
- 25 May 2018 (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.
World health organization recommends noise level should be less than 30db in hospital. However many analysis conclude to an average of 67dB in the post anesthesia care unit. No many studies were reported about noise impact in a post-anesthesia care unit. Only one was published by B.Allaouchiche in 2002. However, noise is a complaint reported by patients and it could be responsible for physiological and psychological troubles. In this prospective study, the main objective is to determine patients' satisfaction in the post anesthesia care unit, before and after installation of a noise warning device. Between the two parts, a short training about noise consequences on health will be presented to nurses. Improvement off anti-noise actions on patient's satisfaction will analysed.
Detailed description
Although the post- anesthesia care unit can be noisy, the effect of noise on patients recovering from anesthesia is unknown. Indeed, many studies are achieved in reanimation or ICU. That's why this prospective study is about patients' satisfaction after their stay in the post-anesthesia care unit. In a first part, noise is just measured with a sound level meter and patients are asked about their experience. Before the second part, during few days, nurses will be informed about noise consequences on heath. With some precaution, a decrease of the sound level in a room (ex: decrease scope alarms, speaking quietly, not slamming the drawer, noise warning device…) will be expected. The main objective is to determine the patient's satisfaction in the post-anesthesia care unit before and after installation of a noise warning device.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| before nurses formation/installation of a noise warning device | – | Other: questionnaireambulatory or hospitalized patients, who go in post-anesthesia care unit, before nurses formation and installation of a noise warning device |
| after nurses formation/installation of a noise warning device | – | Other: questionnaireambulatory or hospitalized patients, who go in post-anesthesia care unit, after nurses formation and installation of a noise warning device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patient with scheduled surgery
Key inclusion criteria (4 listed)
- patient who have a scheduled surgery in University hospital of Reims
- patient who stay in the post-anesthesia care unit
- patient consenting to participate to the study
- patient older than 18 years
Key exclusion criteria (4 listed)
- Emergency surgery
- Patients who have been hearing disorders (notice in the preoperative consultation)
- Patients who have cognitive disorders (notice in the preoperative consultation)
- Patients who have a medical history of ear/cerebral surgery
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 |
|---|---|---|
| questionnairequestionnaire EVAN-G | Other | after nurses formation/installation of a noise warning device, before nurses formation/installation of a noise warning device |
Primary outcome
patient's unpleasantness due to the noise
Time frame: day 1
visual analog scale EVAN-G
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2018.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of All Surgery, run by CHU de Reims at 1 site in France.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 29 Oct 2018. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
patient's unpleasantness due to the noise (time frame: day 1). 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 29 Oct 2018.