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Noise Impact in the Post-anesthesia Care Unit (Post op NOISE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03537820
Recruitment Status : Completed
First Posted : May 25, 2018
Last Update Posted : October 29, 2018
Sponsor:
Information provided by (Responsible Party):
CHU de Reims

Brief 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. 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.

Condition or disease Intervention/treatment
All Surgery Other: questionnaire

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.

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Study Type : Observational
Actual Enrollment : 816 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Relationship Between Noise Level and Patients Satisfaction in Post Anesthesia Care Units
Actual Study Start Date : March 5, 2018
Actual Primary Completion Date : May 4, 2018
Actual Study Completion Date : May 4, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Noise

Group/Cohort Intervention/treatment
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
Other: questionnaire
questionnaire EVAN-G

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
Other: questionnaire
questionnaire EVAN-G




Primary Outcome Measures :
  1. patient's unpleasantness due to the noise [ Time Frame: day 1 ]
    visual analog scale EVAN-G



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patient with scheduled surgery
Criteria

inclusion criteria :

  • 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

exclusion criteria :

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03537820


Locations
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France
Chu Reims
Reims, France, 51092
Sponsors and Collaborators
CHU de Reims
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Responsible Party: CHU de Reims
ClinicalTrials.gov Identifier: NCT03537820    
Other Study ID Numbers: PO18016
First Posted: May 25, 2018    Key Record Dates
Last Update Posted: October 29, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No