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

October 25, 2018 updated by: CHU de Reims

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

816

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Reims, France, 51092
        • CHU Reims

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patient with scheduled surgery

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
patient's unpleasantness due to the noise
Time Frame: day 1
visual analog scale EVAN-G
day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CHU de Reims

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 5, 2018

Primary Completion (Actual)

May 4, 2018

Study Completion (Actual)

May 4, 2018

Study Registration Dates

First Submitted

May 15, 2018

First Submitted That Met QC Criteria

May 15, 2018

First Posted (Actual)

May 25, 2018

Study Record Updates

Last Update Posted (Actual)

October 29, 2018

Last Update Submitted That Met QC Criteria

October 25, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • PO18016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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