NCT03537820

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
816

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 5, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 4, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 4, 2018

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

May 15, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 25, 2018

Completed
Last Updated

October 29, 2018

Status Verified

October 1, 2018

Enrollment Period

2 months

First QC Date

May 15, 2018

Last Update Submit

October 25, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • patient's unpleasantness due to the noise

    visual analog scale EVAN-G

    day 1

Study Arms (2)

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

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

Interventions

questionnaire EVAN-G

after nurses formation/installation of a noise warning devicebefore nurses formation/installation of a noise warning device

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patient with scheduled surgery

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Reims

Reims, 51092, France

Location

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 15, 2018

First Posted

May 25, 2018

Study Start

March 5, 2018

Primary Completion

May 4, 2018

Study Completion

May 4, 2018

Last Updated

October 29, 2018

Record last verified: 2018-10

Locations