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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03537820
Other study ID # PO18016
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 5, 2018
Est. completion date May 4, 2018

Study information

Verified date October 2018
Source CHU de Reims
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 816
Est. completion date May 4, 2018
Est. primary completion date May 4, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
questionnaire
questionnaire EVAN-G

Locations

Country Name City State
France Chu Reims Reims

Sponsors (1)

Lead Sponsor Collaborator
CHU de Reims

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary patient's unpleasantness due to the noise visual analog scale EVAN-G day 1