Evaluation of Anxiety in Surgery Preoperative Area (ASDT)

• Conditions: Preoperative Area
• Interventions: Other: Questionnaires

• Registration Number: NCT02811107
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

Anxiety is associated with discomfort but also with an increased risk of pain and/or analgesic consumption. A prescription of anxiolytics is very common in pre-anesthetic consultation but without considering the real anxiety level of the patients. The objective of this premedication is mainly to improve patient comfort, to reduce patient anxiety and to improve patient cooperation.

According to a study conducted in the 1990s, 40 to 80% of patients are anxious before surgery.

Consequences of anxiety are somatic (tachycardia, hypertension, difficulty to falling asleep), behavioural (aggressiveness, regression, fight against anaesthesia induction) and postoperative pain.

Preoperative area is a place of convergence for patients who need surgery or an interventional procedure.

Staying in the preoperative area may be a source of anxiety and may affect the patient management.

The investigators will interview patients undergoing surgery or interventional procedure to assess their level of anxiety, pain and their experiences during their stay in preoperative area. The objective is to analyse the level of anxiety and / or pain and their clinical consequences, and then to assess the relationship with any potential premedication.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design

Study Timeline

• Study Start: 2016-03
• Primary Completion: 2016-04
• Status Verified: 2016-06
• Study First Submitted: 2016-06-21
• Study First Submitted QC: 2016-06-22
• Last Update Submitted: 2016-06-22
• Study First Posted: 2016-06-23
• Last Update Posted: 2016-06-23
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• Patient in preoperative area before surgery or interventional procedure
• Patient to receive general anesthesia, local, locoregional, sedation,
• Agreeing to participate in the study after receiving information note,
• ≥ 18 years of age.

Read More

Exclusion Criteria

• < 18 years

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients in preoperative area	Questionnaires	Patients in preoperative area before surgery or interventional procedure will complete questionnaires on tablet computers

Primary Outcome Measures

Name	Time	Method
Evaluation of anxiety in preoperative area, by using 3 questionnaires.	Day 0	With 3 questionnaires: * visual analog scale of anxiety; * APAIS score; * COVI Score

Secondary Outcome Measures

Name	Time	Method
Evaluation of pain	Day 0	visual analog scale of pain (during the stay in preoperative area)
Evaluation of patient premedication	Day 0	questionnaire (during the stay in preoperative area)
Evaluation of sedation	Day 0	Scale of sedation (during the stay in preoperative area)
Experiences of patient	Day 0	questionnaire (during the stay in preoperative area)