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Clinical Trials/NCT02811107
NCT02811107
Unknown
Not Applicable

Evaluation of Anxiety in Surgery Preoperative Area (ASDT)

Hospices Civils de Lyon0 sites1,000 target enrollmentMarch 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Preoperative Area
Sponsor
Hospices Civils de Lyon
Enrollment
1000
Primary Endpoint
Evaluation of anxiety in preoperative area, by using 3 questionnaires.
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 2016
End Date
December 2016
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Exclusion Criteria

  • \< 18 years

Outcomes

Primary Outcomes

Evaluation of anxiety in preoperative area, by using 3 questionnaires.

Time Frame: Day 0

With 3 questionnaires: * visual analog scale of anxiety * APAIS score * COVI Score

Secondary Outcomes

  • Evaluation of pain(Day 0)
  • Evaluation of patient premedication(Day 0)
  • Evaluation of sedation(Day 0)
  • Experiences of patient(Day 0)

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