This trial is active, not recruiting.

Condition preoperative area
Treatment questionnaires
Sponsor Hospices Civils de Lyon
Start date March 2016
End date April 2016
Trial size 1000 participants
Trial identifier NCT02811107, 69HCL16_0075


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Patients in preoperative area before surgery or interventional procedure will complete questionnaires on tablet computers
Completion of questionnaires on tablet computers in the preoperative area by 6 nurse anesthetists, 1 hospital physician and 1 resident physician.

Primary Outcomes

Evaluation of anxiety in preoperative area, by using 3 questionnaires.
time frame: Day 0

Secondary Outcomes

Evaluation of sedation
time frame: Day 0
Evaluation of pain
time frame: Day 0
Experiences of patient
time frame: Day 0
Evaluation of patient premedication
time frame: Day 0

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Evaluation of Anxiety in Surgery Preoperative Area (ASDT)
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Hospices Civils de Lyon.