Evaluation of Anxiety in Surgery Preoperative Area (ASDT)

NCT02811107 | Unknown

• 1 other identifier: 69HCL16_0075
• Study Type: observational
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Preoperative Area

Keywords

anxiety; pain; preoperative area; premedication

Outcome Measures

Primary Outcomes (1)

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

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

  Day 0

Secondary Outcomes (4)

• Evaluation of sedation

  Day 0

• Evaluation of pain

  Day 0

• Experiences of patient

  Day 0

• Evaluation of patient premedication

  Day 0

Study Arms (1)

Patients in preoperative area

Patients in preoperative area before surgery or interventional procedure will complete questionnaires on tablet computers

Other: Questionnaires

Interventions

Questionnaires OTHER

Completion of questionnaires on tablet computers in the preoperative area by 6 nurse anesthetists, 1 hospital physician and 1 resident physician.

Patients in preoperative area

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient in preoperative area before surgery or interventional procedure

You may qualify if:

• 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.

You may not qualify if:

• \< 18 years

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

MeSH Terms

Conditions

Anxiety Disorders; Pain

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2016
• First Posted: June 23, 2016
• Study Start: March 1, 2016
• Primary Completion: April 1, 2016
• Study Completion: December 1, 2016
• Last Updated: June 23, 2016

Record last verified: 2016-06