Evaluation of Anxiety in Surgery Preoperative Area (ASDT) (ASDT)

June 22, 2016 updated by: Hospices Civils de Lyon

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patient in preoperative area before surgery or interventional procedure

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients in preoperative area
Patients in preoperative area before surgery or interventional procedure will complete questionnaires on tablet computers
Other: Questionnaires
Completion of questionnaires on tablet computers in the preoperative area by 6 nurse anesthetists, 1 hospital physician and 1 resident physician.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Day 0

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of sedation
Time Frame: Day 0
Scale of sedation (during the stay in preoperative area)
Day 0
Evaluation of pain
Time Frame: Day 0
visual analog scale of pain (during the stay in preoperative area)
Day 0
Experiences of patient
Time Frame: Day 0
questionnaire (during the stay in preoperative area)
Day 0
Evaluation of patient premedication
Time Frame: Day 0
questionnaire (during the stay in preoperative area)
Day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (ACTUAL)

April 1, 2016

Study Completion (ANTICIPATED)

December 1, 2016

Study Registration Dates

First Submitted

June 21, 2016

First Submitted That Met QC Criteria

June 22, 2016

First Posted (ESTIMATE)

June 23, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

June 23, 2016

Last Update Submitted That Met QC Criteria

June 22, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 69HCL16_0075

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Preoperative Area

Clinical Trials on Questionnaires

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uzbekistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe