Preoperative AreaASDTNCT02811107
Evaluation of Anxiety in Surgery Preoperative Area (ASDT)
An observational study of Preoperative Area, run by Hospices Civils de Lyon.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Preoperative Area
- What is being tested?
- Questionnaires
- Type of treatment
- Pill or oral medicine
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- Mar 2016to Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient in preoperative area before surgery or interventional procedure
Who may be able to join
- 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.
Who cannot join
- < 18 years
About this study
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.
Read more
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
- Being tested
- Questionnaires
- Keywords
- anxiety, pain, preoperative area, premedication
- Medical subject headings
- Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
Completion of questionnaires on tablet computers in the preoperative area by 6 nurse anesthetists, 1 hospital physician and 1 resident physician.
| Study group | Role | What they receive |
|---|---|---|
| Patients in preoperative area | Patients in preoperative area before surgery or interventional procedure will complete questionnaires on tablet computers Receives: Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of anxiety in preoperative area, by using 3 questionnaires.
With 3 questionnaires:
- visual analog scale of anxiety
- APAIS score
- COVI Score
Measured: Day 0
Secondary outcomes (4)
Evaluation of sedation
Scale of sedation (during the stay in preoperative area)
Measured: Day 0
Evaluation of pain
visual analog scale of pain (during the stay in preoperative area)
Measured: Day 0
Experiences of patient
questionnaire (during the stay in preoperative area)
Measured: Day 0
Evaluation of patient premedication
questionnaire (during the stay in preoperative area)
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2016 (estimated)
- Study startMar 2016
- Primary completionApr 2016
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preoperative AreaStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02811107
- Sponsor's protocol ID
- 69HCL16_0075
- Acronym
- ASDT
- Status last verified
- Jun 2016
- First submitted
- 21 Jun 2016
- Last updated
- 23 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Anxiety in Surgery Preoperative Area (ASDT)
- ClinicalTrials.gov ID
- NCT02811107
- Acronym / sponsor ID
- ASDT / 69HCL16_0075
- Conditions
- Preoperative Area
- Keywords
- anxiety, pain, preoperative area, premedication
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Apr 2016 (actual)
- Study completion
- Dec 2016 (estimated)
- First posted
- 23 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients in preoperative area | – | Other: QuestionnairesPatients in preoperative area before surgery or interventional procedure will complete questionnaires on tablet computers |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient in preoperative area before surgery or interventional procedure
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- < 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnairesCompletion of questionnaires on tablet computers in the preoperative area by 6 nurse anesthetists, 1 hospital physician and 1 resident physician. | Other | Patients in preoperative area |
Primary outcome
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
4 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Preoperative Area, run by Hospices Civils de Lyon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of anxiety in preoperative area, by using 3 questionnaires. (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2016.