AnesthesiaNCT03818464
Psychological Assessment Before General Anesthesia (VeSPPA2018)
An observational study of Anesthesia, run by University of Parma at 1 site in Italy.
Trial summary
The level of preoperative anxiety can be related to the outcome of an operation and to the post operative patient management . The Dutch questionnaire APAIS (Amsterdam Preoperative Anxiety and Information Scale) is a useful tool to quantify this parameter, and it has been translated and validated by the University… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Anesthesia
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 10 Feb 2019to 10 Mar 2021
- How long will I take part?
- 1 Week
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Non-critically ill patients undergoing general anesthesia before elective surgery.
Who may be able to join
- Adult patient aged between 18 and 75 years.
- Degrees I, II and III of the ASA Classification (Classification of the physical condition of the patient).
- Patients under general anesthesia for major abdominal surgery in election.
- Adult aware and informed that he has signed the informed consent form.
Who cannot join
- Patient who refuses to sign informed consent.
- Patient under general anesthesia for emergency surgery.
- Patient with an established diagnosis and / or in therapy for serious diseases of the emotional sphere, major depression or severe psychosis.
- Patient with history of drug addiction and / or alcohol abuse.
Trial locations and contacts
1 site in 1 country.
Elena Giovanna Bignami, Professor of Anesthesiology contact
Italy1 site
Azienda Ospedaliero-Universitaria di Parma
Parma, Italy (pr), 43126
Elena Giovanna Bignami, MD Professor, +3905211033609, elenagiovanna.bignami@unipr.it
About this study
Official title: Pre-operative Psychological Assessment of Patients Undergoing General Anesthesia in Abdominal Surgery
The level of preoperative anxiety can be related to the outcome of an operation and to the post operative patient management .
The Dutch questionnaire APAIS (Amsterdam Preoperative Anxiety and Information Scale) is a useful tool to quantify this parameter, and it has been translated and validated by the University Federico II of Naples in the study "Italian validation of the Amsterdam Preoperative Anxiety and Information Scale".
Read more
The study aims at identifying the correlation between the preoperative anxiety level measured by the APAIS in adult patients in general anesthesia undergoing elective major abdominal surgery and the levels of post-operative pain measured by the VAS (Visual Analogue Scale) and NRS (Numeric Rating Scale) scales.
Post-operative pain and agitation in the patient can be lessened through the objective assessment of preoperative anxiety and its treatment.
Read the detailed description
Background and aim:
Anxiety is the body's physiological response to danger. It is a complex combination of emotions and fear, which leads to developing the typical symptoms of the "fight or flight" mode, as well as hyperactivity of the sympathetic nervous system which causes the body to release the adrenal "stress hormones" (cortisol, noradrenaline and adrenaline).
Anxiety reaction is commonly experienced by patients undergoing surgeries, as these are perceived as dangerous situations that cause the patient to feel powerless. Clinical practice has shown that patients are concerned not only about the surgery itself but also about the state of unconsciousness in which they enter because of general anesthesia. General anesthesia is a medically induced coma which is temporary and reversible. It is obtained by administering drugs to the patient, and it consists of three components - hypnosis, analgesia and muscle relaxation.
The procedure can be broken down in the following phases:
medication - the patient is administered anxiolytic drugs.
Induction of general anesthesia - loss of consciousness and respiratory arrest; breathing supported by mechanical ventilation.
Maintenance - surgery is carried out.
Emergence from anesthesia - administration of anesthetics is ceased and spontaneous breathing resumes.
Anxious patients have hyperarousal of the sympathetic nervous system, which affects the management of general anesthesia; with these patients, medication dosing will need to be adjusted in order to counterbalance the hemodynamic and metabolic consequences caused by this hyperarousal.
The following hypothesis is the aim of the study: to identify a significant number of correlations between the preoperative anxiety levels (quantified by the APAIS questionnaire), postoperative pain (quantified by the VAS and NRS scales), and the objective biological parameters displayed in the crf.
Gathering such data precedes considering whether the modulation of preoperative anxiety can affect positively the patient's outcome.
As a matter of fact, it is considered that reducing preoperative anxiety (for example through doctor-patient conversation or administration of anxiolytic drugs) allows an improving of postoperative physical and psychological conditions.
Medical literature on this topic shows that the preoperative anxiety level can be related to the outcome of an operation and to the post-operative patient management. In 1996, the Dutch Nelly Moerman, Martin J. Muller, F. S. van Dam and Hans Oosting introduced the Amsterdam Preoperative Anxiety and Information Scale (APAIS) - a scale for the objective assessment of anxiety.
It is a quick questionnaire consisting of 6 questions; its purpose is to investigate in detail the patient's anxiety and his/her need of information about general anesthesia and the surgery he/she will undergo. The questionnaire is easy to use and precise, which led to a widespread use of the APAIS scale.
In Italy, the APAIS scale has been the subject matter of the study "Italian validation of the Amsterdam Preoperative Anxiety and Information Scale" carried out by the the University Federico II of Naples. This study demonstrated that the scale measured effectively the preoperative anxiety level in that portion of Italian population undergoing surgery, and it reliably identifies pathological anxiety. In fact, there are cases in which anxiety is not an adaptive (thus physiological) response, but it reveals to be maladaptive (and thus pathological). When present in the preoperative phase, this type of anxiety can strongly affect a surgery's outcome.
The study aims at using the APAIS scale to measure preoperative anxiety levels in adult patients in general anesthesia undergoing elective major abdominal surgery, and then assess the correlation between the anxiety levels and the patient's wellbeing in the postoperative phase. The investigators believes that the management of both surgery and patient's postoperative pain can be improved through an objective assessment of preoperative anxiety and its treatment. The questionnaire allows to obtain a certain score corresponding to a certain level of anxiety in the patient (in the Italian translation of APAIS, the score >14 corresponds to "pathological anxiety"). The work aims at identifying a significant number of correlations between this score and the pain and between anxiety and the variation of biological parameters displayed in the cfr (frequency, blood pressure, hemoglobin, and so on).
- Conditions
- Anesthesia
- Keywords
- pre-operative assessment, postoperative pain, biological complications
- Medical subject headings
- Pain, Postoperative
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between anxiety level and postoperative pain
Identify the correlation between the preoperative patient anxiety level measured by APAIS (Amsterdam Preoperative Anxiety and Information Scale) and the postoperative pain levels measured using the VAS (Visual Analogue Scale). The evaluation range of Apais scale is from one (the lower level with better outcome) to five (the maximum level with worse outcome). The VAS Scale is made of six smiles from zero (the lower level with better outcome) to five ( the maximum level of pain with worse outcome).
Measured: from before induction of general anesthesia until the end of recovery, up to 3 days
Correlation between anxiety level and postoperative pain
Identify the correlation between the preoperative patient anxiety level measured by APAIS (Amsterdam Preoperative Anxiety and Information Scale) and the postoperative pain levels measured using the NRS (Numeric Rating Scales). The evaluation range of Apais scale is from one (the lower level with better outcome) to five (the maximum level with worse outcome). The evaluation range of NRS scale is from zero ( the lower level with better outcome) to ten (the maximum level with worse outcome).
Measured: from before induction of general anesthesia until the end of recovery, up to 3 days
Level of agitation at the time of extubation
Evaluate the level of agitation at the time of extubation through the BARS scale (Behavioral Activity Rating Scale). The evaluation range of the Bars scale is from one (the lower level with better outcome) to seven (the maximum level with worse outcome)
Measured: from the time of extubation until the end of recovery, up to 3 days
Level of agitation at the time of extubation
Evaluate the level of agitation at the time of extubation through the RAMSAY Score (Ramsay Sedation Scale). The evaluation range of the Ramsay score is from one (the lower level with better outcome ) to six (the maximum level with worse outcome).
Measured: from the time of extubation until the end of recovery, up to 3 days
Secondary outcomes (6)
Evaluate treatment of anxiety
Pre-operative anxiety will be evaluated through APAIS (Amsterdam Preoperative Anxiety and Information Scale) questionnaire, for set the optimal type and dosage (mg/Kg) of drugs given for anxiety treatment.
Measured: from the time of awakening until the end of recovery, up to 3 days
Evaluate treatment of pain
Post operative pain will be evaluated through VAS (Visual Analogue Scale) score, for set the optimal type and dosage (mg/Kg) of drugs given for pain treatment.
The VAS Scale is made of six smiles from zero (the lower level with better outcome) to five ( the maximum level of pain with worse outcome).
Measured: from the time of awakening until the end of recovery, up to 3 days
Evaluate treatment of pain
Post operative pain will be evaluated through NRS (Numeric Rating Scale) score, for set the optimal type and dosage (mg/Kg) of drugs given for pain treatment. The evaluation range of NRS scale is from zero ( the lower level with better outcome) to ten (the maximum level with worse outcome).
Measured: from the time of awakening until the end of recovery, up to 3 days
Patient's emotional background
To investigate the patient's emotional background on the experience of general anesthesia through post-operative interviews
Measured: from the time of awakening until the end of recovery, up to 3 days
Neoplastic patient
Evaluate the presence of any APAIS (Amsterdam Preoperative Anxiety and Information Scale) score differences in patients with and without neoplasia. The evaluation range of Apais scale is from one (the lower level with better outcome) to five (the maximum level with worse outcome)
Measured: from the time of awakening until the end of recovery, up to 3 days
Postoperative complications
Evaluate the incidence of postoperative complications such as hypoxia, correlating the APAIS (Amsterdam Preoperative Anxiety and Information Scale) score in the preoperative with the values of arterial pressure, heart rate, oxygen saturation, hemoglobin and hematocrit in the postoperative
Measured: from the time of awakening until the end of recovery, up to 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2019
- Study start10 Feb 2019 (estimated)
- Primary completion10 Feb 2020 (estimated)
- Study completion10 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- 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
- 100 participants (estimated)
- Target duration
- 1 Week
Sponsor and investigators
- Lead sponsor
- University of Parma
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elena Giovanna Bignami, University of Parma
- Investigators
- Raffaella Troglio, MD, Principal investigator, Azienda Ospedaliero-Universitaria di ParmaAndrea Bonetti, MD, Principal investigator, Azienda Ospedaliero-Universitaria di ParmaMirko Bottari, MD, Principal investigator, Azienda Ospedaliero-Universitaria di ParmaFederica Cassè, MD, Principal investigator, Azienda Ospedaliero-Universitaria di ParmaFederica Causo, MD, Principal investigator, Azienda Ospedaliero-Universitaria di ParmaJessica Colla, MD, Principal investigator, Azienda Ospedaliero-Universitaria di ParmaPierCarlo Cottone, MD, Principal investigator, Azienda Ospedaliero-Universitaria di ParmaMarco DiLecce, MD, Principal investigator, Azienda Ospedaliero-Universitaria di Parma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03818464
- Sponsor's protocol ID
- 730/2018/OSS/AOUPR
- Status last verified
- Jan 2019
- First submitted
- 21 Jan 2019
- Last updated
- 30 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-operative Psychological Assessment of Patients Undergoing General Anesthesia in Abdominal Surgery
- ClinicalTrials.gov ID
- NCT03818464
- Acronym / sponsor ID
- 730/2018/OSS/AOUPR
- Conditions
- Anesthesia
- Keywords
- pre-operative assessment, postoperative pain, biological complications
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of ParmaUniversity, hospital or other
- Study start
- 10 Feb 2019 (estimated)
- Primary completion
- 10 Feb 2020 (estimated)
- Study completion
- 10 Mar 2021 (estimated)
- First posted
- 28 Jan 2019 (actual)
- 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.
The level of preoperative anxiety can be related to the outcome of an operation and to the post operative patient management .
The Dutch questionnaire APAIS (Amsterdam Preoperative Anxiety and Information Scale) is a useful tool to quantify this parameter, and it has been translated and validated by the University Federico II of Naples in the study "Italian validation of the Amsterdam Preoperative Anxiety and Information Scale".
The study aims at identifying the correlation between the preoperative anxiety level measured by the APAIS in adult patients in general anesthesia undergoing elective major abdominal surgery and the levels of post-operative pain measured by the VAS (Visual Analogue Scale) and NRS (Numeric Rating Scale) scales.
Post-operative pain and agitation in the patient can be lessened through the objective assessment of preoperative anxiety and its treatment.
Detailed description
Background and aim:
Anxiety is the body's physiological response to danger. It is a complex combination of emotions and fear, which leads to developing the typical symptoms of the "fight or flight" mode, as well as hyperactivity of the sympathetic nervous system which causes the body to release the adrenal "stress hormones" (cortisol, noradrenaline and adrenaline).
Anxiety reaction is commonly experienced by patients undergoing surgeries, as these are perceived as dangerous situations that cause the patient to feel powerless. Clinical practice has shown that patients are concerned not only about the surgery itself but also about the state of unconsciousness in which they enter because of general anesthesia. General anesthesia is a medically induced coma which is temporary and reversible. It is obtained by administering drugs to the patient, and it consists of three components - hypnosis, analgesia and muscle relaxation.
The procedure can be broken down in the following phases:
medication - the patient is administered anxiolytic drugs.
Induction of general anesthesia - loss of consciousness and respiratory arrest; breathing supported by mechanical ventilation.
Maintenance - surgery is carried out.
Emergence from anesthesia - administration of anesthetics is ceased and spontaneous breathing resumes.
Anxious patients have hyperarousal of the sympathetic nervous system, which affects the management of general anesthesia; with these patients, medication dosing will need to be adjusted in order to counterbalance the hemodynamic and metabolic consequences caused by this hyperarousal.
The following hypothesis is the aim of the study: to identify a significant number of correlations between the preoperative anxiety levels (quantified by the APAIS questionnaire), postoperative pain (quantified by the VAS and NRS scales), and the objective biological parameters displayed in the crf.
Gathering such data precedes considering whether the modulation of preoperative anxiety can affect positively the patient's outcome.
As a matter of fact, it is considered that reducing preoperative anxiety (for example through doctor-patient conversation or administration of anxiolytic drugs) allows an improving of postoperative physical and psychological conditions.
Medical literature on this topic shows that the preoperative anxiety level can be related to the outcome of an operation and to the post-operative patient management. In 1996, the Dutch Nelly Moerman, Martin J. Muller, F. S. van Dam and Hans Oosting introduced the Amsterdam Preoperative Anxiety and Information Scale (APAIS) - a scale for the objective assessment of anxiety.
It is a quick questionnaire consisting of 6 questions; its purpose is to investigate in detail the patient's anxiety and his/her need of information about general anesthesia and the surgery he/she will undergo. The questionnaire is easy to use and precise, which led to a widespread use of the APAIS scale.
In Italy, the APAIS scale has been the subject matter of the study "Italian validation of the Amsterdam Preoperative Anxiety and Information Scale" carried out by the the University Federico II of Naples. This study demonstrated that the scale measured effectively the preoperative anxiety level in that portion of Italian population undergoing surgery, and it reliably identifies pathological anxiety. In fact, there are cases in which anxiety is not an adaptive (thus physiological) response, but it reveals to be maladaptive (and thus pathological). When present in the preoperative phase, this type of anxiety can strongly affect a surgery's outcome.
The study aims at using the APAIS scale to measure preoperative anxiety levels in adult patients in general anesthesia undergoing elective major abdominal surgery, and then assess the correlation between the anxiety levels and the patient's wellbeing in the postoperative phase. The investigators believes that the management of both surgery and patient's postoperative pain can be improved through an objective assessment of preoperative anxiety and its treatment. The questionnaire allows to obtain a certain score corresponding to a certain level of anxiety in the patient (in the Italian translation of APAIS, the score >14 corresponds to "pathological anxiety"). The work aims at identifying a significant number of correlations between this score and the pain and between anxiety and the variation of biological parameters displayed in the cfr (frequency, blood pressure, hemoglobin, and so on).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Week
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Non-critically ill patients undergoing general anesthesia before elective surgery.
Key inclusion criteria (4 listed)
- Adult patient aged between 18 and 75 years.
- Degrees I, II and III of the ASA Classification (Classification of the physical condition of the patient).
- Patients under general anesthesia for major abdominal surgery in election.
- Adult aware and informed that he has signed the informed consent form.
Key exclusion criteria (4 listed)
- Patient who refuses to sign informed consent.
- Patient under general anesthesia for emergency surgery.
- Patient with an established diagnosis and / or in therapy for serious diseases of the emotional sphere, major depression or severe psychosis.
- Patient with history of drug addiction and / or alcohol abuse.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation between anxiety level and postoperative pain
Time frame: from before induction of general anesthesia until the end of recovery, up to 3 days
Identify the correlation between the preoperative patient anxiety level measured by APAIS (Amsterdam Preoperative Anxiety and Information Scale) and the postoperative pain levels measured using the VAS (Visual Analogue Scale). The evaluation range of Apais scale is from one (the lower level with better outcome) to five (the maximum level with worse outcome). The VAS Scale is made of six smiles from zero (the lower level with better outcome) to five ( the maximum level of pain with worse outcome).
Correlation between anxiety level and postoperative pain
Time frame: from before induction of general anesthesia until the end of recovery, up to 3 days
Identify the correlation between the preoperative patient anxiety level measured by APAIS (Amsterdam Preoperative Anxiety and Information Scale) and the postoperative pain levels measured using the NRS (Numeric Rating Scales). The evaluation range of Apais scale is from one (the lower level with better outcome) to five (the maximum level with worse outcome). The evaluation range of NRS scale is from zero ( the lower level with better outcome) to ten (the maximum level with worse outcome).
Level of agitation at the time of extubation
Time frame: from the time of extubation until the end of recovery, up to 3 days
Evaluate the level of agitation at the time of extubation through the BARS scale (Behavioral Activity Rating Scale). The evaluation range of the Bars scale is from one (the lower level with better outcome) to seven (the maximum level with worse outcome)
Level of agitation at the time of extubation
Time frame: from the time of extubation until the end of recovery, up to 3 days
Evaluate the level of agitation at the time of extubation through the RAMSAY Score (Ramsay Sedation Scale). The evaluation range of the Ramsay score is from one (the lower level with better outcome ) to six (the maximum level with worse outcome).
6 secondary outcomes
Evaluate treatment of anxiety
Time frame: from the time of awakening until the end of recovery, up to 3 days
Evaluate treatment of pain
Time frame: from the time of awakening until the end of recovery, up to 3 days
Evaluate treatment of pain
Time frame: from the time of awakening until the end of recovery, up to 3 days
Patient's emotional background
Time frame: from the time of awakening until the end of recovery, up to 3 days
Neoplastic patient
Time frame: from the time of awakening until the end of recovery, up to 3 days
Postoperative complications
Time frame: from the time of awakening until the end of recovery, up to 3 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2019.
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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.
Elena Giovanna Bignami, Professor of Anesthesiology contact
Raffaella Troglio, MD principal investigator
Azienda Ospedaliero-Universitaria di Parma
Andrea Bonetti, MD principal investigator
Azienda Ospedaliero-Universitaria di Parma
Mirko Bottari, MD principal investigator
Azienda Ospedaliero-Universitaria di Parma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia, run by University of Parma at 1 site in Italy.
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 4 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 30 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Elena Giovanna Bignami, Professor of Anesthesiology (+3905211033609, elenagiovanna.bignami@unipr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between anxiety level and postoperative pain (time frame: from before induction of general anesthesia until the end of recovery, up to 3 days). The study lists 4 primary outcomes in all. 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 30 Jan 2019.