Psychological Assessment Before General Anesthesia (VeSPPA2018)

NCT03818464 | Unknown

• 1 other identifier: 730/2018/OSS/AOUPR
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Anesthesia

Keywords

pre-operative assessment; postoperative pain; biological complications

Outcome Measures

Primary Outcomes (4)

• 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).

  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).

  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)

  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).

  from the time of extubation until the end of recovery, up to 3 days

Secondary Outcomes (6)

• Evaluate treatment of anxiety

  from the time of awakening until the end of recovery, up to 3 days

• Evaluate treatment of pain

  from the time of awakening until the end of recovery, up to 3 days

• Evaluate treatment of pain

  from the time of awakening until the end of recovery, up to 3 days

• Patient's emotional background

  from the time of awakening until the end of recovery, up to 3 days

• Neoplastic patient

  from the time of awakening until the end of recovery, up to 3 days

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Non-critically ill patients undergoing general anesthesia before elective surgery.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Parma: lead

Study Sites (1)

Azienda Ospedaliero-Universitaria di Parma

Parma, Italy (pr), 43126, Italy

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Raffaella Troglio, MD

  Azienda Ospedaliero-Universitaria di Parma

  PRINCIPAL INVESTIGATOR

• Andrea Bonetti, MD

  Azienda Ospedaliero-Universitaria di Parma

  PRINCIPAL INVESTIGATOR

• Mirko Bottari, MD

  Azienda Ospedaliero-Universitaria di Parma

  PRINCIPAL INVESTIGATOR

• Federica Cassè, MD

  Azienda Ospedaliero-Universitaria di Parma

  PRINCIPAL INVESTIGATOR

• Federica Causo, MD

  Azienda Ospedaliero-Universitaria di Parma

  PRINCIPAL INVESTIGATOR

• Jessica Colla, MD

  Azienda Ospedaliero-Universitaria di Parma

  PRINCIPAL INVESTIGATOR

• PierCarlo Cottone, MD

  Azienda Ospedaliero-Universitaria di Parma

  PRINCIPAL INVESTIGATOR

• Marco DiLecce, MD

  Azienda Ospedaliero-Universitaria di Parma

  PRINCIPAL INVESTIGATOR

• Giovanni Gasbarro, MD

  Azienda Ospedaliero-Universitaria di Parma

  PRINCIPAL INVESTIGATOR

• Gelinda Giadone, MD

  Azienda Ospedaliero-Universitaria di Parma

  PRINCIPAL INVESTIGATOR

• Valentina Giampaoli, MD

  Azienda Ospedaliero-Universitaria di Parma

  PRINCIPAL INVESTIGATOR

• Filippo Grandini, MD

  Azienda Ospedaliero-Universitaria di Parma

  PRINCIPAL INVESTIGATOR

• Vera Gualeni, MD

  Azienda Ospedaliero-Universitaria di Parma

  PRINCIPAL INVESTIGATOR

• Alberto Iori, MD

  Azienda Ospedaliero-Universitaria di Parma

  PRINCIPAL INVESTIGATOR

• Marcello LaBombarda, MD

  Azienda Ospedaliero-Universitaria di Parma

  PRINCIPAL INVESTIGATOR

• Cristina Madoni, MD

  Azienda Ospedaliero-Universitaria di Parma

  PRINCIPAL INVESTIGATOR

• Benedetta Marziani, MD

  Azienda Ospedaliero-Universitaria di Parma

  PRINCIPAL INVESTIGATOR

• Cristina Piccinini, MD

  Azienda Ospedaliero-Universitaria di Parma

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elena Giovanna Bignami, Professor of Anesthesiology

CONTACT

+3905211033609; elenagiovanna.bignami@unipr.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Week
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: January 21, 2019
• First Posted: January 28, 2019
• Study Start: February 10, 2019
• Primary Completion: February 10, 2020
• Study Completion: March 10, 2021
• Last Updated: January 30, 2019

Record last verified: 2019-01

Locations

IT (1)