Surgery Clinical Trial
— PREPAREOfficial title:
PREPARE: Valutazione di un Intervento Psicologico Pre-operatorio in Pazienti Che Saranno Sottoposti a Chirurgia Del Pancreas
Verified date | June 2019 |
Source | Azienda Ospedaliera Universitaria Integrata Verona |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The study aims to verify if a short individual psychological intervention might increase perceived self-efficacy in managing preoperative anxiety in patients who will undergo pancreatic surgery. It is a randomized clinical trial where half of participants will attend a psychological intervention based on "the four elements protocol" by Elan Shapiro the day before surgery, while the other half will follow usual care.
Status | Completed |
Enrollment | 400 |
Est. completion date | December 30, 2018 |
Est. primary completion date | June 15, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - 18 - 80 years old - cognitively able to give personal consent to participate to the study - to be scheduled to have general anaesthesia for pancreatic surgery Exclusion Criteria: - age under 18 years and over 80 years - cognitively unable to give personal consent to participate to the study - postponement of surgical operation |
Country | Name | City | State |
---|---|---|---|
Italy | Azienda Ospedaliera Universitaria Integrata | Verona |
Lead Sponsor | Collaborator |
---|---|
Azienda Ospedaliera Universitaria Integrata Verona | Universita di Verona, University of Pisa |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Preoperative Anxiety comparing the score before (baseline) and after the psychological intervention in the experimental group and only at baseline in the control group. | Amsterdam Preoperative Anxiety and Information Scale (APAIS) is a Likert (scoring from 1="not at all" to 5="completely agree") 6 item scale | Preoperative Anxiety will be measured before (baseline) and immediately after the psychological intervention (up to 1 hour) in the experimental group, whereas in the control group it will be measured only once (baseline). | |
Other | Change of state anxiety, comparing the score before (baseline) and after the psychological intervention in the experimental group and only at baseline in the control group. | State-Trait Anxiety Inventory (STAI-Y1) | State anxiety will be measured before (baseline) and immediately after the psychological intervention (up to 1 hour) in the experimental group, whereas in the control group it will be measured only once (baseline). | |
Other | WAI-T, Therapist version of Working Alliance Inventory (Only experimental group) | WAI-T is a 36-item Likert scale on 7 points. There is no cut-off. Higher values indicate a better outcome. | Immediately after the conclusion of the psychological intervention (up to 1 hour) | |
Other | WAI-C, Client version of Working Alliance Inventory (Only experimental group) | WAI-C is a 36-item Likert scale on 7 points.There is no cut-off. Higher values indicate a better outcome. | Immediately after the conclusion of the psychological intervention (up to 1 hour) | |
Other | Electrodermal activity (Only experimental group patients without jaundice, feverish states, pancreatic pain with analgesic therapy, recent neoadjuvant therapy, psychotropic therapy or cardio-vascular problems will be included) | Skin Conductance Level (SCL) measured in microsiemens (µS), using the Biopac MP150 system, which is connected to a Windows 7 operated computer running Acknowledge 4.1 data acquisition program and Observer XT 10.0 (Noldus). | Collection during psychological intervention (which lasts on average one hour), after collecting 4 minutes of baseline. | |
Other | Heart Rate Variability (HRV) (Only experimental group patients without jaundice, feverish states, pancreatic pain with analgesic therapy, recent neoadjuvant therapy, psychotropic therapy or cardio-vascular problems will be included) | Beat-to-beat variation of heart rate over time. ECG signals will be recorded by means of ECG100C Electrocardiogram Amplifier from BIOPAC MP150 system, with a sampling rate of 500 Hz. BIOPAC is connected to a Windows 7 operated computer running Acknowledge 4.1 data acquisition program and Observer XT 10.0 (Noldus). | Collection during psychological intervention (which lasts on average one hour), after collecting 4 minutes of baseline. | |
Primary | Change of Perceived self-efficacy, comparing the score on analogue scale (range 1-10) before (baseline) and after the psychological intervention in the experimental group. | To measure perceived self-efficacy, patients respond to the following question: "We kindly ask you to indicate on a scale from 1 to 10 how much you perceive to be able to manage anxiety before the surgery". | Perceived self-efficacy will be measured before (baseline) and immediately after the psychological intervention (up to 1 hour) in the experimental group, whereas in the control group it will be measured only once (baseline). | |
Secondary | Post-operative pain measured by the Brief Pain Inventory | It is a brief questionnaire composed which evaluates the intensity of perceived pain during the last 24 hours. The patient indicates on a human figure where is located the pain and its intensity on an analogue scale (range 1-10), then the patient responds to seven questions asking how this pain interferes with general activities, work, mood, ability to walk, quality of slumber and social relationships. | 3rd day after surgery | |
Secondary | Number of perioperative complications | Description of the number and type of post-operative complications | 30 days | |
Secondary | Number of days of hospitalization | Exact number of hospitalization days for each patient | From date of hospital admission until the date of discharge or date of death from any cause, whichever came first, assessed up to 6 months. | |
Secondary | VAS-P Visual Analogue Scale of Pain. | VAS-P is a visual analogue scale where number 0 represents "absence of pain" and number 10 indicates "the worse pain ever tried". To measure perceived postoperative pain, patients respond to the following question: "We kindly ask you to indicate on a scale from 0 to 10 the intensity of your pain".The scale has no standardized scores or cut-off. Each patient applies his or her own "yardstick" in answering questions. Lower values are considered a better outcome. | from the 3rd day until 5th day after surgery |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05583916 -
Same Day Discharge for Video-Assisted Thoracoscopic Surgery (VATS) Lung Surgery
|
N/A | |
Completed |
NCT04448041 -
CRANE Feasibility Study: Nutritional Intervention for Patients Undergoing Cancer Surgery in Low- and Middle-Income Countries
|
||
Completed |
NCT03213314 -
HepaT1ca: Quantifying Liver Health in Surgical Candidates for Liver Malignancies
|
N/A | |
Enrolling by invitation |
NCT05534490 -
Surgery and Functionality in Older Adults
|
N/A | |
Recruiting |
NCT04792983 -
Cognition and the Immunology of Postoperative Outcomes
|
||
Terminated |
NCT04612491 -
Pre-operative Consultation on Patient Anxiety and First-time Mohs Micrographic Surgery
|
||
Recruiting |
NCT06397287 -
PROM Project Urology
|
||
Recruiting |
NCT04444544 -
Quality of Life and High-Risk Abdominal Cancer Surgery
|
||
Completed |
NCT04204785 -
Noise in the OR at Induction: Patient and Anesthesiologists Perceptions
|
N/A | |
Completed |
NCT03432429 -
Real Time Tissue Characterisation Using Mass Spectrometry REI-EXCISE iKnife Study
|
||
Completed |
NCT04176822 -
Designing Animated Movie for Preoperative Period
|
N/A | |
Recruiting |
NCT05370404 -
Prescribing vs. Recommending Over-The-Counter (PROTECT) Analgesics for Patients With Postoperative Pain:
|
N/A | |
Not yet recruiting |
NCT05467319 -
Ferric Derisomaltose/Iron Isomaltoside and Outcomes in the Recovery of Gynecologic Oncology ERAS
|
Phase 3 | |
Recruiting |
NCT04602429 -
Children's Acute Surgical Abdomen Programme
|
||
Completed |
NCT03124901 -
Accuracy of Noninvasive Pulse Oximeter Measurement of Hemoglobin for Rainbow DCI Sensor
|
N/A | |
Completed |
NCT04595695 -
The Effect of Clear Masks in Improving Patient Relationships
|
N/A | |
Recruiting |
NCT06103136 -
Maestro 1.0 Post-Market Registry
|
||
Completed |
NCT05346588 -
THRIVE Feasibility Trial
|
Phase 3 | |
Completed |
NCT04059328 -
Novel Surgical Checklists for Gynecologic Laparoscopy in Haiti
|
||
Recruiting |
NCT03697278 -
Monitoring Postoperative Patient-controlled Analgesia (PCA)
|
N/A |