PREPARE - PREoPerative Anxiety REduction

Study Overview
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Brief Summary
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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.

Detailed Description
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Patients who have to undergo surgery experience multiple sources of stress. A recent narrative review carried out on 115 studies by Powell et al. (2016) reported different and inconsistent findings on the relation between psychological interventions and surgery outcomes, due to the heterogeneity of these interventions, mainly based on information giving and patient education, and the very different samples of patients considered. Some evidences showed that pre-operative psychological interventions may contribute to reduce post-operative pain, duration of hospital stay (mean difference of 0.52 days) and negative affect. No studies were conducted with patients who had to undergo pancreatic surgery nor specific psychological interventions were devoted to increase self-efficacy in managing anxiety. The aim of the present study is to verify if a short individual psychological intervention devoted to improve patient's ability to manage anxiety could increase his/her confidence to cope with pancreatic surgery, either in terms of perceived self-efficacy (main outcome) or less state anxiety reported on STAI-Y1 scale. Post-surgery outcomes are also collected: pain reported during the days following surgical intervention, length of hospital stay and number and type of clinical complications. The study will involve 400 patients randomly divided in two arms and it is organized in four phases: T0,T1,T2,T3. T0: Once obtained the informed consent, demographic information will be collected using a structured questionnaire. Clinical variables will be collected by self-administered tools, for which patients can ask support, if needed. T1: The day before surgery, all patients will indicate their perceived self-efficacy in managing anxiety and will fulfil specific anxiety scales. T2: after randomization, patients in the experimental group will participate to the psychological intervention, whereas the control group will follow usual care. T3: After surgery pain, length of hospital stay and the number of post-operative complications within 30 days will be evaluated as secondary outcomes on all patients.

Official Title
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PREPARE: Valutazione di un Intervento Psicologico Pre-operatorio in Pazienti Che Saranno Sottoposti a Chirurgia Del Pancreas

Conditions
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Anxiety Disorder, Surgery

Intervention / Treatment
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* Behavioral: Psychological intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control group<br>no intervention | |
| Experimental: Psychological intervention<br>Psychological intervention using the Four elements technique elaborated by Shapiro and reported in M. Luber (2009) during a psychological consultation conducted the day before surgery. | Behavioral: Psychological intervention<br>* The intervention aims to increase self-efficacy perception in managing pre-operative anxiety. The intervention is based on one single psychological consultation adopting the Four elements technique elaborated by Shapiro<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Number of perioperative complications | Description of the number and type of post-operative complications | 30 days | 
| 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. | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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preoperative anxiety, self-efficacy, psychophysiology, psychotherapy, pancreatic surgery