Ignite Creation Date:
2024-05-06 @ 11:00 AM
Last Modification Date:
2024-10-26 @ 12:38 PM
Study NCT ID:
NCT03408002
Status:
COMPLETED
Last Update Posted:
2019-06-21
First Post:
2017-07-20
Brief Title:
PREPARE - PREoPerative Anxiety REduction
Sponsor:
Azienda Ospedaliera Universitaria Integrata Verona
Organization:
Azienda Ospedaliera Universitaria Integrata Verona
Study Overview
Official Title:
PREPARE Valutazione di un Intervento Psicologico Pre-operatorio in Pazienti Che Saranno Sottoposti a Chirurgia Del Pancreas
Status:
COMPLETED
Status Verified Date:
2019-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PREPARE
Brief Summary:
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:
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 052 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 patients ability to manage anxiety could increase hisher 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 T0T1T2T3
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
The aim of the present study is to verify if a short individual psychological intervention devoted to improve patients ability to manage anxiety could increase hisher 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 T0T1T2T3
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None