Ignite Creation Date:
2025-12-25 @ 3:55 AM
Ignite Modification Date:
2025-12-26 @ 2:46 AM
Study NCT ID:
NCT03408002
Status:
COMPLETED
Last Update Posted:
2019-06-21
First Post:
2017-07-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
PREPARE - PREoPerative Anxiety REduction
Sponsor:
Azienda Ospedaliera Universitaria Integrata Verona
Organization:
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 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.
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.
Study Oversight
Has Oversight DMC:
False
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?: