VALUTAZIONE DI UN INTERVENTO PSICOLOGICO PRE-OPERATORIO IN PAZIENTI CHE SARANNO SOTTOPOSTI A CHIRURGIA DEL PANCREAS. Un studio sperimentale senza farmaco né dispositivo, randomizzato, controllato

Starting date
July 4, 2017
Duration (months)
16
Departments
Neurosciences, Biomedicine and Movement Sciences
Managers or local contacts
Del Piccolo Lidia

Methods and analysis: All patients listed for pancreatic major surgery, once provided the informed consent to participate to the study, are assigned randomly to the psychological intervention or to the control group. The preoperative psychological intervention provides the patient the opportunity to talk with a psychologist about personal concerns and to learn simple techniques to cope with stress.
Ethics and dissemination. The study was approved by the local Ethics Committee of the Hospital Introduction: Patients who have to undergo surgical procedures experience high levels of stress due to uncertainty, concern and worry related to the potential physical and mental damage of surgery. Psychological interventions devoted to help patients to deal with these concerns are described in literature, but they are heterogeneous, mainly based on information giving and patient education, or sometimes on the use of relaxation or mindfulness techniques, and are conducted in different settings, making difficult to compare results.
The aim of the present paper is to describe the protocol of a study designed to verify if a short individual psychological intervention can improve patients’ self-efficacy in managing anxiety and their confidence in coping with pancreatic surgery (main outcome). Secondary outcomes are the lowering of “state” anxiety after the psychological intervention and its positive consequences after surgery in terms of: reduction of the number of hospitalization days, the pain perception and the number of complications after surgery.
Trust of Verona. Study findings will be disseminated through peer-reviewed publications and conference presentations.
Registration details. Protocol version 1, 12th April 2017 Prog. 1288CESC
Trial registration: ClinicalTrials.gov identifier: NCT03408002

Sponsors:

Funds: assigned and managed by the department

Project participants

Maria Angela Mazzi
Technical-administrative staff
Michela Rimondini
Associate Professor
Roberto Salvia
Full Professor

Collaboratori esterni

Massimiliano Tuveri
University Hospital of Verona
Ronaldo Rouvher Guedes Silva
University Hospital of Verona

Activities

Research facilities