PREPARE - PREoPerative Anxiety REduction
Condition: Anxiety Disorder; Surgery
MeSH terms: Anxiety Disorders
Study type: Interventional

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.
    

Intervention name(s): Psychological intervention
Intervention type(s): Behavioral
Intervention description(s): 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
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: preoperative anxiety; self-efficacy; psychophysiology; psychotherapy; pancreatic surgery