Clinical trial NCT03408002: PREPARE - PREoPerative Anxiety REduction
Official title: PREPARE: Valutazione di un Intervento Psicologico Pre-operatorio in Pazienti Che Saranno Sottoposti a Chirurgia Del Pancreas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety Disorder
Surgery
Keywords: preoperative anxiety
self-efficacy
psychophysiology
psychotherapy
pancreatic surgery
Lead sponsor: Azienda Ospedaliera Universitaria Integrata Verona
Sponsor class: OTHER
Collaborators: name: University of Pisa
name: Universita di Verona
First posted: 2018-01-23
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 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 outcomes:
measure: Post-operative pain measured by the Brief Pain Inventory
timeFrame: 3rd day after surgery
measure: Number of perioperative complications
timeFrame: 30 days
measure: Number of days of hospitalization
timeFrame: 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.
measure: VAS-P Visual Analogue Scale of Pain.
timeFrame: from the 3rd day until 5th day after surgery
Other outcomes:
measure: Preoperative Anxiety comparing the score before (baseline) and after the psychological intervention in the experimental group and only at baseline in the control group.
timeFrame: Preoperative Anxiety 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).
measure: Change of state anxiety, comparing the score before (baseline) and after the psychological intervention in the experimental group and only at baseline in the control group.
timeFrame: State anxiety 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).
measure: WAI-T, Therapist version of Working Alliance Inventory (Only experimental group)
timeFrame: Immediately after the conclusion of the psychological intervention (up to 1 hour)
measure: WAI-C, Client version of Working Alliance Inventory (Only experimental group)
timeFrame: Immediately after the conclusion of the psychological intervention (up to 1 hour)
measure: Electrodermal activity (Only experimental group patients without jaundice, feverish states, pancreatic pain with analgesic therapy, recent neoadjuvant therapy, psychotropic therapy or cardio-vascular problems will be included)
timeFrame: Collection during psychological intervention (which lasts on average one hour), after collecting 4 minutes of baseline.
measure: Heart Rate Variability (HRV) (Only experimental group patients without jaundice, feverish states, pancreatic pain with analgesic therapy, recent neoadjuvant therapy, psychotropic therapy or cardio-vascular problems will be included)
timeFrame: Collection during psychological intervention (which lasts on average one hour), after collecting 4 minutes of baseline.
Locations:
city: Verona
country: Italy
facility: Azienda Ospedaliera Universitaria Integrata
Study officials:
affiliation: Azienda Ospedaliera Universitaria Integrata
name: Lidia Del Piccolo
role: PRINCIPAL_INVESTIGATOR
References:
citation: Marinelli V, Danzi OP, Mazzi MA, Secchettin E, Tuveri M, Bonamini D, Rimondini M, Salvia R, Bassi C, Del Piccolo L. PREPARE: PreoPerative Anxiety REduction. One-Year Feasibility RCT on a Brief Psychological Intervention for Pancreatic Cancer Patients Prior to Major Surgery. Front Psychol. 2020 Mar 5;11:362. doi: 10.3389/fpsyg.2020.00362. eCollection 2020.