PREPARE - PREoPerative Anxiety REduction (PREPARE)

PREPARE: Valutazione di un Intervento Psicologico Pre-operatorio in Pazienti Che Saranno Sottoposti a Chirurgia Del Pancreas

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.

Study Overview

• Status: Completed
• Conditions: Surgery; Anxiety Disorder
• Intervention / Treatment: Behavioral: Psychological intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 400
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Verona, Italy, 37122
    • Azienda Ospedaliera Universitaria integrata

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: control group; no intervention
Experimental: Psychological intervention; Psychological intervention using the "Four elements" technique elaborated by Shapiro and reported in M. Luber (2009) during a psychological consultation conducted the day before surgery.	Behavioral: Psychological intervention; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	To measure perceived self-efficacy, patients respond to the following question: "We kindly ask you to indicate on a scale from 1 to 10 how much you perceive to be able to manage anxiety before the surgery".	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-operative pain measured by the Brief Pain Inventory	It is a brief questionnaire composed which evaluates the intensity of perceived pain during the last 24 hours. The patient indicates on a human figure where is located the pain and its intensity on an analogue scale (range 1-10), then the patient responds to seven questions asking how this pain interferes with general activities, work, mood, ability to walk, quality of slumber and social relationships.	3rd day after surgery
Number of perioperative complications	Description of the number and type of post-operative complications	30 days
Number of days of hospitalization	Exact number of hospitalization days for each patient	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.
VAS-P Visual Analogue Scale of Pain.	VAS-P is a visual analogue scale where number 0 represents "absence of pain" and number 10 indicates "the worse pain ever tried". To measure perceived postoperative pain, patients respond to the following question: "We kindly ask you to indicate on a scale from 0 to 10 the intensity of your pain".The scale has no standardized scores or cut-off. Each patient applies his or her own "yardstick" in answering questions. Lower values are considered a better outcome.	from the 3rd day until 5th day after surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Preoperative Anxiety comparing the score before (baseline) and after the psychological intervention in the experimental group and only at baseline in the control group.	Amsterdam Preoperative Anxiety and Information Scale (APAIS) is a Likert (scoring from 1="not at all" to 5="completely agree") 6 item scale	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).
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.	State-Trait Anxiety Inventory (STAI-Y1)	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).
WAI-T, Therapist version of Working Alliance Inventory (Only experimental group)	WAI-T is a 36-item Likert scale on 7 points. There is no cut-off. Higher values indicate a better outcome.	Immediately after the conclusion of the psychological intervention (up to 1 hour)
WAI-C, Client version of Working Alliance Inventory (Only experimental group)	WAI-C is a 36-item Likert scale on 7 points.There is no cut-off. Higher values indicate a better outcome.	Immediately after the conclusion of the psychological intervention (up to 1 hour)
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)	Skin Conductance Level (SCL) measured in microsiemens (μS), using the Biopac MP150 system, which is connected to a Windows 7 operated computer running Acknowledge 4.1 data acquisition program and Observer XT 10.0 (Noldus).	Collection during psychological intervention (which lasts on average one hour), after collecting 4 minutes of baseline.
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)	Beat-to-beat variation of heart rate over time. ECG signals will be recorded by means of ECG100C Electrocardiogram Amplifier from BIOPAC MP150 system, with a sampling rate of 500 Hz. BIOPAC is connected to a Windows 7 operated computer running Acknowledge 4.1 data acquisition program and Observer XT 10.0 (Noldus).	Collection during psychological intervention (which lasts on average one hour), after collecting 4 minutes of baseline.

Collaborators and Investigators

• Sponsor: Azienda Ospedaliera Universitaria Integrata Verona
• Collaborators: University of Pisa; Universita di Verona
• Investigators: Principal Investigator: Lidia Del Piccolo, Azienda Ospedaliera Universitaria integrata

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 14, 2017
• Primary Completion (Actual): June 15, 2018
• Study Completion (Actual): December 30, 2018

Study Registration Dates

• First Submitted: July 20, 2017
• First Submitted That Met QC Criteria: January 17, 2018
• First Posted (Actual): January 23, 2018

Study Record Updates

• Last Update Posted (Actual): June 21, 2019
• Last Update Submitted That Met QC Criteria: June 20, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: pancreatic surgery; psychotherapy; psychophysiology; self-efficacy; preoperative anxiety
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: Prog. 1288CESC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No