PREPARE - PREoPerative Anxiety REduction

NCT03408002 | Completed

• 1 other identifier: Prog. 1288CESC
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety Disorder; Surgery

Keywords

preoperative anxiety; self-efficacy; psychophysiology; psychotherapy; pancreatic surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Post-operative pain measured by the Brief Pain Inventory

  3rd day after surgery

• Number of perioperative complications

  30 days

• Number of days of hospitalization

  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.

  from the 3rd day until 5th day after surgery

Other Outcomes (6)

• Preoperative Anxiety comparing the score before (baseline) and after the psychological intervention in the experimental group and only at baseline in the control group.

  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 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)

  Immediately after the conclusion of the psychological intervention (up to 1 hour)

Study Arms (2)

control group

NO INTERVENTION

no intervention

Psychological intervention

EXPERIMENTAL

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

Interventions

Psychological intervention BEHAVIORAL

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

Psychological intervention

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old
• cognitively able to give personal consent to participate to the study
• to be scheduled to have general anaesthesia for pancreatic surgery

You may not qualify if:

• age under 18 years and over 80 years
• cognitively unable to give personal consent to participate to the study
• postponement of surgical operation

Sponsors & Collaborators

• Azienda Ospedaliera Universitaria Integrata Verona: lead
• University of Pisa: collaborator
• Universita di Verona: collaborator

Study Sites (1)

Azienda Ospedaliera Universitaria Integrata

Verona, 37122, Italy

Location

Related Publications (1)

• 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.

  PMID: 32194490 DERIVED

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Psychosocial Intervention

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Lidia Del Piccolo

  Azienda Ospedaliera Universitaria Integrata

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 20, 2017
• First Posted: January 23, 2018
• Study Start: June 14, 2017
• Primary Completion: June 15, 2018
• Study Completion: December 30, 2018
• Last Updated: June 21, 2019

Record last verified: 2019-06

Locations

IT (1)