An interventional study of Psychological intervention in Anxiety Disorder and Surgery, sponsored by Azienda Ospedaliera Universitaria Integrata Verona. Completed at 1 site in Italy. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-06-21.
Sponsored by Azienda Ospedaliera Universitaria Integrata Verona · Not applicable, Interventional, and Prevention
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Among 94 studies in Anxiety Disorders with a site in Italy — 29 open to participants now, 31 under way, none of them phase 3. Anxiety Disorders · Italy.
Among the 94 studies in Anxiety Disorders with a site in Italy, this one is the 6th largest by enrollment of the 64 interventional ones that give a count, is the only one that started in 2017, is one of 54 with no phase, and was the 19th registered.
7,207 studies on the registry are indexed under Anxiety Disorders; 1,682 are open to participants now.
Browse Anxiety Disorders studies →29 of the 94 studies in Anxiety Disorders with a site in Italy are open now. Recruiting first, the newest first:
Istituto Oncologico Veneto IRCCS · Sites in Italy
Ages 18–99
IRCCS Centro Neurolesi Bonino Pulejo · Sites in Italy
Ages 18–60
Istituti Clinici Scientifici Maugeri SpA · Sites in Italy
Ages 18+
Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria · Sites in Italy
Ages 3–17 · Healthy volunteers
Università degli Studi del Piemonte Orientale Amedeo Avogadro · Sites in Italy
Ages 18+
A study can be open while its sites in Italy have not opened yet or have stopped. Only those recruiting at a site in Italy →
Of the 944 Anxiety Disorders studies recruiting now, 417 (44%) set no upper age limit and 460 (49%) stop at 75 or younger; 233 take children under 18; 317 take healthy volunteers.
This study: 18 Years to 80 Years · all sexes · no healthy volunteers.
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94 studies; the count open now beside each. This study's row is marked.
First in 2001; this study’s year is marked. 1 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 400 is above the median of 80 across 6,062 interventional studies indexed under Anxiety Disorders.
Median enrollment 83 across the 64 interventional studies, 155 across the 30 observational. Of the 54 that completed or were terminated, 2 (4%) have results posted.
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7 of 94 have an industry lead sponsor. The 10 most frequent:
Azienda Ospedaliera Universitaria Integrata Verona is the lead sponsor of 95 studies on the registry; 18 are open to participants now.
Azienda Ospedaliera Universitaria Integrata Verona has 1 study filed under Anxiety Disorders — fewer than ten, so there is no comparison to draw.
6 of the studies in Anxiety Disorders with a site in Italy that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06906003Fondazione G.B. Bietti, IRCCSVisual Rehabilitation and Depression in Visually Impaired Patients With AMD | 2026-12-02 |
| NCT07502807Liaquat University of Medical & Health SciencesEffect of Neurofast® Supplementation on Anxiety and Cardiovascular Outcomes in the Psycho-Cardio Phenotype Adults | 2026-12-31 |
| NCT07338292Istituto Oncologico Veneto IRCCSVIrtual Reality Induced Pain and anxiEty Relief in Outpatient UROlogical Procedures | 2026-12-31 |
| NCT07686029Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di AlessandriaUse of Maltodextrins in the ERAS Preoperative Fasting Protocol in Pediatric Surgery | 2027-05 |
| NCT07424209Università degli Studi del Piemonte Orientale Amedeo AvogadroHypnotic Communication in Cardiology: A Randomized Controlled Trial | 2027-06-09 |
Add all 6 to your calendar (.ics) → With an account.
Among the 94 studies in Anxiety Disorders with a site in Italy, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
no 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
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".
Time frame: 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).
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.
Time frame: 3rd day after surgery
Number of perioperative complications
Description of the number and type of post-operative complications
Time frame: 30 days
Number of days of hospitalization
Exact number of hospitalization days for each patient
Time frame: 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.
Time frame: from the 3rd day until 5th day after surgery
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
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: Collection during psychological intervention (which lasts on average one hour), after collecting 4 minutes of baseline.
Ran from Jun 2017 to primary completion in Jun 2018, 12 months.
Of 3,841 non-industry interventional studies with no phase under Anxiety Disorders, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 28. This study's 12 months is close to that.
Counting every sponsor, half of 3,943 studies reached it within 12 months; a quarter within 5 and three quarters within 28.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.
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Azienda Ospedaliera Universitaria Integrata Verona