Ignite Creation Date:
2024-05-06 @ 2:18 AM
Last Modification Date:
2024-10-26 @ 11:16 AM
Study NCT ID:
NCT02018471
Status:
COMPLETED
Last Update Posted:
2013-12-23
First Post:
2013-12-17
Brief Title:
Psychological Counselling in Diagnostic Screening
Sponsor:
Istituto Oncologico Veneto IRCCS
Organization:
Istituto Oncologico Veneto IRCCS
Study Overview
Official Title:
Management of Anxiety Related to Diagnostic Screenings an Exploratory Pilot Study
Status:
COMPLETED
Status Verified Date:
2013-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Diagnostic tests have a deep emotional impact on oncology patients Anxiety and worries can lead people to avoid screening tests with high risks for health A single arm pilot study was organized to evaluate the feasibility and efficacy of psychological counselling for cancer patients who demonstrated anxiety for diagnostic tests The hypothesis was that taking part in Psychoeducative Training could offer a new modality to reduce anxiety before and during tests and also the possibility to reinforce coping strategies
Detailed Description:
The Psychoeducative Training was organized in 6 weekly meetings lasting two hours Each group was composed of 6 participants The Training follows the cognitive-behavioural model In the first part of every meeting theoretical aspects about stress and anxiety were explained while in the second part some relaxation techniques were taught During relaxation we used a selected music that was also going to be used during the diagnostic tests Since the first meeting patients experienced these relaxing techniques in order to learn them In order to support the adaptability at the end of every meeting the participants received some homework They had to take notes on how many times they repeated the relaxation exercises and on the anxiety level before and after the training
For the study 43 people were recruited Anxiety was measured with Beck Anxiety Inventory BAI it values the seriousness of the physiological behaviour connected with anxiety This test an anxiety gauge which allows us to obtain numerical data on emotional changes The test is composed of 4 interpretative levels serious moderate small and minimal anxiety
The coping style was measured with Coping Orientation to Problems Experienced-New Italian Version COPE-NIV this test evaluates the way in which people resolve and face traumatic or usual stressful situations
The research project was approved by the Ethics Committee of Veneto Institute of Oncology
Every patient signed a written informed consent to process the data for research purposes and to publish it
Forty-three patients who had to undergo one or more diagnostic tests PET TAC fMRI Mammography Endoscopy Colonoscopy took part in the study The average age was 524 and 615 were married
For the study 43 people were recruited Anxiety was measured with Beck Anxiety Inventory BAI it values the seriousness of the physiological behaviour connected with anxiety This test an anxiety gauge which allows us to obtain numerical data on emotional changes The test is composed of 4 interpretative levels serious moderate small and minimal anxiety
The coping style was measured with Coping Orientation to Problems Experienced-New Italian Version COPE-NIV this test evaluates the way in which people resolve and face traumatic or usual stressful situations
The research project was approved by the Ethics Committee of Veneto Institute of Oncology
Every patient signed a written informed consent to process the data for research purposes and to publish it
Forty-three patients who had to undergo one or more diagnostic tests PET TAC fMRI Mammography Endoscopy Colonoscopy took part in the study The average age was 524 and 615 were married
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None