Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06346171
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-05-29
First Post:
2024-03-28
Brief Title:
VR Augmented Human Delivered Integrative Psychotherapy for Colonoscopy Procedural Anxiety and Pain
Sponsor:
Grigore T Popa University of Medicine and Pharmacy
Organization:
Grigore T Popa University of Medicine and Pharmacy
Study Overview
Official Title:
Evaluating a Virtual Reality Augmented Clinician-Delivered Integrative Psychotherapy Model for Non-Sedated Colonoscopy Procedural Anxiety and Pain A Prevalidation Trial Protocol VRIPanx-COL
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-05
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:
VRIPanx-COL
Brief Summary:
Colonoscopy is an invaluable tool for the diagnosis and management of colon diseases especially colorectal cancer CRC - the third most common cancer worldwide Its unmatched ability to detect CRC and premalignant growths makes it the gold standard however it is not without its challenges Patients often experience pre-procedure anxiety and discomfort primarily related to anticipated pain which negatively impacts both the procedure and its outcomes
Colonoscopy procedural anxiety not only exacerbates the experience of pain but also may compromise the quality of bowel preparation augment procedure and recovery room times and increase the use of sedation particularly among females who report greater pre-procedural anxiety and perceive the procedure to be more painful and harder to endure This underscores the importance of interventions aimed at mitigating anxiety to improve patient experience and adherence to colonoscopy procedures
The profound positive corelation between anxiety and pain impact on outcomes of colonoscopy warrants an investigation of comprehensive patient care strategies A growing body of evidence indicates that non-pharmacologic interventions such as music therapy and immersive virtual reality iVR may effectively reduce anxiety pain and enhance overall patient satisfaction
Understanding barriers to colonoscopy compliance such as fear of cancer diagnosis the perception of invasiveness and feelings of embarrassment is paramount to enhancing CRC screening uptake therefore lowering mortality
Colonoscopy procedural anxiety not only exacerbates the experience of pain but also may compromise the quality of bowel preparation augment procedure and recovery room times and increase the use of sedation particularly among females who report greater pre-procedural anxiety and perceive the procedure to be more painful and harder to endure This underscores the importance of interventions aimed at mitigating anxiety to improve patient experience and adherence to colonoscopy procedures
The profound positive corelation between anxiety and pain impact on outcomes of colonoscopy warrants an investigation of comprehensive patient care strategies A growing body of evidence indicates that non-pharmacologic interventions such as music therapy and immersive virtual reality iVR may effectively reduce anxiety pain and enhance overall patient satisfaction
Understanding barriers to colonoscopy compliance such as fear of cancer diagnosis the perception of invasiveness and feelings of embarrassment is paramount to enhancing CRC screening uptake therefore lowering mortality
Detailed Description:
The proposed VR-Facilitated Integrative Psychotherapy framework VRIPainX-COL leverages the immersive capabilities of VR as platform fir psychological interventions for this pilot trial is designed to assess its preliminary efficacy acceptability and feasibility in reducing the pre-procedural anxiety and discomfort associated with colonoscopy
Primary Aims
11 Developing a comprehensive conceptual framework for colonoscopy procedural anxiety and pain reduction through a a humanised digital interface using virtual reality distraction as platform for integrative psychotherapy support VRIPanx-COL 12 Clinically implementing the VRIPanx-COL blueprint within a methodological design aimed at assessing its preliminary efficacy in reducing perceived procedural anxiety and pain compared to 13 VR distraction alone and 14 conventional non-sedated colonoscopy
Secondary Aims
21 Evaluate the feasibility and acceptability of implementing VRIP-Col interventions during non-sedated colonoscopy 22 Gathering qualitative feedback from both patients and performing colonoscopists regarding VRIP experienced advantages obstacles and their perspectives for enhancing the intervention
Primary Aims
11 Developing a comprehensive conceptual framework for colonoscopy procedural anxiety and pain reduction through a a humanised digital interface using virtual reality distraction as platform for integrative psychotherapy support VRIPanx-COL 12 Clinically implementing the VRIPanx-COL blueprint within a methodological design aimed at assessing its preliminary efficacy in reducing perceived procedural anxiety and pain compared to 13 VR distraction alone and 14 conventional non-sedated colonoscopy
Secondary Aims
21 Evaluate the feasibility and acceptability of implementing VRIP-Col interventions during non-sedated colonoscopy 22 Gathering qualitative feedback from both patients and performing colonoscopists regarding VRIP experienced advantages obstacles and their perspectives for enhancing the intervention
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None