Procedural Pain Clinical Trial
— VRIPanx-COLOfficial 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)
Verified date | May 2024 |
Source | Grigore T. Popa University of Medicine and Pharmacy |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Enrolling by invitation |
Enrollment | 36 |
Est. completion date | November 30, 2024 |
Est. primary completion date | August 30, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion criteria: - scheduled non-sedated colonoscopy. - cognitive ability to understand study aims; - willingness to participate and provide written consent. Exclusion criteria: - emergency colonoscopy; - significant sensory-cognitive impairments; - potential risk of: 1. photic seizures; 2. photosensitivity; 3. severe motion sickness; 4. allergies to materials used. - anxiety disorders: 1. use of psychoactive or analgesic substances; 2. concomitant psychotherapy. |
Country | Name | City | State |
---|---|---|---|
Romania | University of Medicine and Pharmacy Grigore T Popa | Iasi | Iasi |
Lead Sponsor | Collaborator |
---|---|
Grigore T. Popa University of Medicine and Pharmacy |
Romania,
Gaina MA, Szalontay AS, Stefanescu G, Balan GG, Ghiciuc CM, Bolos A, Gaina AM, Stefanescu C. State-of-the-Art Review on Immersive Virtual Reality Interventions for Colonoscopy-Induced Anxiety and Pain. J Clin Med. 2022 Mar 17;11(6):1670. doi: 10.3390/jcm11061670. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Trait anxiety | STAI-Y2 will reveal the participants general anxiety in order for a more relevant group matching. Participants general tendency to perceive and respond to situations as threatening or anxiety-inducing. It will be applied after enrolling. | Within 72 hours after study enrolment. | |
Other | Quality of Life impact VRIP-Col | Assessment of the bio-psycho-social interplay of VRIP as reflected by the score dynamic of the Health, Self-Esteem, relationships and Goals and Values items assessed by a qualified researcher using a Romanian population-standardised Quality of Life Inventory. | Within 36 hours before and after the colonoscopy procedure. | |
Primary | Reduction in Procedure-Related Anxiety | This measure assesses the degree of reduction in anxiety related to undergoing a non-sedated colonoscopy procedure. Anxiety levels will be quantified using the Spielberger STAI-Y1 and STAI-Y2 forms, previously standardized to the Romanian population and approved by Romanian Psychological College. STAI-Y1 and Y2 are applied and interpreted by a licensed investigator, in order to ensure viability of collected data. The scale measures how respondents feel at a particular moment in time and in general, providing insight into both state and trait anxiety levels. The difference in STAI-Y1 scores from baseline (pre-intervention) to post-procedure will be analyzed to determine the effectiveness of the VR-Augmented Integrative Psychotherapy in reducing procedural anxiety compared to Sham VR Distraction and control groups. | STAY-Y1: baseline anxiety measured within 20 minutes before the procedure; post-procedural anxiety (within 20 minutes after the procedure's completion). | |
Primary | Pain perception | The primary measure of pain perception will be the Visual Analog Scale (VAS), a validated tool for pain assessment. This self-reported measure allows patients to rate their pain on a scale from "no pain" (0) to "worst imaginable pain" (10). | Within 20 minutes before the colonoscopy procedure (baseline) and immediately after the procedure (within 20 minutes post-procedure). | |
Secondary | Feasibility and Acceptability of VRIP-Col Interventions | This outcome will assess the logistical feasibility and overall acceptability of the VRIP-Col interventions among patients undergoing non-sedated colonoscopy. Feasibility metrics will include the successful integration of VRIP-Col into clinical workflows, the ability to deliver the intervention to all enrolled participants without disrupting standard care procedures, and the technical reliability of VR equipment. Acceptability will be evaluated through patient and healthcare provider satisfaction surveys, focusing on the perceived usefulness, ease of use, and willingness to use or recommend the VRIP-Col interventions in the future. | Data on feasibility and acceptability will be collected within 24 hours after the colonoscopy procedure. | |
Secondary | Qualitative Feedback on VRIP-Col Interventions | This outcome will involve the collection and analysis of qualitative feedback from patients who receive the VRIP-Col interventions and the colonoscopists who perform the procedures. Feedback will be gathered through semi-structured interviews designed to explore the perceived advantages of the VRIP-Col interventions, any obstacles encountered during their implementation, and suggestions for improvement from both the patient and provider perspectives. This qualitative analysis will provide insights into the user experience, identify potential barriers to effective implementation, and inform future refinements of the VRIP-Col approach. | Data on feasibility and acceptability will be collected within 24 hours after the colonoscopy procedure. |
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