VR Augmented Human Delivered Integrative Psychotherapy for Colonoscopy Procedural Anxiety and Pain
- Conditions
- Procedural PainProcedural Anxiety
- Interventions
- Behavioral: Virtual Reality Integrative PsychotherapyDevice: Virtual Reality Distraction
- Registration Number
- NCT06346171
- Lead Sponsor
- Grigore T. Popa University of Medicine and Pharmacy
- 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.
- 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:
1.1 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; 1.2 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 1.3 VR distraction alone and 1.4 conventional non-sedated colonoscopy
Secondary Aims:
2.1 Evaluate the feasibility and acceptability of implementing VRIP-Col interventions during non-sedated colonoscopy, 2.2 Gathering qualitative feedback from both patients and performing colonoscopists regarding VRIP experienced advantages, obstacles and their perspectives for enhancing the intervention.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 36
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Virtual Reality Integrative Psychotherapy Virtual Reality Distraction This group will undergo the same virtual reality exposure software during the colonoscopy procedure, but the psychotherapist will implement the integrative psychotherapy framework during the procedure. Virtual Reality Integrative Psychotherapy Virtual Reality Integrative Psychotherapy This group will undergo the same virtual reality exposure software during the colonoscopy procedure, but the psychotherapist will implement the integrative psychotherapy framework during the procedure. Virtual Reality Distraction Virtual Reality Distraction This group will be exposed to the virtual reality environment as a distraction, but although receiving support in exploring the virtual world, no psychotherapy techniques will implemented.
- Primary Outcome Measures
Name Time Method Reduction in Procedure-Related Anxiety STAY-Y1: baseline anxiety measured within 20 minutes before the procedure; post-procedural anxiety (within 20 minutes after the procedure's completion). 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.
Pain perception Within 20 minutes before the colonoscopy procedure (baseline) and immediately after the procedure (within 20 minutes post-procedure). 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).
- Secondary Outcome Measures
Name Time Method Feasibility and Acceptability of VRIP-Col Interventions Data on feasibility and acceptability will be collected within 24 hours after the colonoscopy procedure. 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.
Qualitative Feedback on VRIP-Col Interventions Data on feasibility and acceptability will be collected within 24 hours after the colonoscopy procedure. 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.
Trial Locations
- Locations (1)
University of Medicine and Pharmacy Grigore T Popa
🇷🇴Iaşi, Iasi, Romania