Evaluating a Virtual Reality Augmented Clinician-Delivered Integrative Psychotherapy Model for Non-Sedated Colonoscopy Procedural Anxiety and Pain: A Prevalidation Trial Protocol (VRIPanx-COL)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Enrollment
- 36
- Locations
- 2
- Primary Endpoint
- Reduction in Procedure-Related Anxiety
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description
To ensure credible outcomes, robust blinding for participants, care providers, and outcome assessors is vital to minimize bias. Participants will be briefed generally about participating in VR distraction research, with no details on psychotherapy inclusion. Gastroenterologists and outcome assessors remain blinded to intervention types, using standard tools for unbiased outcome evaluation. The principal investigator, aware of the intervention nature, conducts psychotherapy sessions or engages in simple discussion for control arm VR exposure. Another gastroenterologist oversees randomization to maintain blinding. Standardized VR distractions and pre-programmed randomization ensure unbiased participant allocation, reinforcing study validity through meticulous concealment and blinding protocols.
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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:
- •photic seizures;
- •photosensitivity;
- •severe motion sickness;
- •allergies to materials used.
- •anxiety disorders:
- •use of psychoactive or analgesic substances;
- •concomitant psychotherapy.
Arms & Interventions
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.
Intervention: Virtual Reality Distraction (Device)
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.
Intervention: Virtual Reality Integrative Psychotherapy (Behavioral)
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.
Intervention: Virtual Reality Distraction (Device)
Control group
This group will undergo treatment as usual according to state-of-the-art guidelines for non-sedated colonoscopy.
Outcomes
Primary Outcomes
Reduction in Procedure-Related Anxiety
Time Frame: 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
Time Frame: 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 Outcomes
- Feasibility and Acceptability of VRIP-Col Interventions(Data on feasibility and acceptability will be collected within 24 hours after the colonoscopy procedure.)
- Qualitative Feedback on VRIP-Col Interventions(Data on feasibility and acceptability will be collected within 24 hours after the colonoscopy procedure.)
Investigators
Marcel-Alexandru Gaina
MD assist prof Marcel-Alexandru Gaina
Grigore T. Popa University of Medicine and Pharmacy