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NCT06346171
NA

VR Augmented Human Delivered Integrative Psychotherapy for Colonoscopy Procedural Anxiety and Pain

Sponsor: Grigore T. Popa University of Medicine and Pharmacy

View on ClinicalTrials.gov

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.

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)

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

36

Start Date

2024-06-01

Completion Date

2025-11-30

Last Updated

2025-03-19

Healthy Volunteers

Yes

Interventions

BEHAVIORAL

Virtual Reality Integrative Psychotherapy

Music therapy: "Weightless" by Marconi Union plays continuously, bridging VR distraction and psychotherapy. Before: Patients pick a VR scene (-13 to -10 min), learn VR navigation, and practice 4-7-8 breathing with a VR flower for grounding and resilience (-10 to -9 min). They continue 4-7-8 doing Progressive Muscle Relaxation (4+7 contraction, 8 relaxation), moving from lower body to facial muscles (-8 to -5 min). Values and commitment to action are discussed (-4 to -2 min), emphasizing present-focused thoughts and acceptance (-1 min). During: Mindfulness and relaxation are encouraged, with PMR during intense moments. Empowerment and procedural feedback are provided (0 to 30/45 min). After: Debriefing normalizes the experience, reinforcing proactive health actions (35 to 50 min).

DEVICE

Virtual Reality Distraction

Software: Nature Treks VR nature environments. Hardware: dedicated head-mounted VR display (Oculus Rift S.) powered by a high-end computer (Laptop with at least GTX 1080 graphics card, both with processing units that lower the bottleneck chances); minimum specifications should facilitate presence while limiting cybersickness by ensuring refresh rates beyound 85 frames/second. Music therapy: "Weightless" by Marconi Union plays continuously, facilitating sensorial distraction while also allowing blinding. Although the psychotherapist will interact with the patient, the dialogue will exclude psychotherapic approaches. The dialogue is designed to be neutral, resembling a comprehensive tutorial for the VR experience. This serves as a comparator to assess the added value of integrating psychotherapeutic techniques within the VR experience.

Locations (1)

University of Medicine and Pharmacy Grigore T Popa

Iași, Iaşi, Romania