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.

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.

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.

Available to individuals of all self-identified genders, with endeavours to equilibrate representation across cohorts to acquire comparative insights concerning the reported vulnerability of the biological female sex to anxiety, pain, and discomfort.

Following the conclusion and dissemination of the primary results of our study, we are committed to sharing the IPD and its supplementary documentation - including the study protocol, statistical analysis plan, informed consent form, and the clinical study report - with qualified investigators bestowing a scientifically valid analysis proposal.

Beginning at a juncture of six months succeeding the disclosure of the principal results, the datasets will remain accessible for a span of three years. This provisional period is established to facilitate expedited access to data while preserving the sanctity of ongoing analyses and proprietary knowledge.

This framework is intended, in part, to allow immediate and early data access, while also preserving the privacy of concurrent analyses and integrity of intellectual property. mplementation of successful proposal submission for any qualified investigator with a scientifically valid and beneficial proposal for solving a significant provider or patient health issue based directly on the primary research questions or the study objectives. A specially constituted and independent review panel of external scientific experts and research experts will evaluate the submitted proposals. Data use agreement: A basic agreement declaring the responsible and ethical use of the data and requiring the investigators to certify privacy protocols and to safeguard patient-specific information.

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.