VR Augmented Human Delivered Integrative Psychotherapy for Colonoscopy Procedural Anxiety and Pain (VRIPanx-COL)

Grigore T. Popa University of Medicine and Pharmacy

Status: Active, not recruiting

Conditions: Procedural Anxiety; Procedural Pain

Treatments: Device: Virtual Reality Distraction; Behavioral: Virtual Reality Integrative Psychotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06346171

408/06.03.2024

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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36 participants in 3 patient groups

Virtual Reality Integrative Psychotherapy

Experimental group

Description:

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.

Treatment:

Behavioral: Virtual Reality Integrative Psychotherapy

Device: Virtual Reality Distraction

Virtual Reality Distraction

Sham Comparator group

Description:

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.

Treatment:

Device: Virtual Reality Distraction

Control group

No Intervention group

Description:

This group will undergo treatment as usual according to state-of-the-art guidelines for non-sedated colonoscopy.