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

Evaluating a Virtual Reality Augmented Clinician-Delivered Integrative Psychotherapy Model for Non-Sedated Colonoscopy Procedural Anxiety and Pain: A Prevalidation Trial Protocol (VRIPanx-COL)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Procedural Pain; Procedural Anxiety
• Intervention / Treatment: Behavioral: Virtual Reality Integrative Psychotherapy; Device: Virtual Reality Distraction

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 Type: Interventional
• Enrollment (Estimated): 36
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marcel A Gaina, ass.prof. MD; Phone Number: 0040 756901749; Email: marcel-alexandru_t_gaina@d.umfiasi.ro
• Study Contact Backup: Name: Gheorghe G Balan, Attd.prof.MD; Phone Number: 0040 744518195; Email: gheorghe-g-balan@umfiasi.ro

Study Locations

• Romania
  • Iasi
    • Iaşi, Iasi, Romania, 700115
      • University of Medicine and Pharmacy Grigore T Popa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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).; Other Names: VRIP; 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.; Other Names: VRD
Sham Comparator: 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.	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.; Other Names: VRD
No Intervention: Control group; This group will undergo treatment as usual according to state-of-the-art guidelines for non-sedated colonoscopy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction in Procedure-Related Anxiety	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.	STAY-Y1: baseline anxiety measured within 20 minutes before the procedure; post-procedural anxiety (within 20 minutes after the procedure's completion).
Pain perception	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).	Within 20 minutes before the colonoscopy procedure (baseline) and immediately after the procedure (within 20 minutes post-procedure).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Qualitative Feedback on VRIP-Col Interventions	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.	Data on feasibility and acceptability will be collected within 24 hours after the colonoscopy procedure.
Feasibility and Acceptability of VRIP-Col Interventions	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.	Data on feasibility and acceptability will be collected within 24 hours after the colonoscopy procedure.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Trait anxiety	STAI-Y2 will reveal the participants general anxiety in order for a more relevant group matching. Participants general tendency to perceive and respond to situations as threatening or anxiety-inducing. It will be applied after enrolling.	Within 72 hours after study enrolment.
Quality of Life impact VRIP-Col	Assessment of the bio-psycho-social interplay of VRIP as reflected by the score dynamic of the Health, Self-Esteem, relationships and Goals and Values items assessed by a qualified researcher using a Romanian population-standardised Quality of Life Inventory.	Within 36 hours before and after the colonoscopy procedure.

Collaborators and Investigators

• Sponsor: Grigore T. Popa University of Medicine and Pharmacy
• Collaborators: Romanian Academy
• Investigators: Study Director: Marcel A Gaina, ass.prof. MD, University of Medicine and Pharmacy "Grigore T Popa" Iasi, Romania; Study Chair: Cristinel Stefanescu, Prof. MD, University of Medicine and Pharmacy "Grigore T Popa" Iasi, Romania

Publications and helpful links

General Publications

• Gaina MA, Szalontay AS, Stefanescu G, Balan GG, Ghiciuc CM, Bolos A, Gaina AM, Stefanescu C. State-of-the-Art Review on Immersive Virtual Reality Interventions for Colonoscopy-Induced Anxiety and Pain. J Clin Med. 2022 Mar 17;11(6):1670. doi: 10.3390/jcm11061670.

Study record dates

Study Major Dates

• Study Start (Estimated): April 28, 2024
• Primary Completion (Estimated): August 30, 2024
• Study Completion (Estimated): November 30, 2024

Study Registration Dates

• First Submitted: March 28, 2024
• First Submitted That Met QC Criteria: March 28, 2024
• First Posted (Actual): April 3, 2024

Study Record Updates

• Last Update Posted (Actual): April 5, 2024
• Last Update Submitted That Met QC Criteria: April 4, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: pain; anxiety; colonoscopy; psychotherapy; virtual reality
• Additional Relevant MeSH Terms: Mental Disorders; Pain; Neurologic Manifestations; Anxiety Disorders; Pain, Procedural
• Other Study ID Numbers: 408/06.03.2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: 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.
• IPD Sharing Access Criteria: 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No