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

NCT06346171 | Active Not Recruiting DMC

• 1 other identifier: 408/06.03.2024
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Procedural Anxiety; Procedural Pain

Keywords

colonoscopy; anxiety; pain; virtual reality; psychotherapy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• 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.

Other Outcomes (2)

• Trait anxiety

  Within 72 hours after study enrolment.

• Quality of Life impact VRIP-Col

  Within 36 hours before and after the colonoscopy procedure.

Study Arms (3)

Virtual Reality Integrative Psychotherapy

EXPERIMENTAL

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; Device: Virtual Reality Distraction

Virtual Reality Distraction

SHAM COMPARATOR

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

Control group

NO INTERVENTION

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

Interventions

Virtual Reality Integrative Psychotherapy BEHAVIORAL

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).

Also known as: VRIP

Virtual Reality Integrative Psychotherapy

Virtual Reality Distraction DEVICE

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.

Also known as: VRD

Virtual Reality Distraction; Virtual Reality Integrative Psychotherapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: 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.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• scheduled non-sedated colonoscopy.
• cognitive ability to understand study aims;
• willingness to participate and provide written consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Grigore T. Popa University of Medicine and Pharmacy: lead

Study Sites (1)

University of Medicine and Pharmacy Grigore T Popa

Iași, Iaşi, 700115, Romania

Location

Related Publications (1)

• 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.

  PMID: 35329993 BACKGROUND

MeSH Terms

Conditions

Pain, Procedural; Anxiety Disorders; Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Marcel A Gaina, ass.prof. MD

  University of Medicine and Pharmacy "Grigore T Popa" Iasi, Romania

  STUDY DIRECTOR

• Cristinel Stefanescu, Prof. MD

  University of Medicine and Pharmacy "Grigore T Popa" Iasi, Romania

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD assist prof Marcel-Alexandru Gaina

Model Details: The VRIPanx-COL study is an RCT investigating the efficacy of VR-facilitated integrative psychotherapy compared to VR distraction only and NSE-Col. Variance minimisation and propensity score matching are used to ensure that the groups are balanced and to supplement the internal validity of evaluating the efficacy of the intervention.

Study Record Dates

• First Submitted: March 28, 2024
• First Posted: April 3, 2024
• Study Start: June 1, 2024
• Primary Completion: July 30, 2025
• Study Completion: November 30, 2025
• Last Updated: March 19, 2025

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• 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.
• 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.

Locations

RO (1)