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

NCT ID: NCT06346171

Last Updated: 2025-03-19

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-01
• Study Completion Date: 2025-11-30

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.

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.

Conditions

Procedural Anxiety; Procedural Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Virtual Reality Integrative Psychotherapy

Intervention Type: 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).

Virtual Reality Distraction

Intervention Type: 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.

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.

Group Type: SHAM_COMPARATOR

Virtual Reality Distraction

Intervention Type: 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.

Control group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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).

Intervention Type: BEHAVIORAL

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.

Intervention Type: DEVICE

Other Intervention Names

VRIP; VRD

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Grigore T. Popa University of Medicine and Pharmacy

OTHER

Sponsor Role: lead

Responsible Party

Marcel-Alexandru Gaina

MD assist prof Marcel-Alexandru Gaina

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marcel A Gaina, ass.prof. MD

Role: STUDY_DIRECTOR

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

Cristinel Stefanescu, Prof. MD

Role: STUDY_CHAIR

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

Locations

University of Medicine and Pharmacy Grigore T Popa

Iași, Iaşi, Romania

Countries

Romania

References

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.

Reference Type: BACKGROUND

PMID: 35329993 (View on PubMed)

Other Identifiers

408/06.03.2024

Identifier Type: -

Identifier Source: org_study_id