Clinical trial NCT06346171: VR Augmented Human Delivered Integrative Psychotherapy for Colonoscopy Procedural Anxiety and Pain
Official title: Evaluating a Virtual Reality Augmented Clinician-Delivered Integrative Psychotherapy Model for Non-Sedated Colonoscopy Procedural Anxiety and Pain: A Prevalidation Trial Protocol (VRIPanx-COL)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Procedural Anxiety
Procedural Pain
Keywords: colonoscopy
anxiety
pain
virtual reality
psychotherapy
Lead sponsor: Grigore T. Popa University of Medicine and Pharmacy
Sponsor class: OTHER
First posted: 2024-04-03
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Reduction in Procedure-Related Anxiety
timeFrame: STAY-Y1: baseline anxiety measured within 20 minutes before the procedure; post-procedural anxiety (within 20 minutes after the procedure's completion).
measure: Pain perception
timeFrame: Within 20 minutes before the colonoscopy procedure (baseline) and immediately after the procedure (within 20 minutes post-procedure).
Secondary outcomes:
measure: Feasibility and Acceptability of VRIP-Col Interventions
timeFrame: Data on feasibility and acceptability will be collected within 24 hours after the colonoscopy procedure.
measure: Qualitative Feedback on VRIP-Col Interventions
timeFrame: Data on feasibility and acceptability will be collected within 24 hours after the colonoscopy procedure.
Other outcomes:
measure: Trait anxiety
timeFrame: Within 72 hours after study enrolment.
measure: Quality of Life impact VRIP-Col
timeFrame: Within 36 hours before and after the colonoscopy procedure.
Locations:
city: Iaşi
country: Romania
facility: University of Medicine and Pharmacy Grigore T Popa
state: Iasi
Study officials:
affiliation: University of Medicine and Pharmacy "Grigore T Popa" Iasi, Romania
name: Marcel A Gaina, ass.prof. MD
role: STUDY_DIRECTOR
affiliation: University of Medicine and Pharmacy "Grigore T Popa" Iasi, Romania
name: Cristinel Stefanescu, Prof. MD
role: STUDY_CHAIR
References:
citation: 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.