protocolSection identificationModule nctId: NCT06346171, orgStudyIdInfo id: 408/06.03.2024, briefTitle: VR Augmented Human Delivered Integrative Psychotherapy for Colonoscopy Procedural Anxiety and Pain, acronym: VRIPanx-COL, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-28, primaryCompletionDateStruct date: 2024-08-30, completionDateStruct date: 2024-11-30, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Grigore T. Popa University of Medicine and Pharmacy, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Procedural Anxiety, conditions: Procedural Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: 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., primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: 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., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 36, type: ESTIMATED, armsInterventionsModule interventions name: Virtual Reality Integrative Psychotherapy, interventions name: Virtual Reality Distraction, outcomesModule primaryOutcomes measure: Reduction in Procedure-Related Anxiety, primaryOutcomes measure: Pain perception, secondaryOutcomes measure: Feasibility and Acceptability of VRIP-Col Interventions, secondaryOutcomes measure: Qualitative Feedback on VRIP-Col Interventions, otherOutcomes measure: Trait anxiety, otherOutcomes measure: Quality of Life impact VRIP-Col, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Medicine and Pharmacy Grigore T Popa, city: Iaşi, state: Iasi, zip: 700115, country: Romania, geoPoint lat: 47.16667, lon: 27.6, hasResults: False