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O estudo clínico NCT06346171 (VRIPanx-COL) para Ansiedade procedimental, Dor procedimental está ativo, não recrutando. Consulte a visualização em cartões do Radar de Estudos Clínicos e as ferramentas de descoberta de IA para ver todos os detalhes. Ou pergunte qualquer coisa aqui. | ||
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VR Augmented Human Delivered Integrative Psychotherapy for Colonoscopy Procedural Anxiety and Pain (VRIPanx-COL) 36 Virtual
Os detalhes do estudo clínico estão disponíveis principalmente em inglês. No entanto, a IA Trial Radar pode ajudar! Basta clicar em 'Explicar o estudo' para visualizar e discutir as informações do estudo no idioma selecionado.
O estudo clínico NCT06346171 (VRIPanx-COL) é um estudo intervencionista para Ansiedade procedimental, Dor procedimental. Seu status atual é: ativo, não recrutando. O estudo começou em 1 de junho de 2024 e pretende incluir 36 participantes. Coordenado por Grigore T. Popa University of Medicine and Pharmacy e deve ser concluído em 30 de novembro de 2025. Essas informações foram atualizadas no ClinicalTrials.gov em 19 de março de 2025.
Resumo
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 impact...Mostrar mais
Descrição detalhada
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...
Mostrar maisTítulo oficial
Evaluating a Virtual Reality Augmented Clinician-Delivered Integrative Psychotherapy Model for Non-Sedated Colonoscopy Procedural Anxiety and Pain: A Prevalidation Trial Protocol (VRIPanx-COL)
Condições médicas
Ansiedade procedimentalDor procedimentalPublicações
Artigos científicos e trabalhos de pesquisa publicados sobre este estudo clínico:Outros IDs do estudo
- VRIPanx-COL
- 408/06.03.2024
Número NCT
Data de início (real)
2024-06-01
Última atualização postada
2025-03-19
Data de conclusão (estimada)
2025-11-30
Inscrição (estimada)
36
Tipo de estudo
Intervencionista
FASE
N/A
Status
Ativo, não recrutando
Palavras-chave
colonoscopy
anxiety
pain
virtual reality
psychotherapy
anxiety
pain
virtual reality
psychotherapy
Propósito principal
Tratamento
Alocação do design
Randomizado
Modelo de intervenção
Paralelo
Cegamento (Mascaramento)
Triplo-cego
Braços / Intervenções
| Grupo de participantes/Braço | Intervenção/Tratamento |
|---|---|
ExperimentalVirtual 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. | 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). V...Mostrar mais 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 U...Mostrar mais |
Comparador simuladoVirtual 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. | 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 U...Mostrar mais |
Nenhuma intervençãoControl group This group will undergo treatment as usual according to state-of-the-art guidelines for non-sedated colonoscopy. | N/A |
Desfecho primário
Desfecho secundário
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
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). |
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
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. |
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. |
Assistente de participação
Critérios de elegibilidade
Idades elegíveis
Adulto, Idoso
Idade mínima
18 Years
Sexos elegíveis
Todos
Aceita voluntários saudáveis
Sim
- scheduled non-sedated colonoscopy.
- cognitive ability to understand study aims;
- willingness to participate and provide written consent.
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.
Grigore T. Popa University of Medicine and PharmacyResponsável pelo estudo
Marcel-Alexandru Gaina, Investigador principal, MD assist prof Marcel-Alexandru Gaina, Grigore T. Popa University of Medicine and Pharmacy
Sem dados de contato.
1 Locais do estudo em 1 países
Iaşi
University of Medicine and Pharmacy Grigore T Popa, Iași, Iaşi, 700115, Romania