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O estudo clínico NCT07493499 (VR-RECOVER) para Cirurgia abdominal, Recuperação pós-operatória, Dor pós-operatória, Duração da estadia hospitalar está em recrutamento. 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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Virtual Reality for Postoperative Recovery After Major Abdominal Surgery (VR-RECOVER) 60 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 NCT07493499 (VR-RECOVER) é um estudo intervencionista para Cirurgia abdominal, Recuperação pós-operatória, Dor pós-operatória, Duração da estadia hospitalar. Seu status atual é: em recrutamento. O estudo começou em 1 de fevereiro de 2026 e pretende incluir 60 participantes. Coordenado por a Universidade de Alexandria e deve ser concluído em 1 de abril de 2026. Essas informações foram atualizadas no ClinicalTrials.gov em 25 de março de 2026.
Resumo
Major abdominal surgery often leads to significant postoperative pain, anxiety, and prolonged hospital stays, which can delay overall recovery. This study aims to evaluate the effectiveness of immersive Virtual Reality (VR) as a non-pharmacological intervention to enhance the quality of recovery and reduce the length of hospital stay. Patients in the intervention group will engage in standardized VR sessions featurin...Mostrar mais
Título oficial
Effect of Virtual Reality on Quality of Recovery and Hospital Stay After Major Abdominal Surgery
Condições médicas
Cirurgia abdominalRecuperação pós-operatóriaDor pós-operatóriaDuração da estadia hospitalarOutros IDs do estudo
- VR-RECOVER
- AU-20-10-457
Número NCT
Data de início (real)
2026-02
Última atualização postada
2026-03-25
Data de conclusão (estimada)
2026-04
Inscrição (estimada)
60
Tipo de estudo
Intervencionista
FASE
N/A
Status
Em recrutamento
Palavras-chave
Virtual Reality
VR Therapy
Distraction Therapy
ERAS (Enhanced Recovery After Surgery)
Perioperative Care
Non-pharmacological Pain Management
VR Therapy
Distraction Therapy
ERAS (Enhanced Recovery After Surgery)
Perioperative Care
Non-pharmacological Pain Management
Propósito principal
Cuidados de suporte
Alocação do design
Randomizado
Modelo de intervenção
Paralelo
Cegamento (Mascaramento)
Cego simples
Braços / Intervenções
| Grupo de participantes/Braço | Intervenção/Tratamento |
|---|---|
ExperimentalVR Intervention Group Patients in this group will receive standard perioperative care based on the Enhanced Recovery After Surgery (ERAS) protocol, supplemented by immersive Virtual Reality (VR) sessions using a head-mounted display (Meta Quest). Sessions focus on pain distraction and guided relaxation. | Immersive Virtual Reality (VR) Immersive VR sessions using a head-mounted display (e.g., Meta Quest). The intervention includes:
Pre-operative session: 15 minutes the evening before surgery. Post-operative sessions: Twice daily from postoperative day 1 to postoperative day 3 (15-20 minutes each).
Content includes nature immersion, guided breathing, and mindfulness-based stress reduction to alleviate pain and anxiety. |
Comparador ativoControl Group Patients in this group will receive only the standard perioperative care according to the established ERAS protocol, including routine analgesia, early mobilization, and early oral feeding, without any VR exposure. | Standard Perioperative Care and Enhanced Recovery Protocol Patients in the control group will receive the standard hospital perioperative care according to the Enhanced Recovery After Surgery protocol. This comprehensive care plan includes:
Pre-operative Phase: Detailed patient counseling and administration of carbohydrate-rich drinks before surgery to reduce metabolic stress.
Intra-operative Phase: Use of short-acting anesthetic agents, opioid-sparing analgesia, and optim...Mostrar mais |
Desfecho primário
Desfecho secundário
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
Quality of Postoperative Recovery | A validated 15-item self-reported questionnaire assessing five domains: emotional state, physical comfort, psychological support, physical independence, and pain. Total scores range from 0 (poorest recovery) to 150 (excellent recovery). | From Postoperative Day 1 to Postoperative Day 3. |
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
Length of Stay | The total number of days from the date of surgery until the patient meets the clinical discharge criteria (PADSS score ≥ 9). | From date of surgery until hospital discharge (up to 30 days). |
Postoperative Quality of Life | A 26-item tool used to assess quality of life across four domains: Physical, Psychological, Social, and Environmental. Scores are transformed into a 0-100 scale, where higher scores indicate better quality of life. | Upon hospital discharge, anticipated to occur between 3 to 7 days post-surgery. |
Post-Anesthetic Discharge Scoring System (PADSS) | A clinical scoring system assessing five criteria: vital signs, ambulation, nausea/vomiting, pain, and surgical bleeding. A score of ≥ 9 indicates readiness for discharge. | Daily from Postoperative Day 1 until discharge. |
Assistente de participação
Critérios de elegibilidade
Idades elegíveis
Adulto
Idade mínima
18 Years
Sexos elegíveis
Todos
- Adult patients aged 18 to 60 years.
- Scheduled for elective major abdominal surgery (e.g., colorectal, gastric, or hepatobiliary procedures).
- Physical and cognitive ability to provide informed consent.
- Ability to use and interact with Virtual Reality (VR) equipment (head-mounted display).
- Followed the standardized Enhanced Recovery After Surgery (ERAS) protocol at the hospital.
- Patients with a history of epilepsy or photosensitive seizures.
- Significant cognitive impairment or diagnosed psychiatric disorders that may interfere with study participation.
- Severe visual or auditory impairments that prevent effective interaction with VR content.
- Patients with pre-existing motion sickness or severe vertigo.
- Presence of open wounds or infections in the head/face area that prevent wearing the VR headset.
Responsável pelo estudo
Mohamed Fakhry Ahmed Salem, Investigador principal, Lecturer of Medical-Surgical Nursing, Alexandria University
Contato central do estudo
Contato: Mohamed Fakhry Ahmed Salem Dr. Mohamed Fakhry Ahmed Salem, PhD, +201286038014, [email protected]
1 Locais do estudo em 1 países
Faculty of Nursing, Alexandria University, Alexandria, 21511, Egypt
Mohamed Fakhry, PhD Medical-Surgical Nursing, Contato, 01286038014, [email protected]
Contato, [email protected]
Mohamed Fakhry, PhD Medical-Surgical Nursin, Investigador principal
Em recrutamento