Effects of Virtual Reality Hypnosis on Anxiety, Pain and Comfort in Oncology Patients During a Port-catheter Placement Procedure

Официальное название

Interest of Virtual Reality Hypnosis to Decrease Anxiety, Pain, and Discomfort of Patients With Cancer Having to Undergo an Invasive Intervention

Обзор

The port-catheter (PAC) is a longterm venous access device, frequently used in oncology patients. The PAC is an invasive technique, consisting of a reservoir surgically implanted in the chest wall or upper arm, and arm and a catheter. Patients can experience pain in the incision area after implantation, as well as anxiety before, during and after implantation. Virtual reality hypnosis (VRH) is an innovative technique delivering clinical hypnosis to patients through virtual reality (VR). The clinical applications of VRH are still little known. We will assess the anxiety, comofrt, pain perception and pain unpleasantness of 102 cancer patients scheduled to receive a PAC. The patients will be randomly divided into two groups. Thefirst group will benefit from the usual care for the placement of the PAC (i.e., local anaesthesia), while the second will benefit from the VRH in addition to the usual care. Pain perception, pain unpleasantness, anxiety, satisfaction, absorption, dissociation will be evaluated before and after the intervention.

Вмешательства

• Устройство Virtual reality hypnosis
  Virtual reality hypnosis

Первичные конечные точки

• Anxiety state [Срок оценки: Before PAC intervention, immediately after PAC intervention]
• Pain intensity [Срок оценки: Before PAC intervention, immediately after PAC intervention]
• Pain unpleasantness [Срок оценки: Before PAC intervention, immediately after PAC intervention]
• Comfort [Срок оценки: Before PAC intervention, immediately after PAC intervention]

Вторичные конечные точки (12)

• Anxiety trait [Срок оценки: From the day of the group assignment until beginning the PAC intervention, assessed up to two weeks]
• Dissociation trait [Срок оценки: From the day of the group assignment until beginning the PAC intervention, assessed up to two weeks]
• Dissociation state [Срок оценки: From the day of the group assignment until completion of the PAC intervention, assessed up to two weeks]
• Absorption trait [Срок оценки: From the day of the group assignment until beginning the PAC intervention, assessed up to two weeks]
• Absorption state [Срок оценки: From the day of the group assignment until completion of the PAC intervention, assessed up to two weeks]
• Time perception [Срок оценки: From the day of the group assignment until completion of the PAC intervention, assessed up to two weeks]
• Immersion tendencies [Срок оценки: From the day of the group assignment until beginning the PAC intervention, assessed up to two weeks]
• Satisfaction of the participant [Срок оценки: From the day of the group assignment until completion of the PAC intervention, assessed up to two weeks]
• Satisfaction of the surgeon [Срок оценки: From the day of the group assignment until completion of the PAC intervention, assessed up to two weeks]
• Medication [Срок оценки: During PAC intervention, 24 hours after PAC intervention, 48 hours after PAC, 7 days after PAC]
• Surgery duration [Срок оценки: From the day of the group assignment until completion of the PAC intervention, assessed up to two weeks]
• Fatigue [Срок оценки: 24 hours after PAC intervention, 48 hours after PAC, 7 days after PAC]

Критерии участия

Критерии включения

• Low auditory and/or visual acuity precludes the use of the device.
• Head or face wounds precluding the use of the device.
• Schizophrenia, dissociative disorder or any other psychiatric disorder.
• Non-proficiency in French (Research language).
• Patient under 18 years old.
• Phobia of deep water.
• Dizziness.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Бельгия · 2 центра

• CHR de Huy — Huy
• CHU of Liège — Liège

Идентификаторы

NCT: NCT06883786 · VRH-PAC

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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