Interest of Virtual Reality Hypnosis to Decrease Anxiety, Pain, and Discomfort of Patients with Cancer Having to Undergo an Invasive Intervention
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 102
- 试验地点
- 2
- 主要终点
- Anxiety state
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- 未提供
研究组 & 干预措施
Virtual reality hypnosis
The VRH session, called Aqua+© (120 Version 1.1, HypnoVR SAS, Strasbourg, France) It is an immersive and contemplative virtual experience combining music, sounds, and/or a vocal audio recording relating a hypnotic scenario and a 3D virtual video. The Aqua© VRH session follows the standard phases of hypnosis, beginning with induction, followed by suggestions, and ending with the exit of hypnosis.
干预措施: Virtual reality hypnosis (Device)
Control
Usual care. Local anesthesia only.
结局指标
主要结局
Anxiety state
时间窗: Before PAC intervention, immediately after PAC intervention
Anxiety state will be assessed using a numerical rating scale (NRS) ranging from 0 (no anxiety) to 10 (worst anxiety ever).
Pain intensity
时间窗: Before PAC intervention, immediately after PAC intervention
Pain intensity will be assessed using a numerical rating scale (NRS) ranging from 0 (no pain) to 10 (worst pain imaginable).
Pain unpleasantness
时间窗: Before PAC intervention, immediately after PAC intervention
Pain unpleasantness will be assessed using a numerical rating scale (NRS) ranging from 0 (no pain) to 10 (worst pain imaginable).
Comfort
时间窗: Before PAC intervention, immediately after PAC intervention
Comfort will be assessed using a numerical rating scale (NRS) ranging from 0 (no comfort) to 10 (maximum comfort).
次要结局
- Anxiety trait(From the day of the group assignment until beginning the PAC intervention, assessed up to two weeks)
- Dissociation trait(From the day of the group assignment until beginning the PAC intervention, assessed up to two weeks)
- Dissociation state(From the day of the group assignment until completion of the PAC intervention, assessed up to two weeks)
- Absorption trait(From the day of the group assignment until beginning the PAC intervention, assessed up to two weeks)
- Absorption state(From the day of the group assignment until completion of the PAC intervention, assessed up to two weeks)
- Time perception(From the day of the group assignment until completion of the PAC intervention, assessed up to two weeks)
- Immersion tendencies(From the day of the group assignment until beginning the PAC intervention, assessed up to two weeks)
- Satisfaction of the participant(From the day of the group assignment until completion of the PAC intervention, assessed up to two weeks)
- Satisfaction of the surgeon(From the day of the group assignment until completion of the PAC intervention, assessed up to two weeks)
- Medication(During PAC intervention, 24 hours after PAC intervention, 48 hours after PAC, 7 days after PAC)
- Surgery duration(From the day of the group assignment until completion of the PAC intervention, assessed up to two weeks)
- Fatigue(24 hours after PAC intervention, 48 hours after PAC, 7 days after PAC)
研究者
Audrey Vanhaudenhuyse
PhD, Responsible of the Sensation and Perception Research Group, in the GIGA CONSCIOUSNESS department
University of Liege