The Management of Pain and Anxiety, Using Virtual Reality, During the Care of Elderly Hospitalized Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 87
- 试验地点
- 1
- 主要终点
- Visual Analog Scale (VAS) - Pain and Anxiety
研究概览
简要总结
The medical environment can create stressful and anxiety-provoking situations for patients, especially during painful procedures, particularly in older adults. These stressful environments have a deleterious effect on the quality of care, even putting the patient at risk and the health care team at risk. The search for a solution is therefore imperative. The evolution of new technologies, such as virtual reality (VR), seems to be an answer to this challenge. Through a multidisciplinary research (psychology and medicine), this project proposes to study the factors allowing to improve the management of older adults during their care using VR. More precisely, different individual factors (age, cognitive level, individual preferences...) and different virtual reality universes (relaxation, landscapes...) on different supports (headsets and touch tablet) will be studied in order to understand the roles of these factors on pain and anxiety management during care procedures. This trial is an interventional, randomized, open-label, single-center study of 100 people over 60 years old. The aim of this project is to improve the quality of life of hospitalized patients but also of caregivers in their work environment. It is expected a significant reduction of pain and anxiety during the intervention with a personalized equipment and environment, compared to usual care conditions. The hypotheisis is also that these interventions, aimed at reducing pain and anxiety in patients, will have beneficial effects on the quality of work life of the caregivers performing the care.
详细描述
The management of pain and anxiety, during care, will be proposed to patients hospitalized in the geriatric department of the Cimiez Hospital in Nice. After signing the consent form, the equipment and the different virtual environments will be presented to the patient and he will choose his preferred environment.Each patient will be accompanied during a treatment (either in control condition, or in VR condition with a VR condition with a personalised environment (VREP), or in VR condition with a environment (VRNP) for an average of 15 minutes (including the completion of the (including the completion of scales and questionnaires). Assessments will be carried out just before the treatment and just after the treatment.
After the treatment, the caregiver will also be asked to complete a scale assessing After the treatment, the carer will also be asked to complete a scale assessing the treatment (2 minutes on average to complete this scale).
And at the end of the study, the caregivers who participated in the study will be asked to rate their acceptability of VR using the User Experience Survey.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or Women
- •Over 60 years old
- •Subject affiliated to the Social Security
- •Patient receiving 4 identical cares as part of routine care
排除标准
- •Presence of visual and auditory disorders contraindicating the use of a VR headset;
- •Unstabilized epilepsy;
- •Acute psychiatric disorders
- •Vulnerable population
研究组 & 干预措施
control condition
The patient will be randomized so that the kind of intervention will be determined in a random way.
干预措施: Accompaing cares (Other)
with VR
The patient will be randomized so that the kind of intervention will be determined in a random way.
干预措施: Accompaing cares (Other)
with VR personalised
The patient will be randomized so that the kind of intervention will be determined in a random way.
干预措施: Accompaing cares (Other)
结局指标
主要结局
Visual Analog Scale (VAS) - Pain and Anxiety
时间窗: immediatly after care
The Visual Analog Scale (VAS) is a self-report scale that allows the patient to evaluate their feelings using a slider that goes from 0 to 10 points (worse score is 10)
Visual Analog Scale (VAS) - Pain and Anxiety
时间窗: immediatly before care
The Visual Analog Scale (VAS) is a self-report scale that allows the patient to evaluate their feelings using a slider that goes from 0 to 10 points (worse score is 10)
次要结局
- Algo Plus Scale(during care)
- HAD scale (Hospital Anxiety Depression scale)(immediately after care)
- Respiratory rate with Oximeter(2 minutes after the medicale procedure)
- Heart rate measurment with Oximeter(2 minutes after the medicale procedure)
- Digital scale of care completion(after each care)
- System Usability Scale (SUS)(at the end of the study)
- HAD scale (Hospital Anxiety Depression scale)(immediately beafore care)
- Heart rate measurment with Oximeter(2 minutes before the medicale procedure)
- Respiratory rate with Oximeter(2 minutes before the medicale procedure)