Evaluation de la réalité Virtuelle Pour réduire l'anxiété, la Douleur et de la durée d'Une Fibroscopie Bronchique Vigile Non Urgente en Soins Critiques
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 10
- 主要终点
- Maximum value of patient's anxiety experienced during BF assessed by the visual analogue scale (VAS) immediately after the BF
研究概览
简要总结
Bronchial fibroscopy (BF) is a routine practice examination in critical care areas. It can be useful either for the diagnosis of the causal pathology of respiratory distress or for the diagnosis of lung infection, sometimes nosocomial. In patients in spontaneous and conscious ventilation, BF are performed vigil after local anesthesia according to the recommendations of the Société de Pneumologie de langue Française. The good tolerance of the examination and its good conduct may require the use of anxiolytics, sedatives or analgesics to limit the traumatic experience of a highly anxiety-provoking examination. Virtual reality (VR) combines a set of paramedical techniques (hypnosis, music therapy, sophrology) and is now a non-drug alternative to improve the tolerance of certain invasive gestures.VR has been shown to reduce pain and anxiety during first pathways placement or digestive endoscopies. To date, there is no evidence of the benefit of VR when performing semi-urgent BF in critical care areas.
详细描述
Bronchial fibroscopy (BF) is an invasive examination mainly performed in vigilant patients under local anesthesia very regularly performed in patients hospitalized in critical care. Despite local anesthesia, and paradoxically also because of local anesthesia that makes the airflow in the upper airway imperceptible, BF is an anxiety-provoking and sometimes uncomfortable examination. Drug options are offered by physicians on a case-by-case basis and in response to patients' discomfort or anxiety. We believe that a preventive, non-drug strategy would improve comfort, reduce anxiety and improve patients' experience during BF. To reduce anxiety and improve patient comfort, there are non-drug alternatives such as hypnosis, music therapy or virtual reality. Hypnosis requires the availability of previously trained caregivers and a calm environment. Music therapy is difficult to apply in IS because of pre-existing noise pollution. We hypothesize that virtual reality would reduce patient anxiety during a bronchial fibroscopy in bed in critical care, improve the patient and caregiver experience and optimize its realization. Virtual reality (VR) is a technology that allows the patient to be projected, via a computer system, into an immersive virtual world. The patient's immersion in the virtual environment is accompanied by the feeling of "presence" which can be defined as the authentic feeling of existing in a world other than the one where the body is physically located.This specificity, coupled with the ability to isolate the patient's visual and auditory field, make this tool a promising solution to improve the well-being of patients during the care offer. VR is distributed by a set of devices to digitally simulate an environment mobilizing the different senses of its user: sight most often but possibly also touch, hearing or smell. VR, most often distributed via video and audio headset, is a complete immersive experience that can bring together hypnotic scenario and music therapy.
HEALTHY MIND® has designed a VR headset to relieve pain and anxiety in patients in healthcare facilities in a non-drug way. Indeed, this helmet has been developed to exercise analgesic and anxiolytic actions through specific virtual environments by combining different principles such as medical hypnosis, music therapy, light therapy and cardiac coherence. The proposed immersion themes combined with breathing exercises in the initial phase, generate better stress management.
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 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (over 18 years of age)
- •Hospitalized in a critical care unit (intensive care and intensive care)
- •Conscious (Glasgow score >13)
- •Spontaneous ventilation
- •Requiring the realization of a FB
- •First BF during hospitalization
- •Having signed a consent to participate in the study
- •Affiliation to social security
排除标准
- •Non-French-speaking patient
- •Protected minors or adults who cannot consent to participate
- •People with major neurocognitive impairment
- •Patient refusing to participate in the study
- •Patient on State medical aid
- •Patient under guardianship or curatorship or under judicial protection
- •BF for a vital emergency
- •Prior inclusion in the study
- •Pregnant or breastfeeding women
- •Presence of a tracheostomy or tracheostomy
- •Participation in other intervention research
- •Visual impairment (blindness) or severe hearing impairment (hearing loss, deafness) that does not allow the use of the helmet
- •Psychiatric pathologies such as delusional disorders, hallucinations or schizophrenia.
- •Autism spectrum disorders
- •Patient sensitive to motion sickness
- •Refractory migraine under treatment
结局指标
主要结局
Maximum value of patient's anxiety experienced during BF assessed by the visual analogue scale (VAS) immediately after the BF
时间窗: Immediately after BF
The visual analogue scale is a rating scale in the form of a 10 cm strip graduated in mm that can be presented horizontally or vertically. On the face presented to the patient, there is a cursor that he mobilizes on a straight line with one end corresponding to "absence of anxiety" and the other to "maximum anxiety imaginable". The patient must then place the cursor where he locates his anxiety. VAS ranges from 0 to 100 mm.
次要结局
- The relative change of patient's anxiety before and after BF assessed by the STAI-A scale (state anxiety scale)(Immediately after BF)
- Patient's anxiety when leaving the intensive care unit (or on the 7th day at the latest, after BF) assessed by the visual analogue scale (VAS)(When leaving the intensive care unit or on the 7th day at the latest, post BF)
- Maximum value of patient's pain experienced during BF assessed by the visual analogue scale (VAS) immediately after the FB(Immediately after BF)
- Patient's pain experienced during BF evaluated by the nursing staff assessed by the ALGOPLUS scale immediately after the FB(Immediately after BF)
- The relative change of patient's maximum pulse measured during BF compared to pulse measured before BF(Immediately after BF)
- The relative change of patient's maximum respiratory rate measured during BF compared to respiratory rate measured before BF(Immediately after BF)
- The relative change of patient's maximum blood pressure measured during BF compared to blood pressure measured before BF(Immediately after BF)
- The duration of BF (in minutes) from the start of the local anesthesia to the permanent removal of the fibroscopy(Immediately after BF)
- Tolerance to the VR assessed by a questionnaire measuring the side effects of the VR(1 day post BF)
- Patient anxiety experienced before BF evaluated by the nursing staff assessed by Hamilton scale(Before BF)
- The total dose of sedative and anxiolytic drugs administered during BF(Immediately after BF)
- The quality of FB (specific questionnaire completed by the physician describing the quality of exploration, the possibility of taking samples and the satisfaction VAS).(Immediately after BF)
- Remote patient satisfaction with FB measured using the e-SATIS ?questionnaire (Haute Autorité de Santé "prise en charge" section), and the answer to the single question: "Would you have a bronchial fibroscopy again in the future)(7 days post BF)
