Evaluation of Virtual Reality to Reduce Anxiety, Pain and Duration of Non-emergency Vigile Bronchial Fibroscopy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Respiratory Disorder, Lung Infection

Intervention / Treatment
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* Device: Virtual reality headset


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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 Epilepsy 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients in whom elective BF has been scheduled and who have given consent to the study will be randomised (1:1) to either the control group (BF after local anaesthesia (LA)) or the experimental group (BF after AL and VR immersion). Randomization will be done 30 minutes before BF, after an initial assessment of anxiety (pre-BF VAS) and will be stratified according to whether or not a psychotropic drug and/or a level II analgesic is taken the day before or on the day of BF. The randomization list will be programmed in advance by the study statistician using SAS software and will be generated and edited by another statistician independent of the study from the HEGP clinical research unit. The randomization list will be kept by the study sponsor (AP-HP). It will be available to users via web-based software (CleanWeb software (Telemedicine Technologies, http: //www.tentelemed.com/la-solution-cleanweb/)].
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: interventional arm<br>Fibroscopy performed under local anesthesia with immersion in a virtual reality scenario | Device: Virtual reality headset<br>* A HEALTHY MIND® brand VR headset is dedicated to the study. The kit includes a noise-reducing audio headset, a face mask diffusing the visual part, a touchscreen tablet connected to the two VR headset systems, and a microphone connected to the tablet. The available software allows patients to choose between 5 natural environments in which a hypnotic speech is broadcast, available in several languages (French, English, Spanish, Russian, Arabic).<br>|
| No Intervention: Conventional arm<br>Fibroscopy performed under local anesthesia without immersion in a virtual reality scenario | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum value of patient's anxiety experienced during BF assessed by the visual analogue scale (VAS) immediately after the 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. | Immediately after BF | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The relative change of patient's anxiety before and after BF assessed by the STAI-A scale (state anxiety scale) | The Spielberger State-Trait Anxiety Inventory (STAI) is a 40-item self-report measure of anxiety using a 4-point Likert-type scale (from 1 to 4 points) for each item. It has two scales: State anxiety, i.e. how one feels at the moment; and Trait anxiety, i.e. how one generally feels. Both scales consist of 20 items. The state scale has 10 reverse-scored items, the trait scale has 7. Scores of both scales ranges from 20 to 80. | 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) | 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. | When leaving the intensive care unit or on the 7th day at the latest, post BF | 
| Patient's anxiety experienced during BF evaluated by the nursing staff assessed by the COVI behavior and somatic complaints scales immediately after the FB | The COVI scale consists of 3 items (subject's speech, behavior and somatic complaints) rated from 1 to 5 which assess speech, behavior and somatic complaints in anxious patients, with an overall score between 3 (no anxiety symptoms) and 15 (major anxiety). The behavior and somatic scales will be used. | Immediately after BF | 
| Maximum value of patient's pain experienced during BF assessed by the visual analogue scale (VAS) immediately after the FB | 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 pain and the other to maximum pain imaginable. The patient must then place the cursor where he locates his pain. VAS ranges from 0 to 100 mm. | Immediately after BF | 
| Patient's pain experienced during BF evaluated by the nursing staff assessed by the ALGOPLUS scale immediately after the FB | The ALGOPLUS scale was specifically developed to evaluate and manage acute pain in the elderly in all situations in which reliable self-assessment is not feasible. The scale is composed of 5 items (observational areas/domains). Each item checked yes is accorded 1 point and the sum of checked items gives a total score ranging from 1 to 5. | Immediately after BF | 
| The relative change of patient's maximum pulse measured during BF compared to pulse measured before 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 | 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 | The relative change of patient's maximum blood pressure measured during BF compared to blood pressure measured before BF | Immediately after BF | 
| The total dose of sedative and anxiolytic drugs prescribed during BF | The total dose of midazolam, alprazolam, hydroxyzine, diprivan, stage II or III analgesics prescribed during BF | Immediately after BF | 
| The quality of the BF assessed by a specific questionnaire completed by the physician in charge of the BF | A specific questionnaire completed by the physician in charge of the BF will be used describing the quality of the exploration and the possibility of taking samples | Immediately after BF | 
| The duration of BF (in minutes) from the start of the local anesthesia to the permanent removal of the fibroscopy | The duration of BF (in minutes) from the start of the local anesthesia to the permanent removal of the fibroscopy | Immediately after BF | 
| Remote patient's satisfaction on the BF procedure assessed 7 days post BF and measured by the e-SATIS questionnaire | E-SATIS is an experience and satisfaction questionnaire, in which all patients are invited to participate, following treatment in a health establishment, hospital or clinic. The questionnaire is validated by the French Haute autorité de santé. The patient care section of the questionnaire was used to assess remote patient's satisfaction on the BF procedure. For each responding patient, a score ranging from 1 [bad experience] to 5 [excellent experience] (transformed into a value from 0 to 100) is given to each of his answers. | 7 days post BF | 
| Tolerance to the VR assessed by a questionnaire measuring the side effects of the VR | The questionnaire items lists the side effects of the VR (8 items with 3 answer categories: yes, no and do not know). | 1 day post BF | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Virtual reality, Pulmonary fibroscopy, Anxiety, Pain, Intensive care