Clinical trial NCT05617638: Impact of Virtual Reality (e-Nature VR) During Hospitalization in Adult Intensive Care Unit
Official title: Impact of Virtual Reality (e-Nature VR) During Hospitalization in Adult Intensive Care Unit
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Pain
Keywords: virtual reality
intensive care unit
nature
wellness
Lead sponsor: Hospital Israelita Albert Einstein
Sponsor class: OTHER
Collaborators: name: Beneficência Portuguesa de São Paulo
First posted: 2022-11-15
Enrollment: 212
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Randomized clinical trial to analyze the perceived impact of the virtual reality intervention on the experience of pain and well-being, and the influence on vital signs and the relationship with the length of stay in the intensive care unit.

Detailed description: The highly specialized and complex technology used in intensive care units to provide continuous monitoring of the patient health context makes possible to increase the survival of patients with critical and unstable clinical status, but increases the triggering factors of the stress of hospitalized patients. Staying in these therapy units is accompanied by additional stress, confusional mental states, cognitive dysfunction, and depression. Virtual reality is a technique that involves the use of computer technology to create the effect of an interactive three-dimensional world in which objects have a spatial presence reducing the suffering related to a medical procedure, without side effects and without the need for additional personnel. Actual exposure to nature can be difficult to achieve for patients admitted to intensive care. Therefore, exposure to nature via media devices, and virtual reality (VR) is considered a promising technology due to its advantage in creating a sense of immersion. Furthermore, some evidence indicates that virtual nature can improve attentional resources, cognitive performance, and pain experience.

This clinical trial aims to analyze the influence of VR use in patients of Intensive Care Unit (ICU). After informed the consent form, participants will be randomly into control and intervention groups. Blood pressure, heart rate, respiratory rate, oxygen saturation will be evaluated, in addition to the experience of well-being and pain immediately before and immediately after the intervention for 2 consecutive days.The hypothesis of the study is that VR will positively influence vital signs and lived experiences, which will consequently reduce the length of stay in the ICU.

Eligibility criteria: Inclusion Criteria:

* individuals of both sexes;
* without communication, vision, hearing or intellectual disabilities;
* capable of mental to fill in the questionnaires;
* who watch at least 5 minutes of the video, minimum physiological immersion time.

Exclusion Criteria:

* use of sedatives;
* those who experience considerable discomfort possibly caused by virtual reality such as nausea, dizziness or headache, with a history of vertigo, nausea, vomiting;
* convulsion, labyrinthitis, epilepsy, dementia, mental confusion, psychomotor agitation;
* claustrophobia or expressing a desire to discontinue the study;
* patients who use anticholinergic drugs (antipsychotics and benzodiazepines);
* delirium;
* clinical worsening.

Primary outcomes:
measure: Change from Baseline Oxygen Saturation Percentage at post intervention.
timeFrame: Immediately post-intervention for 2 consecutive days.
measure: Change from Baseline Blood Pressure Values at post intervention.
timeFrame: Immediately post-intervention for 2 consecutive days.
measure: Change from Baseline Respiratory Rate Values at pos intervention.
timeFrame: Immediately post-intervention for 2 consecutive days.
measure: Change from Baseline Heart Rate Values at pos intervention.
timeFrame: Immediately post-intervention for 2 consecutive days.
measure: Change from Baseline Pain Perception at pos intervention.
timeFrame: Immediately post-intervention for 2 consecutive days.
measure: Change from Baseline Affective States pos intervention.
timeFrame: Immediately post-intervention for 2 consecutive days.
Secondary outcomes:
measure: Change in length of stay in the intensive care unit pos intervention
timeFrame: Immediately post-intervention for 2 consecutive days.
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Hospital Israelita Albert Einstein
Study officials:
affiliation: Hospital Israelita Albert Einstein
name: Eliseth R Leão, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Israelita Albert Einstein
name: Roberta M Savieto, MNP
role: STUDY_CHAIR
affiliation: Beneficência Portuguesa de São Paulo
name: Gabriela AG Gouveia, BPT
role: STUDY_CHAIR
References:
citation: Rousseaux F, Dardenne N, Massion PB, Ledoux D, Bicego A, Donneau AF, Faymonville ME, Nyssen AS, Vanhaudenhuyse A. Virtual reality and hypnosis for anxiety and pain management in intensive care units: A prospective randomised trial among cardiac surgery patients. Eur J Anaesthesiol. 2022 Jan 1;39(1):58-66. doi: 10.1097/EJA.0000000000001633.