Impact of Virtual Reality (e-Nature VR) During Hospitalization in Adult Intensive Care Unit

NCT ID: NCT05617638

Last Updated: 2025-06-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

NA

Total Enrollment

212 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-27

Study Completion Date

2025-06-25

Brief Summary

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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

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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.

Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Control Group

The control group will not have access to VR.

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention Group

Participants in the intervention group will use VR for 20 minutes for 2 consecutive days.

Group Type ACTIVE_COMPARATOR

Intervention

Intervention Type BEHAVIORAL

Participants will watch nature images in virtual reality from the e-Natureza VR Database for 20 minutes for 2 consecutive days.

Interventions

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Intervention

Participants will watch nature images in virtual reality from the e-Natureza VR Database for 20 minutes for 2 consecutive days.

Intervention Type BEHAVIORAL

Other Intervention Names

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e-Nature VR

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beneficência Portuguesa de São Paulo

OTHER

Sponsor Role collaborator

Hospital Israelita Albert Einstein

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eliseth R Leão, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Israelita Albert Einstein

Roberta M Savieto, MNP

Role: STUDY_CHAIR

Hospital Israelita Albert Einstein

Gabriela AG Gouveia, BPT

Role: STUDY_CHAIR

Beneficência Portuguesa de São Paulo

Locations

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Hospital Israelita Albert Einstein

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type BACKGROUND
PMID: 34783683 (View on PubMed)

Other Identifiers

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e-Nature VR - ICU

Identifier Type: -

Identifier Source: org_study_id

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