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

March 1, 2023 updated by: Hospital Israelita Albert Einstein
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

212

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Brazil
      • São Paulo, Brazil, 05652000
        • Hospital Israelita Albert Einstein

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Group
The control group will not have access to VR.
Active Comparator: Intervention Group
Participants in the intervention group will use VR for 20 minutes for 2 consecutive days.
Behavioral: Intervention
Participants will watch nature images in virtual reality from the e-Natureza VR Database for 20 minutes for 2 consecutive days.
Other Names:
  • e-Nature VR

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline Oxygen Saturation Percentage at post intervention.
Time Frame: Immediately post-intervention for 2 consecutive days.
Quantify the change from baseline of pulse oximetry on the monitor in the intensive care unit, immediately after the intervention on the first day of Virtual Reality use (D1) and immediately after on the second day (D2).
Immediately post-intervention for 2 consecutive days.
Change from Baseline Blood Pressure Values at post intervention.
Time Frame: Immediately post-intervention for 2 consecutive days.
Quantify the change from baseline of blood pressure values on the monitor in the intensive care unit, immediately after the intervention on the first day of Virtual Reality use (D1) and immediately after on the second day (D2).
Immediately post-intervention for 2 consecutive days.
Change from Baseline Respiratory Rate Values at pos intervention.
Time Frame: Immediately post-intervention for 2 consecutive days.
Quantify the change from baseline of respiratory rate values on the monitor in the intensive care unit, immediately after the intervention on the first day of Virtual Reality use (D1) and immediately after on the second day (D2).
Immediately post-intervention for 2 consecutive days.
Change from Baseline Heart Rate Values at pos intervention.
Time Frame: Immediately post-intervention for 2 consecutive days.
Quantify the change from baseline of heart values on the monitor in the intensive care unit, immediately after the intervention on the first day of Virtual Reality use (D1) and immediately after on the second day (D2).
Immediately post-intervention for 2 consecutive days.
Change from Baseline Pain Perception at pos intervention.
Time Frame: Immediately post-intervention for 2 consecutive days.
Will be applied the Visual Analogue Scale - VAS. It is one of the most used instruments for pain assessment with a score from 0 to 10 that allows the patient to evaluate the pain of the procedure through a visual analogue scale numbered from zero to ten, with zero no pain, ten being the worst pain ever felt in life.The scale will be applied immediately after the first day (D1) of intervention using Virtual Reality and immediately after the second day (D2).
Immediately post-intervention for 2 consecutive days.
Change from Baseline Affective States pos intervention.
Time Frame: Immediately post-intervention for 2 consecutive days.
Will be applied the Positive and Negative Affect Schedule - PANAS. It is one of the most used instruments in the investigation of affective states composed of 20 questions and each item can be rated on a likert type frequency scale of sensations, raging from 0 (not at all) to 5 (extremely). The questionnaire will be applied immediately after the first day (D1) of intervention using Virtual Reality and immediately after the second day (D2).
Immediately post-intervention for 2 consecutive days.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in length of stay in the intensive care unit pos intervention
Time Frame: Immediately post-intervention for 2 consecutive days.
The days of hospitalization in intensive care of patients in the intervention group will be evaluated and will be compared with the days of stay in the control group.
Immediately post-intervention for 2 consecutive days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Israelita Albert Einstein

Collaborators

Beneficência Portuguesa de São Paulo

Investigators

  • Principal Investigator: Eliseth R Leão, PhD, Hospital Israelita Albert Einstein
  • Study Chair: Roberta M Savieto, MNP, Hospital Israelita Albert Einstein
  • Study Chair: Gabriela AG Gouveia, BPT, Beneficencia Portuguesa de Sao Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2024

Primary Completion (Anticipated)

May 1, 2024

Study Completion (Anticipated)

December 1, 2024

Study Registration Dates

First Submitted

November 8, 2022

First Submitted That Met QC Criteria

November 8, 2022

First Posted (Actual)

November 15, 2022

Study Record Updates

Last Update Posted (Actual)

March 3, 2023

Last Update Submitted That Met QC Criteria

March 1, 2023

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • e-Nature VR - ICU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pain

Clinical Trials on Intervention

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Slovenia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe