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

NCT05617638 | Suspended DMC

• 1 other identifier: e-Nature VR - ICU
• Study Type: interventional
• Target: 212
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Keywords

virtual reality; intensive care unit; nature; wellness

Outcome Measures

Primary Outcomes (6)

• Change from Baseline Oxygen Saturation Percentage at post intervention.

  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.

  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.

  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.

  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.

  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.

  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 Outcomes (1)

• Change in length of stay in the intensive care unit pos intervention

  Immediately post-intervention for 2 consecutive days.

Study Arms (2)

Control Group

NO INTERVENTION

The control group will not have access to VR.

Intervention Group

ACTIVE COMPARATOR

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

Behavioral: Intervention

Interventions

Intervention BEHAVIORAL

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

Also known as: e-Nature VR

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Israelita Albert Einstein: lead
• Beneficência Portuguesa de São Paulo: collaborator

Study Sites (1)

Hospital Israelita Albert Einstein

São Paulo, São Paulo, 05652000, Brazil

Location

Related Publications (1)

• 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.

  PMID: 34783683 BACKGROUND

MeSH Terms

Conditions

Pain

Interventions

Methods

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Eliseth R Leão, PhD

  Hospital Israelita Albert Einstein

  PRINCIPAL INVESTIGATOR

• Roberta M Savieto, MNP

  Hospital Israelita Albert Einstein

  STUDY CHAIR

• Gabriela AG Gouveia, BPT

  Beneficência Portuguesa de São Paulo

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2022
• First Posted: November 15, 2022
• Study Start: June 27, 2023
• Primary Completion: May 1, 2024
• Study Completion: June 25, 2025
• Last Updated: June 26, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)