PainNCT05617638

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

A study testing Intervention in people with Pain, run by Hospital Israelita Albert Einstein at 1 site in Brazil.

Suspended

Paused. Enrolment is on hold for now and may resume.

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Pain
What is being tested?: Intervention
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 212 participants
Where: 1 siteBrazil
Study dates: 27 Jun 2023to 25 Jun 2025
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Brazil1 site

Hospital Israelita Albert Einstein
São Paulo, São Paulo, 05652000

Other trials in Brazil

About this study

Read the 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.

Conditions: Pain
Being tested: Intervention
Keywords: virtual reality, intensive care unit, nature, wellness
Medical subject headings: Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT05617638
Study group	Role	What they receive
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. Receives: Behavioral: Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Immediately post-intervention for 2 consecutive days.

Secondary outcomes (1)

Change in length of stay in the intensive care unit pos intervention
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.
Measured: Immediately post-intervention for 2 consecutive days.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Jun 202325 Jun 2025

First posted15 Nov 2022
Study start27 Jun 2023
Primary completion1 May 2024
Study completion25 Jun 2025 (estimated)

Why it stopped: The study was definitively suspended due to the difficulty in including participants to reach the appropriate sample size

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for PainStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 212 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05617638
Sponsor's protocol ID: e-Nature VR - ICU
Status last verified: Sep 2024
First submitted: 8 Nov 2022
Last updated: 26 Jun 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 34783683

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Impact of Virtual Reality (e-Nature VR) During Hospitalization in Adult Intensive Care Unit
ClinicalTrials.gov ID: NCT05617638
Acronym / sponsor ID: e-Nature VR - ICU
Conditions: Pain
Keywords: virtual reality, intensive care unit, nature, wellness
Study type: Interventional
Recruitment status: SuspendedReason stopped: The study was definitively suspended due to the difficulty in including participants to reach the appropriate sample size
Enrolment: 212 participants (estimated)
Lead sponsor: Hospital Israelita Albert EinsteinUniversity, hospital or other
Collaborators: Beneficência Portuguesa de São Paulo
Study start: 27 Jun 2023 (actual)
Primary completion: 1 May 2024 (actual)
Study completion: 25 Jun 2025 (estimated)
First posted: 15 Nov 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Control Group	No intervention	–The control group will not have access to VR.
Intervention Group	Active comparator	Behavioral: InterventionParticipants in the intervention group will use VR for 20 minutes for 2 consecutive days.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (7 listed)

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);

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
InterventionAlso: e-Nature VRParticipants will watch nature images in virtual reality from the e-Natureza VR Database for 20 minutes for 2 consecutive days.	Behavioural	Intervention Group

Primary outcome

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).
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).
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).
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).
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).
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).

1 secondary outcome

Change in length of stay in the intensive care unit pos intervention
Time frame: Immediately post-intervention for 2 consecutive days.

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2025.
Background: PubMed 34783683Rousseaux 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Eliseth R Leão, PhD principal investigator

Hospital Israelita Albert Einstein

Roberta M Savieto, MNP study chair

Hospital Israelita Albert Einstein

Gabriela AG Gouveia, BPT study chair

Beneficência Portuguesa de São Paulo

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Intervention in people with Pain, run by Hospital Israelita Albert Einstein at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: paused, as of the sponsor's last update on 26 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline Oxygen Saturation Percentage at post intervention. (time frame: Immediately post-intervention for 2 consecutive days.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05617638, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2025.