e-Natureza Blue Care: Nature-based Virtual Reality and Pain Perception

NCT ID: NCT07053228

Last Updated: 2025-07-08

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

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-15

Study Completion Date

2026-03-30

Brief Summary

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This randomized clinical trial aims to evaluate the effectiveness of immersive nature-based virtual reality in managing chronic pain among oncology patients. The study seeks to expand non-pharmacological treatment options and contribute to the therapeutic arsenal available for chronic pain management in cancer care.The intervention utilizes immersive videos of diverse Brazilian natural environments to promote analgesic and emotional relief.

Detailed Description

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Pain is a global health issue and remains the most feared symptom among cancer patients. With over 14 million new cancer diagnoses annually and projections suggesting this number will triple by 2030. The majority of patients are diagnosed at an advanced stage, where pain is the predominant complaint. The concept of total pain, as described in palliative care, highlights the need for a multidimensional approach that addresses physical, psychological, social, and spiritual aspects.

In the management of chronic pain, complementary therapies such as acupuncture, meditation, and massage have gained prominence for offering holistic benefits without the side effects associated with pharmacological treatments. Another promising complementary approach involves exposure to natural environments. Immersive Virtual Reality (VR) is an innovative strategy that provides distraction and reduces pain perception by transporting patients to engaging, nature-based virtual settings.

This study is a randomized, controlled, parallel-group clinical trial designed to investigate the impact of an immersive virtual reality (VR) intervention with nature-themed content (blue spaces) on pain and emotional well-being in hospitalized cancer patients. The research will be conducted in three oncology units of a large private hospital in São Paulo, Brazil.

A total of 130 adult oncology inpatients experiencing chronic pain will be randomly assigned to either the intervention or control group. Participants in the control group will receive standard pain management as provided by the hospital's pain control team, guided by electronic medical records, and institutional pain protocols. The intervention group will receive the same standard care, plus a VR session using the Oculus Go headset and 360-degree nature videos with synchronized natural sounds (e.g., beach, waterfall, birdsong), lasting approximately 8 minutes.

Data will be collected using the following validated instruments:

Visual Analog Scale (VAS) for pain intensity,

PANAS for positive and negative affect,

Nature Connectedness Scale (NCS),

Sociodemographic and clinical questionnaire,

Analgesic Use Form, developed by researchers to quantify medication use and pharmacological class.

Ethical approval was obtained (CAAE: 86844425.5.0000.0071), and all participants will provide written informed consent. If the results are positive, the intervention will be made available to the hospital's pain management team for broader implementation in clinical practice.

Conditions

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Cancer Pain Palliative Care

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a randomized clinical trial, an experimental study involving human subjects aimed at evaluating the effect of a health-related intervention. After signing the informed consent form, participants will be randomly assigned via the Randomizer software to either the control or intervention group. Patients in the control group will receive standard pain management, which includes pharmacological treatment and monitoring through electronic medical records (EMRs). When pain is not adequately controlled, the institutional Pain Management Team conducts an in-depth EMR review to tailor care, ensuring effective and continuous pain relief. The intervention group will receive standard care plus immersive nature-based virtual reality therapy. Five tools will be used for data collection: a Sociodemographic and Clinical Questionnaire, the Visual Analogue Scale , the Positive and Negative Affect Schedule , the Nature Connectedness Scale (NCS), and the Analgesic Experience Questionnaire
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Intervention - Nature-based Virtual Reality

Participants will view an 8-minute 360° 3D immersive video featuring natural Brazilian blue environments (beach, waterfall) developed using the Oculus Go. Pre- and post-intervention assessments will include: Visual Analog Scale (VAS), The Positive and Negative Affect Schedule (PANAS), After 24h, the Analgesic Experience Form will be completed. A sociodemographic/clinical questionnaire and Connectedness to Nature Scale (CNS) will be applied only pre-intervention.

Group Type EXPERIMENTAL

Nature-based virtual reality

Intervention Type BEHAVIORAL

Participants in this group will receive standard pain management care plus one session of immersive virtual reality (VR) using Oculus Go headsets. The session consists of viewing a nature-themed 360º video (e.g., beach, waterfall, songbirds) for approximately 8 minutes, accompanied by synchronized natural sounds.

The VR experience is designed to promote distraction, relaxation, and emotional engagement with nature to support pain relief and emotional regulation. The equipment is sanitized between uses according to hospital infection control protocols.

Control

Participants in the control group will receive standard care. They will undergo standard pain management as per institutional pain protocols. The same outcomes assessment will occur at the same time intervals as in the intervention group.

Group Type ACTIVE_COMPARATOR

Standard Pain Management

Intervention Type DRUG

Participants in this group will receive the institution's standard pharmacological pain management, monitored and adjusted by the Pain Control Team using the hospital's electronic medical record system. This may include opioid and non-opioid analgesics according to clinical evaluation.

No complementary interventions will be provided during the study period.

Interventions

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Nature-based virtual reality

Participants in this group will receive standard pain management care plus one session of immersive virtual reality (VR) using Oculus Go headsets. The session consists of viewing a nature-themed 360º video (e.g., beach, waterfall, songbirds) for approximately 8 minutes, accompanied by synchronized natural sounds.

The VR experience is designed to promote distraction, relaxation, and emotional engagement with nature to support pain relief and emotional regulation. The equipment is sanitized between uses according to hospital infection control protocols.

Intervention Type BEHAVIORAL

Standard Pain Management

Participants in this group will receive the institution's standard pharmacological pain management, monitored and adjusted by the Pain Control Team using the hospital's electronic medical record system. This may include opioid and non-opioid analgesics according to clinical evaluation.

No complementary interventions will be provided during the study period.

Intervention Type DRUG

Other Intervention Names

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Non-pharmacological pain relief Pharmacological pain relief

Eligibility Criteria

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Inclusion Criteria

* hospitalized oncological patients with chronic pain.
* both sexes
* aged 18 years or older
* preserved clinical condition and communication abilities that allow participation in the study
* report pain documented in the electronic medical record

Exclusion Criteria

* Patients who are unable to tolerate wearing the virtual reality (VR) headset for at least 8 minutes
* blind patients
* patients who experience any side effects or worsening clinical condition during the interview/intervention period
* patients undergoing other complementary treatments
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Israelita Albert Einstein

OTHER

Sponsor Role lead

Responsible Party

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Eliseth Ribeiro Leao

Nurse Scientist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eliseth R Leão, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Israelita Albert Einstein

Locations

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Hospital Albert Einstein

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

Central Contacts

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Eliseth R Leão, PhD

Role: CONTACT

+5511996186489

Cibele T Souza, BSN

Role: CONTACT

+5511981974214

Facility Contacts

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Eliseth R Leão, PhD

Role: primary

Cibele T Souza, BSN

Role: backup

References

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Kelleher SA, Fisher HM, Winger JG, Miller SN, Amaden GH, Somers TJ, Colloca L, Uronis HE, Keefe FJ. Virtual reality for improving pain and pain-related symptoms in patients with advanced stage colorectal cancer: A pilot trial to test feasibility and acceptability. Palliat Support Care. 2022 Aug;20(4):471-481. doi: 10.1017/S1478951521002017.

Reference Type BACKGROUND
PMID: 35078545 (View on PubMed)

Britton E, Kindermann G, Domegan C, Carlin C. Blue care: a systematic review of blue space interventions for health and wellbeing. Health Promot Int. 2020 Feb 1;35(1):50-69. doi: 10.1093/heapro/day103.

Reference Type BACKGROUND
PMID: 30561661 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Informed Consent Form

View Document

Other Identifiers

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86844425.5.0000.0071

Identifier Type: -

Identifier Source: org_study_id

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