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Completed

NCT Number: NCT07785245

Immersive Meditation for Managing Preoperative Distress.

This pilot randomized controlled trial (N=60) investigates the efficacy of a brief, combined Virtual Reality (VR) and mindfulness meditation intervention and a VR nature intervention for breast cancer patients in the immediate pre-surgical waiting period.

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Key information

Conditions

Presurgical Distress Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Champalimaud Foundation - Breast Unit

Lisbon, Lisbon District, 1400-038, Portugal

About this study

Preoperative anxiety in breast cancer patients is highly prevalent and associated with adverse post-surgical outcomes. This study compares immersive virtual reality alone with the same nature based virtual environment combined with guided mindfulness meditation to determine if the therapeutic benefits of immersive technology can be enhanced by active psychological interventions. The trial evaluates patient-reported anxiety and fear, physiological measures, and incorporates an innovative computational semantic analysis of post-operative patient interviews.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Female patients aged 18 years or older

Capable of providing written informed consent

Scheduled for elective breast cancer surgery requiring general anaesthesia

Possessing sufficient vision and hearing to engage with the VR experience

Exclusion criteria

Severe visual or auditory impairments

Cognitive deficits that would preclude engagement with the VR hardware

A history of motion sickness or known contraindications to VR exposure

Treatment and study plan

Immersive Virtual Reality Mindfulness Meditation

Behavioral

An 8-minute guided breath meditation delivered via a Pico Neo 3 Head-Mounted Display using the Flow® application, set in an immersive virtual beach environment with custom Portuguese audio instruction.

Other names: VR+Med

Immersive Nature Virtual Reality

Behavioral

An 8-minute immersive virtual beach environment using the Flow® application on a Pico Neo 3 Head-Mounted Display, provided without any guided meditation or audio instruction.

Other names: VR only

Primary outcomes

  1. Number of Participants Who Complete the VR Intervention (Feasibility)

    Time frame: Day 1 -Immediately after the intervention (approximately 8 minutes)

    Feasibility is evaluated by the drop-off/discontinuation rate. The metric for success is a drop-off rate threshold of less than 10%.

  2. Acceptability Assessed by an Adapted Simulator Sickness Questionnaire (SSQ) Score

    Time frame: Immediately post-intervention (approximately 8 minutes from VR intervention start)

    Participant acceptability and tolerability are evaluated by measuring overall cybersickness. Participants rate four specific symptoms (nausea, dizziness, headache, and blurred vision) adapted from the Simulator Sickness Questionnaire (SSQ) on a visual analogue scale from 0-100. The scores for these four items are averaged to calculate a single overall mean score. The aggregated score ranges from 0 to 100, where a higher score indicates worse cybersickness. An aggregated score of < 25 is the pre-defined threshold for clinical acceptability.

Secondary outcomes

  1. Change in Pre-operative State Anxiety

    Time frame: Baseline (pre-intervention) to immediately post-intervention (approximately 8 minutes).

    Self-reported state anxiety levels assessed via a Visual Analogue Scale (VAS Anxious). Scores range from 0 to 100, where higher scores indicate worse/higher anxiety. Change is calculated as the post-intervention score minus the baseline score.

  2. Change in Surgery-Specific Fear

    Time frame: Baseline (pre-intervention) to immediately post-intervention (approximately 8 minutes).

    Self-reported procedural fear levels assessed via a Visual Analogue Scale (VAS Afraid). Scores range from 0 to 100, where higher scores indicate worse/higher fear. Change is calculated as the post-intervention score minus the baseline score.

  3. Change in Calmness Assessed by Visual Analogue Scale (VAS)

    Time frame: Baseline (pre-intervention) to immediately post-intervention (approximately 8 minutes).

    Evaluation of positive emotional shifts assessed via 0-100 Visual Analogue Scales for Calmness where higher scores indicate a increased calmness

  4. Change in Resting Heart Rate

    Time frame: Baseline (pre-intervention) to immediately post-intervention (approximately 8 minutes).

    Change Pre-post readings of Heart Rate (bpm), reported in beats per minute (bpm). Change is calculated as the post-intervention heart rate minus the baseline heart rate.

  5. Change in State Anxiety Assessed by the short Brazilian State Trait Anxiety Inventory (STAI-S)

    Time frame: Baseline to immediately post-intervention (approximately 8 minutes).

    Self-reported anxiety. Scores range from minimum 6 to maximum 24, where higher scores indicate worse/higher anxiety.

  6. Change in Optimism Assessed by Visual Analogue Scale (VAS)

    Time frame: Pre-intervention baseline to immediately post-intervention (approximately 8 minutes).

    Self-reported optimism levels. Scores range from 0 to 100, where higher scores indicate a better/more optimistic mood.

  7. Change in Systolic Blood Pressure

    Time frame: Pre-Intervention baseline to immediately post-intervention (approximately 8 minutes).

    Pre-post Clinical monitor tracking of Systolic Blood Pressure, reported in millimeters of mercury (mmHg). Change is calculated as the post-intervention mmHg value minus the baseline mmHg value.

  8. Change in Diastolic Blood Pressure

    Time frame: Pre-intervention baseline to immediately post-intervention (approximately 8 minutes).

    Pre-post Clinical monitor tracking of Diastolic Blood Pressure, reported in millimeters of mercury (mmHg). Change is calculated as the post-intervention mmHg value minus the baseline mmHg value.

Other outcomes

  1. Patient Sentiment Score Assessed by Word-Level Semantic Projection Analysis (Exploratory)

    Time frame: Post-Operative Day 1 - During post-operative surgical recovery.

    Subjective patient sentiment is evaluated via retrospective semi-structured interviews. Transcribed emotion words provided by the participant are quantified using a word-level semantic projection analysis via natural language embedding models. This analysis maps the participant's vocabulary onto a continuous, bi-polar "distress-to-relaxed" emotional axis, yielding a semantic projection score. Scores range from -1.0 to 1.0 where a higher score indicates greater alignment with the relaxed/relief pole (a better outcome), and a lower score indicates greater alignment with distress.

Sponsors and collaborators

Lead sponsor

Fundacao Champalimaud

Other

Registry information

Official study title

Comparing Immersive Mindfulness and Nature Interventions for Managing Preoperative Distress in Breast Cancer Patients: A Pilot Randomized Controlled Trial.

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 25, 2026
Registry last updated
Aug 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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