Presurgical Distress
Conditions
Keywords
Pre-surgical Distress, Breast Cancer, Virtual reality, Mindfulness
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALImmersive Virtual Reality Mindfulness Meditation
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.
BEHAVIORALImmersive Nature Virtual Reality
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.
Sponsors
Fundacao Champalimaud
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Complete the VR Intervention (Feasibility) | 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%. |
| Acceptability Assessed by an Adapted Simulator Sickness Questionnaire (SSQ) Score | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Pre-operative State Anxiety | 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. |
| Change in Surgery-Specific Fear | 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. |
| Change in Calmness Assessed by Visual Analogue Scale (VAS) | 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 |
| Change in Resting Heart Rate | 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. |
| Change in State Anxiety Assessed by the short Brazilian State Trait Anxiety Inventory (STAI-S) | 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. |
| Change in Optimism Assessed by Visual Analogue Scale (VAS) | 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. |
| Change in Systolic Blood Pressure | 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. |
| Change in Diastolic Blood Pressure | 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. |
Countries
Portugal
Outcome results
None listed