Immersive Meditation for Managing Preoperative Distress.

NCT07785245 | Completed

• 1 other identifier: 2023012401
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Presurgical Distress

Keywords

Pre-surgical Distress; Breast Cancer; Virtual reality; Mindfulness

Outcome Measures

Primary Outcomes (2)

• Number of Participants Who Complete the VR Intervention (Feasibility)

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

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

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

  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.

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

Secondary Outcomes (8)

• Change in Pre-operative State Anxiety

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

• Change in Surgery-Specific Fear

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

• Change in Calmness Assessed by Visual Analogue Scale (VAS)

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

• Change in Resting Heart Rate

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

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

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

Other Outcomes (1)

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

  Post-Operative Day 1 - During post-operative surgical recovery.

Study Arms (3)

VR+meditation

EXPERIMENTAL

Participants experience an 8-minute guided breath meditation delivered via a Pico Neo 3 Head-Mounted Display using a customized study version of the Flow application set in an immersive virtual beach environment. Instruction audio is provided in Portuguese.

Behavioral: Immersive Virtual Reality Mindfulness Meditation

Nature VR only

ACTIVE COMPARATOR

Participants experience the identical 8-minute immersive virtual beach environment using the same hardware and application, but without any guided meditation or audio instruction, serving as a standard environmental VR distraction.

Behavioral: Immersive Nature Virtual Reality

Care as usual

NO INTERVENTION

Participants receive standard pre-operative surgical care in the holding room environment for an equivalent 8-minute period without VR exposure.

Interventions

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.

Also known as: VR+Med

VR+meditation

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.

Also known as: VR only

Nature VR only

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fundacao Champalimaud: lead

Study Sites (1)

Champalimaud Foundation - Breast Unit

Lisbon, Lisbon District, 1400-038, Portugal

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

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: August 13, 2026
• First Posted: August 25, 2026
• Study Start: January 31, 2024
• Primary Completion: March 30, 2025
• Study Completion: March 30, 2025
• Last Updated: August 25, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Data will be available beginning 6 months and ending 36 months following article publication.
• Access Criteria: Available to researchers who provide a methodologically sound proposal to achieve aims in the approved proposal.

Locations

PT (1)