The Efficacy of a Mindfulness-Based Virtual Reality Intervention to Reduce Pain in Postoperative Patients

Official title

Assessing the Effectiveness of a Mindfulness-Based Virtual Reality Intervention to Reduce Pain in Postoperative Patients: A Controlled Clinical Study

Overview

The goal of this randomized clinical trial is to evaluate whether a virtual reality (VR) mindfulness intervention can reduce anxiety and postoperative pain in adults undergoing surgery, primarily hernia and varicose vein procedures. The main research questions are: * Does a preoperative VR mindfulness intervention reduce anxiety before surgery? * Does this reduction in anxiety result in lower postoperative pain compared to usual care? * Does the intervention help prevent chronic pain two weeks after surgery? Researchers will compare a VR mindfulness intervention group with a treatment-as-usual (TAU) group to assess the intervention's effectiveness. Participants will: * Be randomly assigned to one of two groups: * Experimental group: Receive a VR mindfulness session on the first day of hospitalization (one day before surgery). * Control group: Receive standard hospital care (no intervention). * Complete psychological and pain assessments at four time points: 1. Before the intervention (Day 1) 2. Immediately after the intervention (only the experimental group, Day 1) 3. After surgery (Day 2) 4. Two weeks after surgery (follow-up) * Report pain intensity using the Numeric Rating Scale (NRS) at four postoperative time points. Before enrollment, participants will undergo a structured interview to assess eligibility. This study aims to determine whether reducing preoperative anxiety through VR mindfulness contributes to improved pain management and a lower risk of developing chronic pain following surgery.

Detailed description

Study Objective:

This study aims to assess the efficacy of a virtual reality (VR)-based mindfulness relaxation intervention in reducing preoperative anxiety, postoperative pain, and the risk of chronic pain two weeks after surgery.

Study Design:

This is a randomized controlled trial (RCT) comparing two groups:

1. Experimental Group - Participants will receive a VR mindfulness-based relaxation intervention prior to surgery. 2. Control Group - Participants will receive treatment as usual (TAU), with no additional intervention.

Intervention:

The VR mindfulness-based relaxation program will be administered on the day of hospitalization, one day prior to surgery.

The session will last 10-15 minutes and includes:

* A guided mindfulness exercise focused on breath awareness and relaxation. * A virtual beach environment designed to enhance calm and reduce anxiety. * A brief debriefing session following the second VR exposure (if applicable).

Assessments and Outcome Measures:

Structured psychological and pain assessments will be conducted at four time points:

1. Before the intervention (Day 1) 2. Immediately after the intervention (Day 1) 3. After surgery (Day 2) 4. Two weeks after surgery (follow-up)

Data Analysis:

* A Multivariate Analysis of Variance (MANOVA) with a mixed design (within-between interaction) will be used to assess differences across multiple dependent variables. * Repeated measures MANOVA will be applied to examine longitudinal changes and interactions between time and group.

Expected Impact:

This study seeks to determine whether reducing preoperative anxiety through a VR mindfulness intervention improves postoperative pain management and reduces the likelihood of developing chronic pain. If effective, the intervention could be integrated into routine preoperative care protocols to enhance patient outcomes and overall recovery experiences.

Interventions

• Behavioral VR Mindfulness-Based Relaxation
  VR Mindfulness-Based Relaxation is a behavioral intervention that utilizes a VR application designed to reduce anxiety and promote relaxation. Participants in the experimental group will undergo a single VR session, scheduled on the day of hospital admission (one day prior to surgery). The session lasts approximately 10 minutes and features an immersive beach environment combined with an audio-guided mindfulness exercise focused on breath awareness. Following the session, participants will enga

Primary outcome measures

• Change in Pain Intensity Measured by Brief Pain Inventory (BPI) . [Time frame: The BPI will be administered at three time points: preoperatively (Day 1 of hospitalization), postoperatively (Day 2, the day of surgery), and at follow-up (2 weeks after surgery).]
• Change in Pain Intensity Measured by Numeric Rating Scale (NRS) [Time frame: The NRS will be administered four times throughout the day following the surgery.]

Secondary outcome measures (3)

• Change in Anxiety Levels Measured by State-Trait Anxiety Inventory - State version (STAI-S) [Time frame: STAI-S measures will be administered: Preoperative/Pre-intervention (Day 1 of hospitalization) Post-intervention (Day 1, within 15 minutes after the VR session), Postoperative (Day 2, day of surgery), Follow-up (2 weeks after surgery).]
• Change in Anxiety Levels Measured by State-Trait Anxiety Inventory - Trait version (STAI-T) [Time frame: STAI-T will be administered preoperatively, on Day 1 of hospitalization.]
• Change in Anxiety Levels Measured by Hospital Anxiety and Depression Scale (HADS). [Time frame: Preoperative/Pre-intervention (Day 1 of hospitalization) Postoperative (Day 2, day of surgery) Follow-up (2 weeks after surgery)]

Eligibility criteria

Inclusion criteria

• The participant is scheduled for surgery and is currently hospitalized for hernia or varicose vein procedures.
• The participant is on the hospital's surgical waiting list.
• The participant is willing and able to provide informed consent.
• The participant agrees to participate in the study and to complete all required assessments during hospitalization and at follow-up (either at home or during post-operative medical visits).

Exclusion criteria

• Inability to provide informed consent due to mental incompetence (e.g., intellectual disability, dementia); mild cognitive impairment does not constitute an exclusion criterion.
• Limited proficiency in the Romanian language.
• Active substance use or alcohol use disorders that, in the opinion of the investigators, may interfere with participation.
• History of motion sickness.
• Severe visual impairment (e.g., inability to see clearly without glasses); patients who use contact lenses are not excluded.
• Use of strong opioids (e.g., morphine).
• Current suicide risk.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06961695 · 6997/27.02.2025

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗