Clinical trial NCT06961695: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pain, Postoperative
Anxiety Preoperative
Keywords: Postoperative Pain
Mindfulness-Based Intervention
Pain Management
Chronic Pain Prevention
Virtual Reality
Lead sponsor: Babes-Bolyai University
Sponsor class: OTHER
Collaborators: name: Cluj-Napoca County Emergency Clinical Hospital, Surgery Department 2
First posted: 2025-05-08
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Primary outcomes:
measure: Change in Pain Intensity Measured by Brief Pain Inventory (BPI) .
timeFrame: 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).
measure: Change in Pain Intensity Measured by Numeric Rating Scale (NRS)
timeFrame: The NRS will be administered four times throughout the day following the surgery.
Secondary outcomes:
measure: Change in Anxiety Levels Measured by State-Trait Anxiety Inventory - State version (STAI-S)
timeFrame: 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).
measure: Change in Anxiety Levels Measured by State-Trait Anxiety Inventory - Trait version (STAI-T)
timeFrame: STAI-T will be administered preoperatively, on Day 1 of hospitalization.
measure: Change in Anxiety Levels Measured by Hospital Anxiety and Depression Scale (HADS).
timeFrame: Preoperative/Pre-intervention (Day 1 of hospitalization) Postoperative (Day 2, day of surgery) Follow-up (2 weeks after surgery)
Other outcomes:
measure: Change in Quality of Life Measured by EUROHIS-QOL.
timeFrame: Preoperative/Pre-intervention (Day 1 of hospitalization), Postoperative (Day 2, day of surgery), and Follow-up (2 weeks after surgery)
measure: Change in Sleep Quality Measured by Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Preoperative/Pre-intervention (Day 1 of hospitalization), Postoperative (Day 2, day of surgery), and Follow-up (2 weeks after surgery)
measure: Change in Emotional Balance Measured by the Equanimity Scale-16 (ES-16)
timeFrame: Preoperative/Pre-intervention (Day 1 of hospitalization), Postoperative (Day 2, day of surgery), and Follow-up (2 weeks after surgery)
measure: Change in Pain Catastrophizing Measured by the Pain Catastrophizing Scale (PCS)
timeFrame: Preoperative/Pre-intervention (Day 1 of hospitalization), Postoperative (Day 2, day of surgery), and Follow-up (2 weeks after surgery)
measure: Change in Mindful Attention and Awareness Measured by the Mindful Attention Awareness Scale (MAAS)
timeFrame: Immediately after the VR intervention (within 15 minutes).
measure: Screening for Cognitive Function Measured by the Montreal Cognitive Assessment (MoCA)
timeFrame: Pre-intervention (Day 1 of hospitalization), if cognitive impairment is suspected based on clinical observation.
measure: Presence Experience Measured by the Presence Questionnaire (PQ)
timeFrame: Immediately after the VR intervention (within 15 minutes).
measure: Simulator Sickness Symptoms Measured by Simulator Sickness Questionnaire (SSQ)
timeFrame: The SSQ will be administered immediately after the VR intervention (within 15 minutes)
Locations:
Study officials:
References: