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

NCT ID: NCT06961695

Last Updated: 2025-05-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-12
• Study Completion Date: 2025-07-05

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.

Conditions

Pain, Postoperative; Anxiety Preoperative

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

VR Mindfulness Intervention Group

Participants in this arm will undergo a structured protocol including a VR-based mindfulness intervention. Patients are guided through psychoeducation about mindfulness, and the VR procedure. Patients are invited to express their worries about the intervention or the surgery, which are normalized and addressed through reflective listening. The mindfulness session in VR lasts approximately 10 minutes and is supervised by the clinical psychologist.

A structured debriefing follows the VR session, using the 4Fs model:

Feelings: How did the patient feel during the session? Findings: Did they discover anything helpful or meaningful? Futures: How can they apply mindfulness during hospitalization or at home? Follow-up: They receive a home practice suggestion (4x4 breathing technique) connected to a meaningful thought, image, or feeling from the VR session.

Assesments at four time points.

Group Type: EXPERIMENTAL

VR Mindfulness-Based Relaxation

Intervention Type: BEHAVIORAL

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 engage in a brief, structured debriefing, during which they will reflect on what they felt, what they discovered, and how they can apply these insights during their hospital stay.

Participants will also be instructed to practice the 4-1-4 breathing technique three times per day during hospitalization. This technique involves inhaling for 4 seconds, holding the breath for 1 second, and exhaling for 4 seconds. It is intended to promote relaxation and support autonomic nervous system regulation.

Treatment as Usual (TAU) Group

Participants in this group will receive the standard preoperative and postoperative care provided by the hospital, without any additional intervention from the research team.

Assesments at 3 time points.

1. Before the intervention (Day 1)

2. After surgery (Day 2)

3. Two weeks after surgery (follow-up)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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 engage in a brief, structured debriefing, during which they will reflect on what they felt, what they discovered, and how they can apply these insights during their hospital stay.

Participants will also be instructed to practice the 4-1-4 breathing technique three times per day during hospitalization. This technique involves inhaling for 4 seconds, holding the breath for 1 second, and exhaling for 4 seconds. It is intended to promote relaxation and support autonomic nervous system regulation.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cluj-Napoca County Emergency Clinical Hospital, Surgery Department 2

UNKNOWN

Sponsor Role: collaborator

Babes-Bolyai University

OTHER

Sponsor Role: lead

Responsible Party

Roxana Cardos

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

6997/27.02.2025

Identifier Type: -

Identifier Source: org_study_id