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

NCT06961695 | Not Yet Recruiting

• 1 other identifier: 6997/27.02.2025
• Study Type: interventional
• Target: 64
• Locations: 0 countries
• Sites: N/A

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:
• Before the intervention (Day 1)
• Immediately after the intervention (only the experimental group, Day 1)
• After surgery (Day 2)
• 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.

Conditions

Pain, Postoperative; Anxiety Preoperative

Keywords

Postoperative Pain; Mindfulness-Based Intervention; Pain Management; Chronic Pain Prevention; Virtual Reality

Outcome Measures

Primary Outcomes (2)

• Change in Pain Intensity Measured by Brief Pain Inventory (BPI) .

  This tool assesses both pain intensity and its impact on daily functioning (e.g., sleep, work, social interactions). The BPI consists of 9 items, each rated on a 0-10 scale, where 0 indicates no pain or interference and 10 represents the worst possible pain or interference.

  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)

  Participants will rate their pain intensity on a 0-10 scale, where 0 indicates no pain and 10 represents the worst imaginable pain. NRS assessments will be conducted at four postoperative time points. This approach helps minimize the influence of analgesics and anesthetics on reported pain levels. By spreading out the measurements, we reduce the risk that a single time point reflects only the temporary effects of medication, thus allowing for more reliable and valid comparisons between treatment groups.

  The NRS will be administered four times throughout the day following the surgery.

Secondary Outcomes (3)

• Change in Anxiety Levels Measured by State-Trait Anxiety Inventory - State version (STAI-S)

  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)

  STAI-T will be administered preoperatively, on Day 1 of hospitalization.

• Change in Anxiety Levels Measured by Hospital Anxiety and Depression Scale (HADS).

  Preoperative/Pre-intervention (Day 1 of hospitalization) Postoperative (Day 2, day of surgery) Follow-up (2 weeks after surgery)

Other Outcomes (8)

• Change in Quality of Life Measured by EUROHIS-QOL.

  Preoperative/Pre-intervention (Day 1 of hospitalization), Postoperative (Day 2, day of surgery), and Follow-up (2 weeks after surgery)

• Change in Sleep Quality Measured by Pittsburgh Sleep Quality Index (PSQI)

  Preoperative/Pre-intervention (Day 1 of hospitalization), Postoperative (Day 2, day of surgery), and Follow-up (2 weeks after surgery)

• Change in Emotional Balance Measured by the Equanimity Scale-16 (ES-16)

  Preoperative/Pre-intervention (Day 1 of hospitalization), Postoperative (Day 2, day of surgery), and Follow-up (2 weeks after surgery)

Study Arms (2)

VR Mindfulness Intervention Group

EXPERIMENTAL

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.

Behavioral: VR Mindfulness-Based Relaxation

Treatment as Usual (TAU) Group

NO INTERVENTION

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)

Interventions

VR Mindfulness-Based Relaxation 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.

VR Mindfulness Intervention Group

Eligibility Criteria

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

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Babes-Bolyai University: lead
• Cluj-Napoca County Emergency Clinical Hospital, Surgery Department 2: collaborator

MeSH Terms

Conditions

Pain, Postoperative; Agnosia

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 16, 2025
• First Posted: May 8, 2025
• Study Start: May 12, 2025
• Primary Completion: June 30, 2025
• Study Completion: July 5, 2025
• Last Updated: May 8, 2025

Record last verified: 2025-05