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

NCT06961695 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2025-05-08

No results posted yet for this study

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.

Conditions

  • Pain, Postoperative
  • Anxiety Preoperative

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 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.

Sponsors & Collaborators

  • Cluj-Napoca County Emergency Clinical Hospital, Surgery Department 2

    collaborator UNKNOWN

  • Babes-Bolyai University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-12
Primary Completion
2025-06-30
Completion
2025-07-05

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06961695 on ClinicalTrials.gov