About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
VR Mindfulness-Based Relaxation
BehavioralVR 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 groups
Trial outcomes
Primary outcomes
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.
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.
Secondary outcomes
Change in Anxiety Levels Measured by State-Trait Anxiety Inventory - State version (STAI-S)
State-Trait Anxiety Inventory - state version (STAI-S) Measures state anxiety (how the participant feels "at this moment"). Contains 20 items rated on a 4-point Likert scale (from "Not at all" to "Very much"). The scores range between 20 (no anxiety) and 80 (high anxiety)
Change in Anxiety Levels Measured by State-Trait Anxiety Inventory - Trait version (STAI-T)
The STAI-T measures trait anxiety, referring to how the participant generally feels. It consists of 20 items rated on a 4-point Likert scale, ranging from "Almost never" to "Almost always." Total scores range from 20 to 80, with higher scores indicating greater levels of anxiety.
Change in Anxiety Levels Measured by Hospital Anxiety and Depression Scale (HADS).
Hospital Anxiety and Depression Scale (HADS): Evaluates anxiety and depression symptoms in hospitalized patients. Consists of 14 items divided into two subscales (anxiety and depression), each rated from 0 (absent) to 3 (severe). Total anxiety scores range from: 0-7 (normal) 8-10 (borderline abnormal) 11-21 (abnormal)
Other outcomes
Change in Quality of Life Measured by EUROHIS-QOL.
Quality of life will be assessed using the EUROHIS-QOL 8-Item Index, a validated short-form version of the WHOQOL-BREF, designed for rapid assessment of subjective well-being. EUROHIS-QOL Scale Details: Consists of 8 items covering four key domains: Physical health (e.g., energy levels, ability to perform daily activities) Psychological well-being (e.g., satisfaction with life, emotional balance) Social relationships (e.g., satisfaction with personal relationships) Environment (e.g., financial security, living conditions) Each item is rated on a 5-point Likert scale, where higher scores indicate better quality of life.
Change in Sleep Quality Measured by Pittsburgh Sleep Quality Index (PSQI)
SQI Scale Details: Consists of 19 items grouped into 7 components: Subjective sleep quality, Sleep latency (time taken to fall asleep), Sleep duration, Sleep efficiency, Sleep disturbances, Use of sleep medication, Daytime dysfunction. Each component is scored from 0 to 3, where higher scores indicate greater sleep impairment. The total PSQI score ranges from 0 to 21, with a score ≥5 indicating poor sleep quality.
Change in Emotional Balance Measured by the Equanimity Scale-16 (ES-16)
Emotional balance will be assessed using the Equanimity Scale-16 (ES-16), a validated self-report instrument designed to measure the ability to accept internal experiences (thoughts, emotions, bodily sensations) without reacting impulsively. ES-16 Scale Details: Contains 16 items divided into two subscales: Experiential acceptance - Measures the ability to acknowledge and accept emotional experiences. Non-reactivity - Assesses the capacity to refrain from impulsive reactions to emotions. Each item is rated on a Likert scale from 1 (strongly disagree) to 5 (strongly agree). Higher scores indicate greater emotional balance and equanimity.
Change in Pain Catastrophizing Measured by the Pain Catastrophizing Scale (PCS)
Pain catastrophizing will be assessed using the Pain Catastrophizing Scale (PCS), a self-report instrument designed to measure exaggerated negative responses to pain experiences. PCS Scale Details: Contains 13 items assessing three subdomains: Rumination - Persistent focus on pain-related thoughts. Magnification - Exaggeration of the perceived threat of pain. Helplessness - Feelings of being unable to manage pain. Items are rated on a Likert scale from 0 (never) to 4 (all the time). The total PCS score is obtained by summing individual item scores, with higher scores indicating greater pain catastrophizing.
Locations
Sponsors and contacts
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Babes-Bolyai University
Lead sponsor
Cluj-Napoca County Emergency Clinical Hospital, Surgery Department 2
Collaborator
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