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

Browse trials for

• Pain, Postoperative 5,043

Keywords

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

Study arms

• Experimental
  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.

  Behavioral: VR Mindfulness-Based Relaxation

• No intervention
  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)

Interventions

• BehavioralVR 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.

Primary outcomes

1. 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.

   Time frame: 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).

2. 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.

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

Secondary outcomes

1. 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)

   Time frame: 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).

2. 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.

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

3. 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)

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

Other outcomes

1. 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.

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

2. 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.

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

3. 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.

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

4. 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.

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

5. Change in Mindful Attention and Awareness Measured by the Mindful Attention Awareness Scale (MAAS)

   The Mindful Attention Awareness Scale (MAAS) is a validated instrument designed to assess individual differences in mindfulness, specifically the frequency of present-moment awareness and attention. It consists of 15 items, each rated on a 6-point Likert scale ranging from 1 (almost always) to 6 (almost never), with higher scores indicating greater mindfulness and present-moment awareness. Changes in MAAS scores will be analyzed to determine whether the VR mindfulness-based relaxation intervention enhances mindful awareness, potentially contributing to improved emotional regulation and pain perception.

   Time frame: Immediately after the VR intervention (within 15 minutes).

6. Screening for Cognitive Function Measured by the Montreal Cognitive Assessment (MoCA)

   Montreal Cognitive Assessment (MoCA) is a 30-point cognitive screening tool designed to detect mild cognitive impairment. The assessment evaluates multiple cognitive domains, including attention, concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. The test comprises various tasks that collectively contribute to the total score of 30 points. Administration time is approximately 10 minutes, and a score of 26 or above is generally considered normal.

   Time frame: Pre-intervention (Day 1 of hospitalization), if cognitive impairment is suspected based on clinical observation.

7. Presence Experience Measured by the Presence Questionnaire (PQ)

   The Presence Questionnaire (PQ) is a validated instrument designed to assess the degree to which individuals feel immersed and engaged in a virtual environment. It evaluates multiple dimensions of presence, including involvement, sensory fidelity, adaptation/immersion, and interface quality. The questionnaire consists of 32 items rated on a 7-point Likert scale, with higher scores indicating a stronger sense of presence. This measure will be used to explore how engagement in the VR mindfulness relaxation intervention influences participants' perception of presence and its potential relationship with anxiety reduction, pain perception, and psychological well-being.

   Time frame: Immediately after the VR intervention (within 15 minutes).

8. Simulator Sickness Symptoms Measured by Simulator Sickness Questionnaire (SSQ)

   The Simulator Sickness Questionnaire (SSQ) consists of 16 symptoms grouped into three components: Nausea (e.g., increased salivation, stomach awareness), Oculomotor (e.g., eyestrain, blurred vision), and Disorientation (e.g., dizziness, vertigo). Each symptom is rated on a 4-point Likert scale ranging from 0 (none) to 3 (severe). Subscale scores and a total score are calculated using standardized weighting formulas, with higher scores indicating more severe symptoms of simulator sickness.

   Time frame: The SSQ will be administered immediately after the VR intervention (within 15 minutes)