Pain, PostoperativeVR-MindPainNCT06961695
The Efficacy of a Mindfulness-Based Virtual Reality Intervention to Reduce Pain in Postoperative Patients
A study testing VR Mindfulness-Based Relaxation in people with Pain, Postoperative and Anxiety Preoperative, run by Babes-Bolyai University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Postoperative, Anxiety Preoperative
- What is being tested?
- VR Mindfulness-Based Relaxation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- 12 May 2025to 5 Jul 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
About this study
Official title: Assessing the Effectiveness of a Mindfulness-Based Virtual Reality Intervention to Reduce Pain in Postoperative Patients: A Controlled Clinical Study
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:
Read more
- 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.
Read the 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:
- Experimental Group - Participants will receive a VR mindfulness-based relaxation intervention prior to surgery.
- 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:
- Before the intervention (Day 1)
- Immediately after the intervention (Day 1)
- After surgery (Day 2)
- 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
- Being tested
- VR Mindfulness-Based Relaxation
- Keywords
- Postoperative Pain, Mindfulness-Based Intervention, Pain Management, Chronic Pain Prevention, Virtual Reality
- Medical subject headings
- Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR Mindfulness-Based RelaxationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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)
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)
Measured: 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)
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.
Measured: STAI-T will be administered preoperatively, on Day 1 of hospitalization.
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)
Measured: Preoperative/Pre-intervention (Day 1 of hospitalization) Postoperative (Day 2, day of surgery) Follow-up (2 weeks after surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2025
- Study start12 May 2025 (estimated)
- Primary completion30 Jun 2025 (estimated)
- Study completion5 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Babes-Bolyai University
- Sponsor type
- University, hospital or other
- Collaborators
- Cluj-Napoca County Emergency Clinical Hospital, Surgery Department 2
- Responsible party
- Principal investigator, Roxana Cardos, Babes-Bolyai University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06961695
- Sponsor's protocol ID
- 6997/27.02.2025
- Acronym
- VR-MindPain
- Status last verified
- May 2025
- First submitted
- 16 Apr 2025
- Last updated
- 8 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Effectiveness of a Mindfulness-Based Virtual Reality Intervention to Reduce Pain in Postoperative Patients: A Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT06961695
- Acronym / sponsor ID
- VR-MindPain / 6997/27.02.2025
- Conditions
- Pain, Postoperative, Anxiety Preoperative
- Keywords
- Postoperative Pain, Mindfulness-Based Intervention, Pain Management, Chronic Pain Prevention, Virtual Reality
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Babes-Bolyai UniversityUniversity, hospital or other
- Collaborators
- Cluj-Napoca County Emergency Clinical Hospital, Surgery Department 2
- Study start
- 12 May 2025 (estimated)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 5 Jul 2025 (estimated)
- First posted
- 8 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- Experimental Group - Participants will receive a VR mindfulness-based relaxation intervention prior to surgery.
- 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:
- Before the intervention (Day 1)
- Immediately after the intervention (Day 1)
- After surgery (Day 2)
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VR Mindfulness Intervention Group | Experimental | Behavioral: VR Mindfulness-Based RelaxationParticipants 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. |
| 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VR Mindfulness-Based RelaxationVR 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. | Behavioural | VR Mindfulness Intervention Group |
Primary outcome
Change in Pain Intensity Measured by Brief Pain Inventory (BPI) .
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).
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)
Time frame: The NRS will be administered four times throughout the day following the surgery.
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.
3 secondary outcomes
Change in Anxiety Levels Measured by State-Trait Anxiety Inventory - State version (STAI-S)
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).
Change in Anxiety Levels Measured by State-Trait Anxiety Inventory - Trait version (STAI-T)
Time frame: STAI-T will be administered preoperatively, on Day 1 of hospitalization.
Change in Anxiety Levels Measured by Hospital Anxiety and Depression Scale (HADS).
Time frame: Preoperative/Pre-intervention (Day 1 of hospitalization) Postoperative (Day 2, day of surgery) Follow-up (2 weeks after surgery)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing VR Mindfulness-Based Relaxation in people with Pain, Postoperative and Anxiety Preoperative, run by Babes-Bolyai University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 May 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain Intensity Measured by Brief Pain Inventory (BPI) . (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).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2025.