AnxietyNCT07463638
Mindfulness Intervention on Minimally Invasive Vascular Surgery
A study testing VR-Based Mindfulness Intervention in people with Anxiety and Pain, run by Tongji Hospital at 1 site in China.
Trial summary
The goal of this clinical trial is to learn whether a virtual reality (VR)-based mindfulness intervention can reduce anxiety and pain in adults undergoing minimally invasive surgery for lower-extremity varicose veins under local anesthesia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety, Pain, Varicose Veins of Lower Limb
- What is being tested?
- VR-Based Mindfulness Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- Oct 2026to Jul 2027
- 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
- Age ≥18 years.
- American Society of Anesthesiologists (ASA) physical status I-III.
- Clinically and imaging-confirmed superficial lower-extremity varicose veins with venous insufficiency and great saphenous vein involvement, with CEAP class C3-C5.
- Scheduled for elective minimally invasive surgery for lower-extremity varicose veins under local anesthesia.
- Willing and able to provide written informed consent.
- Able to complete the study procedures and follow-up assessments.
- No other severe systemic disease or surgical contraindication that may compromise surgical safety or materially interfere with interpretation of the study outcomes.
Who cannot join
- Cognitive impairment according to the prespecified study screening criterion (MMSE score ≤26).
- Unable to wear or use the VR device, including because of blindness or deafness.
- Previous history of the same type of varicose vein surgery.
- Acute or chronic pain unrelated to peripheral vascular disease.
- Oral opioid or nonsteroidal anti-inflammatory drug (NSAID) use within the previous 30 days.
- Pregnancy or breastfeeding.
- Current or previous participation in a psychological intervention.
- Previous mindfulness experience, a documented psychiatric history, or consultation with a trauma psychologist during the current hospitalization.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Mindfulness Intervention Based on Virtual Reality Technology on Anxiety and Pain in Minimally Invasive Vascular Surgery Under Local Anesthesia: a Single-center, Prospective, Randomized Controlled Clinical Study
The goal of this clinical trial is to learn whether a virtual reality (VR)-based mindfulness intervention can reduce anxiety and pain in adults undergoing minimally invasive surgery for lower-extremity varicose veins under local anesthesia. The study will also examine whether the intervention affects vital signs, fatigue, sleep quality, and patient satisfaction.
The main questions this study aims to answer are:
Read more
- Does VR-based mindfulness reduce patients' anxiety during surgery compared with routine psychological care?
- Does VR-based mindfulness reduce perioperative pain and improve other patient-reported and physiological outcomes? Researchers will compare a VR-based mindfulness intervention with routine psychological care. A total of 160 participants will be randomly assigned to one of the two groups.
Participants in the VR-based mindfulness group will:
- Receive an approximately 15-minute VR-based mindfulness session in the preoperative waiting area.
- Begin a VR-based mindfulness session at the start of surgery. Each intraoperative session lasts 25 minutes and may be repeated until the end of surgery.
Participants in the control group will receive routine psychological care before and during surgery.
Participants in both groups will:
- Complete assessments of state anxiety approximately 30 minutes before surgery, immediately before surgery, 25 minutes after the start of surgery, and after surgery. The 25-minute assessment corresponds to the completion of the first 25-minute intraoperative VR-based mindfulness session in the intervention group.
- Rate their pain before surgery and, at the end of surgery, report both their current pain intensity and the highest level of pain experienced during surgery.
- Have blood pressure and heart rate measured before surgery and monitored at regular intervals throughout surgery.
- Complete assessments of fatigue in the preoperative waiting area and again on the first postoperative day.
- Complete assessments of sleep quality in the preoperative waiting area and again on the first postoperative day.
- Complete a satisfaction assessment on the first postoperative day.
Read the detailed description
This is a single-center, prospective, open-label, parallel-group randomized controlled trial involving 160 adults undergoing elective minimally invasive surgery for lower-extremity varicose veins under local anesthesia. After eligibility is confirmed and written informed consent is obtained, participants will complete all prespecified baseline assessments before group allocation. Participants will then be randomly assigned in a 1:1 ratio to the VR-based mindfulness intervention group or the control group using block randomization with a fixed block size of 4. The randomization sequence will be generated using SAS version 9.4, and allocation will be concealed using sequentially numbered, opaque, sealed envelopes. After completion of the baseline assessments, a trained nurse will open the next envelope in numerical order and assign the participant according to the allocation indicated inside the envelope.
Participants in the intervention group will receive an approximately 15-minute VR-based mindfulness session in the preoperative waiting area. At the start of surgery, they will begin an intraoperative VR-based mindfulness session lasting 25 minutes. After completion of the first 25-minute session and the corresponding intraoperative assessment, the VR-based mindfulness intervention will be resumed and repeated in 25-minute sessions until the end of surgery. Participants in the control group will receive routine psychological care before and during surgery.
State anxiety will be assessed approximately 30 minutes before surgery, immediately before surgery, 25 minutes after the start of surgery, and at the end of surgery. The 25-minute intraoperative assessment corresponds to completion of the first 25-minute VR-based mindfulness session in the intervention group, with participants in the control group assessed at the corresponding time point. Additional outcomes include pain intensity, blood pressure, heart rate, fatigue, sleep quality, patient satisfaction, and duration of surgery.
- Conditions
- Anxiety, Pain, Varicose Veins of Lower Limb
- Being tested
- VR-Based Mindfulness Intervention
- Keywords
- Lower-Extremity Varicose Veins, Virtual Reality, Mindfulness, Local Anesthesia, Minimally Invasive Surgery, Perioperative Anxiety, Perioperative Pain
- Medical subject headings
- Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR-Based Mindfulness InterventionBehavioural
The VR-based mindfulness intervention will be delivered in two perioperative stages on the day of surgery. Approximately 30 minutes before surgery, participants assigned to the intervention group will be transferred to a dedicated room in the preoperative waiting area. A mindfulness-trained waiting-area nurse will assist participants in wearing Huawei VR Glass and receiving a prerecorded mindfulness theory course together with guided mindfulness Audio A for approximately 15 minutes. At the start of surgery, another mindfulness-trained research nurse will assist participants in wearing Huawei VR Glass and receiving prerecorded guided mindfulness Audio B. Each intraoperative session will last 25 minutes and will be repeated until the end of surgery.
| Study group | Role | What they receive |
|---|---|---|
| VR-Based Mindfulness Intervention | Experimental | Participants in the intervention group will receive routine psychological care plus a VR-based mindfulness intervention. On the day of surgery, participants will be transferred to the preoperative waiting area approximately 30 minutes before surgery and placed in a dedicated room. A mindfulness-trained nurse will assist the participant in wearing Huawei VR Glass and receiving a prerecorded mindfulness theory course together with guided mindfulness Audio A for approximately 15 minutes. After the participant enters the operating room, the intraoperative VR-based mindfulness intervention will begin at the start of surgery. Another mindfulness-trained research nurse will assist the participant in wearing Huawei VR Glass and receiving prerecorded guided mindfulness Audio B. Each intraoperative session will last 25 minutes and will be repeated until the end of surgery. Receives: Behavioral: VR-Based Mindfulness Intervention |
| Routine Psychological Care | No intervention | Participants in the control group will receive routine psychological care under the same medical conditions. Routine psychological care will include a preoperative visit providing information about the surgical procedure, expected outcomes, and other surgery-related information, as well as psychological support such as reassurance and encouragement. |
What is being measured
The primary outcome is the main question the study is designed to answer.
State-Trait Anxiety Inventory-State Subscale (STAI-State)
The STAI-State is a 20-item self-report measure of state anxiety. Each item is rated on a 4-point scale, yielding a total score ranging from 20 to 80. Higher scores indicate greater levels of state anxiety.
Measured: Approximately 30 min before surgery, immediately before surgery, 25 min after surgery starts, and at surgery end. The 25-min assessment follows the first VR mindfulness session in the intervention group; controls are assessed at the same time
Secondary outcomes (6)
Pain Intensity (Numeric Rating Scale, NRS)
Pain intensity will be assessed using the Numeric Rating Scale (NRS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable. At the end of surgery, participants will report both their highest pain experienced during surgery and their current pain intensity.
Measured: Approximately 30 min before surgery and at surgery end, when maximum intraoperative pain and current pain intensity will be assessed.
blood pressure
Systolic and diastolic blood pressure will be measured in mmHg using the perioperative patient monitor.
Measured: Approximately 30 min before surgery, immediately before surgery, and every 5 min from the start of surgery until the end of surgery.
Fatigue (Brief Fatigue Inventory, BFI)
Fatigue will be assessed using the 9-item Brief Fatigue Inventory (BFI). Each item is scored from 0 to 10, with higher scores indicating greater fatigue.
Measured: Upon arrival in the preoperative waiting area (baseline) and on postoperative day 1, assessing fatigue related to the day of surgery.
Sleep Quality (Leeds Sleep Evaluation Questionnaire, LSEQ)
Sleep quality will be assessed using the Leeds Sleep Evaluation Questionnaire (LSEQ), which includes 10 items across four domains: getting to sleep, sleep quality, awakening, and post-awakening state. Each item is rated on a 100-mm visual analogue scale.
Measured: Upon arrival in the preoperative waiting area (baseline) and on postoperative day 1.
Satisfaction scale
Each dimension is scored using a 5-point Likert scale ranging from " never" (1 point) to "very frequently or always" (5 points).Higher scores indicate greater patient satisfaction
Measured: 24 hours postoperatively (Day 1)
heart rate
Heart rate will be measured in beats per minute (bpm) using the perioperative patient monitor. Intraoperative values will be monitored every 5 minutes and automatically recorded by the monitoring system.
Measured: Approximately 30 min before surgery, immediately before surgery, and every 5 min from the start of surgery until the end of surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2026
- Study startOct 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wan Kuang, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07463638
- Sponsor's protocol ID
- TJHL01
- Status last verified
- Oct 2026
- First submitted
- 17 Nov 2025
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Westerlinck P, Maes N, Coucke P. Assessing the Effect of a Mobile Application on Cancer Risk Health Literacy: A Cross-Sectional Study Design. Appl Clin Inform. 2025 Mar;16(2):447-462. doi: 10.1055/a-2516-1757. Epub 2025 Jan 15.
PubMed 39814048Kivipelto M, Helkala EL, Laakso MP, Hanninen T, Hallikainen M, Alhainen K, Soininen H, Tuomilehto J, Nissinen A. Midlife vascular risk factors and Alzheimer's disease in later life: longitudinal, population based study. BMJ. 2001 Jun 16;322(7300):1447-51. doi: 10.1136/bmj.322.7300.1447.
PubMed 11408299Nowak A, Chmaj-Wierzchowska K, Kampioni M, Malinger A, Wilczak M. Evaluation of pain during diagnostic and surgical minihysteroscopy under local anesthesia. Arch Med Sci. 2023 Aug 17;21(2):463-470. doi: 10.5114/aoms/169979. eCollection 2025.
PubMed 40395882Gloviczki P, Lawrence PF, Wasan SM, Meissner MH, Almeida J, Brown KR, Bush RL, Di Iorio M, Fish J, Fukaya E, Gloviczki ML, Hingorani A, Jayaraj A, Kolluri R, Murad MH, Obi AT, Ozsvath KJ, Singh MJ, Vayuvegula S, Welch HJ. The 2023 Society for Vascular Surgery, American Venous Forum, and American Vein and Lymphatic Society clinical practice guidelines for the management of varicose veins of the lower extremities. Part II: Endorsed by the Society of Interventional Radiology and the Society for Vascular Medicine. J Vasc Surg Venous Lymphat Disord. 2024 Jan;12(1):101670. doi: 10.1016/j.jvsv.2023.08.011. Epub 2023 Aug 29.
PubMed 37652254Haridas Abhishek;Pawar Chandrashekara Rao Deepika;Ojha Moitri;Madhushree J.Assessment of pain and intraoperative anxiety by computerized and traditional local anesthetic methods in periodontal therapies: A comparative study[J].Journal of International Oral Health,2022.
Rodriguez VH, Medrano CT, Plaza I. Wearable Sensors for Measuring Movement in Short Sessions of Mindfulness Sitting Meditation: A Pilot Study. J Healthc Eng. 2018 May 7;2018:7275049. doi: 10.1155/2018/7275049. eCollection 2018.
PubMed 29854363Slomski A. Mindfulness Noninferior to Medication for Quelling Anxiety. JAMA. 2023 Jan 3;329(1):12. doi: 10.1001/jama.2022.23506. No abstract available.
PubMed 36594959Marinovic DA, Hunter RL. Examining the interrelationships between mindfulness-based interventions, depression, inflammation, and cancer survival. CA Cancer J Clin. 2022 Sep;72(5):490-502. doi: 10.3322/caac.21733. Epub 2022 Jun 16.
PubMed 35709081Garland E, Gaylord S, Park J. The role of mindfulness in positive reappraisal. Explore (NY). 2009 Jan-Feb;5(1):37-44. doi: 10.1016/j.explore.2008.10.001.
PubMed 19114262Cramer H, Lauche R, Paul A, Dobos G. Mindfulness-based stress reduction for breast cancer-a systematic review and meta-analysis. Curr Oncol. 2012 Oct;19(5):e343-52. doi: 10.3747/co.19.1016.
PubMed 23144582Foulk M, Montagnini M, Fitzgerald J, Ingersoll-Dayton B. Mindfulness-Based Group Therapy for Chronic Pain Management in Older Adults. Clin Gerontol. 2023 Jun 28:1-10. doi: 10.1080/07317115.2023.2229307. Online ahead of print.
PubMed 37378667Sharpe L, Richmond B, Menzies RE, Forrest D, Crombez G, Colagiuri B. A synthesis of meta-analyses of mindfulness-based interventions in pain. Pain. 2024 Jan 1;165(1):18-28. doi: 10.1097/j.pain.0000000000002997. Epub 2023 Aug 14.
PubMed 37578535Haisley KR, Straw OJ, Muller DT, Antiporda MA, Zihni AM, Reavis KM, Bradley DD, Dunst CM. Feasibility of implementing a virtual reality program as an adjuvant tool for peri-operative pain control; Results of a randomized controlled trial in minimally invasive foregut surgery. Complement Ther Med. 2020 Mar;49:102356. doi: 10.1016/j.ctim.2020.102356. Epub 2020 Feb 26.
PubMed 32147069O'Connor S, Mayne A, Hood B. Virtual Reality-Based Mindfulness for Chronic Pain Management: A Scoping Review. Pain Manag Nurs. 2022 Jun;23(3):359-369. doi: 10.1016/j.pmn.2022.03.013. Epub 2022 Apr 28.
PubMed 35491349Kaitlyn Delaney Chappell,Karen J. Goodman,Jean-Michel Le Mellédo, et al. Mo1104 VIRTUAL MINDFULNESS-BASED STRESS REDUCTION FOR ADULTS WITH INFLAMMATROY BOWEL DISEASE: FEASIBILITY TRIAL RESULTS. Gastroenterology. 2023;164 (6):S-756.
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Mindfulness Intervention Based on Virtual Reality Technology on Anxiety and Pain in Minimally Invasive Vascular Surgery Under Local Anesthesia: a Single-center, Prospective, Randomized Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT07463638
- Acronym / sponsor ID
- TJHL01
- Conditions
- Anxiety, Pain, Varicose Veins of Lower Limb
- Keywords
- Lower-Extremity Varicose Veins, Virtual Reality, Mindfulness, Local Anesthesia, Minimally Invasive Surgery, Perioperative Anxiety, Perioperative Pain
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 11 Mar 2026 (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 clinical trial is to learn whether a virtual reality (VR)-based mindfulness intervention can reduce anxiety and pain in adults undergoing minimally invasive surgery for lower-extremity varicose veins under local anesthesia. The study will also examine whether the intervention affects vital signs, fatigue, sleep quality, and patient satisfaction.
The main questions this study aims to answer are:
- Does VR-based mindfulness reduce patients' anxiety during surgery compared with routine psychological care?
- Does VR-based mindfulness reduce perioperative pain and improve other patient-reported and physiological outcomes? Researchers will compare a VR-based mindfulness intervention with routine psychological care. A total of 160 participants will be randomly assigned to one of the two groups.
Participants in the VR-based mindfulness group will:
- Receive an approximately 15-minute VR-based mindfulness session in the preoperative waiting area.
- Begin a VR-based mindfulness session at the start of surgery. Each intraoperative session lasts 25 minutes and may be repeated until the end of surgery.
Participants in the control group will receive routine psychological care before and during surgery.
Participants in both groups will:
- Complete assessments of state anxiety approximately 30 minutes before surgery, immediately before surgery, 25 minutes after the start of surgery, and after surgery. The 25-minute assessment corresponds to the completion of the first 25-minute intraoperative VR-based mindfulness session in the intervention group.
- Rate their pain before surgery and, at the end of surgery, report both their current pain intensity and the highest level of pain experienced during surgery.
- Have blood pressure and heart rate measured before surgery and monitored at regular intervals throughout surgery.
- Complete assessments of fatigue in the preoperative waiting area and again on the first postoperative day.
- Complete assessments of sleep quality in the preoperative waiting area and again on the first postoperative day.
- Complete a satisfaction assessment on the first postoperative day.
Detailed description
This is a single-center, prospective, open-label, parallel-group randomized controlled trial involving 160 adults undergoing elective minimally invasive surgery for lower-extremity varicose veins under local anesthesia. After eligibility is confirmed and written informed consent is obtained, participants will complete all prespecified baseline assessments before group allocation. Participants will then be randomly assigned in a 1:1 ratio to the VR-based mindfulness intervention group or the control group using block randomization with a fixed block size of 4. The randomization sequence will be generated using SAS version 9.4, and allocation will be concealed using sequentially numbered, opaque, sealed envelopes. After completion of the baseline assessments, a trained nurse will open the next envelope in numerical order and assign the participant according to the allocation indicated inside the envelope.
Participants in the intervention group will receive an approximately 15-minute VR-based mindfulness session in the preoperative waiting area. At the start of surgery, they will begin an intraoperative VR-based mindfulness session lasting 25 minutes. After completion of the first 25-minute session and the corresponding intraoperative assessment, the VR-based mindfulness intervention will be resumed and repeated in 25-minute sessions until the end of surgery. Participants in the control group will receive routine psychological care before and during surgery.
State anxiety will be assessed approximately 30 minutes before surgery, immediately before surgery, 25 minutes after the start of surgery, and at the end of surgery. The 25-minute intraoperative assessment corresponds to completion of the first 25-minute VR-based mindfulness session in the intervention group, with participants in the control group assessed at the corresponding time point. Additional outcomes include pain intensity, blood pressure, heart rate, fatigue, sleep quality, patient satisfaction, and duration of surgery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VR-Based Mindfulness Intervention | Experimental | Behavioral: VR-Based Mindfulness InterventionParticipants in the intervention group will receive routine psychological care plus a VR-based mindfulness intervention. On the day of surgery, participants will be transferred to the preoperative waiting area approximately 30 minutes before surgery and placed in a dedicated room. A mindfulness-trained nurse will assist the participant in wearing Huawei VR Glass and receiving a prerecorded mindfulness theory course together with guided mindfulness Audio A for approximately 15 minutes. After the participant enters the operating room, the intraoperative VR-based mindfulness intervention will begin at the start of surgery. Another mindfulness-trained research nurse will assist the participant in wearing Huawei VR Glass and receiving prerecorded guided mindfulness Audio B. Each intraoperative session will last 25 minutes and will be repeated until the end of surgery. |
| Routine Psychological Care | No intervention | –Participants in the control group will receive routine psychological care under the same medical conditions. Routine psychological care will include a preoperative visit providing information about the surgical procedure, expected outcomes, and other surgery-related information, as well as psychological support such as reassurance and encouragement. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥18 years.
- American Society of Anesthesiologists (ASA) physical status I-III.
- Clinically and imaging-confirmed superficial lower-extremity varicose veins with venous insufficiency and great saphenous vein involvement, with CEAP class C3-C5.
- Scheduled for elective minimally invasive surgery for lower-extremity varicose veins under local anesthesia.
- Willing and able to provide written informed consent.
Key exclusion criteria (8 listed)
- Cognitive impairment according to the prespecified study screening criterion (MMSE score ≤26).
- Unable to wear or use the VR device, including because of blindness or deafness.
- Previous history of the same type of varicose vein surgery.
- Acute or chronic pain unrelated to peripheral vascular disease.
- Oral opioid or nonsteroidal anti-inflammatory drug (NSAID) use within the previous 30 days.
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-Based Mindfulness InterventionThe VR-based mindfulness intervention will be delivered in two perioperative stages on the day of surgery. Approximately 30 minutes before surgery, participants assigned to the intervention group will be transferred to a dedicated room in the preoperative waiting area. A mindfulness-trained waiting-area nurse will assist participants in wearing Huawei VR Glass and receiving a prerecorded mindfulness theory course together with guided mindfulness Audio A for approximately 15 minutes. At the start of surgery, another mindfulness-trained research nurse will assist participants in wearing Huawei VR Glass and receiving prerecorded guided mindfulness Audio B. Each intraoperative session will last 25 minutes and will be repeated until the end of surgery. | Behavioural | VR-Based Mindfulness Intervention |
Primary outcome
State-Trait Anxiety Inventory-State Subscale (STAI-State)
Time frame: Approximately 30 min before surgery, immediately before surgery, 25 min after surgery starts, and at surgery end. The 25-min assessment follows the first VR mindfulness session in the intervention group; controls are assessed at the same time
The STAI-State is a 20-item self-report measure of state anxiety. Each item is rated on a 4-point scale, yielding a total score ranging from 20 to 80. Higher scores indicate greater levels of state anxiety.
6 secondary outcomes
Pain Intensity (Numeric Rating Scale, NRS)
Time frame: Approximately 30 min before surgery and at surgery end, when maximum intraoperative pain and current pain intensity will be assessed.
blood pressure
Time frame: Approximately 30 min before surgery, immediately before surgery, and every 5 min from the start of surgery until the end of surgery.
Fatigue (Brief Fatigue Inventory, BFI)
Time frame: Upon arrival in the preoperative waiting area (baseline) and on postoperative day 1, assessing fatigue related to the day of surgery.
Sleep Quality (Leeds Sleep Evaluation Questionnaire, LSEQ)
Time frame: Upon arrival in the preoperative waiting area (baseline) and on postoperative day 1.
Satisfaction scale
Time frame: 24 hours postoperatively (Day 1)
heart rate
Time frame: Approximately 30 min before surgery, immediately before surgery, and every 5 min from the start of surgery until the end of 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 7 Oct 2026.
- Background: PubMed 39814048Westerlinck P, Maes N, Coucke P. Assessing the Effect of a Mobile Application on Cancer Risk Health Literacy: A Cross-Sectional Study Design. Appl Clin Inform. 2025 Mar;16(2):447-462. doi: 10.1055/a-2516-1757. Epub 2025 Jan 15.
- Background: PubMed 11408299Kivipelto M, Helkala EL, Laakso MP, Hanninen T, Hallikainen M, Alhainen K, Soininen H, Tuomilehto J, Nissinen A. Midlife vascular risk factors and Alzheimer's disease in later life: longitudinal, population based study. BMJ. 2001 Jun 16;322(7300):1447-51. doi: 10.1136/bmj.322.7300.1447.
- Background: PubMed 40395882Nowak A, Chmaj-Wierzchowska K, Kampioni M, Malinger A, Wilczak M. Evaluation of pain during diagnostic and surgical minihysteroscopy under local anesthesia. Arch Med Sci. 2023 Aug 17;21(2):463-470. doi: 10.5114/aoms/169979. eCollection 2025.
- Background: PubMed 37652254Gloviczki P, Lawrence PF, Wasan SM, Meissner MH, Almeida J, Brown KR, Bush RL, Di Iorio M, Fish J, Fukaya E, Gloviczki ML, Hingorani A, Jayaraj A, Kolluri R, Murad MH, Obi AT, Ozsvath KJ, Singh MJ, Vayuvegula S, Welch HJ. The 2023 Society for Vascular Surgery, American Venous Forum, and American Vein and Lymphatic Society clinical practice guidelines for the management of varicose veins of the lower extremities. Part II: Endorsed by the Society of Interventional Radiology and the Society for Vascular Medicine. J Vasc Surg Venous Lymphat Disord. 2024 Jan;12(1):101670. doi: 10.1016/j.jvsv.2023.08.011. Epub 2023 Aug 29.
- BackgroundHaridas Abhishek;Pawar Chandrashekara Rao Deepika;Ojha Moitri;Madhushree J.Assessment of pain and intraoperative anxiety by computerized and traditional local anesthetic methods in periodontal therapies: A comparative study[J].Journal of International Oral Health,2022.
- Background: PubMed 29854363Rodriguez VH, Medrano CT, Plaza I. Wearable Sensors for Measuring Movement in Short Sessions of Mindfulness Sitting Meditation: A Pilot Study. J Healthc Eng. 2018 May 7;2018:7275049. doi: 10.1155/2018/7275049. eCollection 2018.
- Background: PubMed 36594959Slomski A. Mindfulness Noninferior to Medication for Quelling Anxiety. JAMA. 2023 Jan 3;329(1):12. doi: 10.1001/jama.2022.23506. No abstract available.
- Background: PubMed 35709081Marinovic DA, Hunter RL. Examining the interrelationships between mindfulness-based interventions, depression, inflammation, and cancer survival. CA Cancer J Clin. 2022 Sep;72(5):490-502. doi: 10.3322/caac.21733. Epub 2022 Jun 16.
- Background: PubMed 19114262Garland E, Gaylord S, Park J. The role of mindfulness in positive reappraisal. Explore (NY). 2009 Jan-Feb;5(1):37-44. doi: 10.1016/j.explore.2008.10.001.
- Background: PubMed 23144582Cramer H, Lauche R, Paul A, Dobos G. Mindfulness-based stress reduction for breast cancer-a systematic review and meta-analysis. Curr Oncol. 2012 Oct;19(5):e343-52. doi: 10.3747/co.19.1016.
- Background: PubMed 37378667Foulk M, Montagnini M, Fitzgerald J, Ingersoll-Dayton B. Mindfulness-Based Group Therapy for Chronic Pain Management in Older Adults. Clin Gerontol. 2023 Jun 28:1-10. doi: 10.1080/07317115.2023.2229307. Online ahead of print.
- Background: PubMed 37578535Sharpe L, Richmond B, Menzies RE, Forrest D, Crombez G, Colagiuri B. A synthesis of meta-analyses of mindfulness-based interventions in pain. Pain. 2024 Jan 1;165(1):18-28. doi: 10.1097/j.pain.0000000000002997. Epub 2023 Aug 14.
- Individual participant dataSharing planned: No
Related trials for Anxiety
Not yet recruiting
Building Resilience Through Anxiety Virtual Education in PICU Survivors
Critical Illness Recovery, Mental Health
Not yet recruiting
Mandala Coloring in Late Pregnancy
Pregnancy, Anxiety
Recruiting
Modulating Escape Using Focused Ultrasound
Anxiety Disorders
Not yet recruitingObservational study
Ecological Momentary Assessment of State-Dependent Decision-Making and Metacognition Across a Psychopathology Continuum
Depression, Anxiety
Recruiting
Stress and Anxiety Effects on Valuation
Reward Value Level
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VR-Based Mindfulness Intervention in people with Anxiety and Pain, run by Tongji Hospital at 1 site in China.
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 7 inclusion and 8 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 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Wan Kuang (13971596584, 714528069@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
State-Trait Anxiety Inventory-State Subscale (STAI-State) (time frame: Approximately 30 min before surgery, immediately before surgery, 25 min after surgery starts, and at surgery end. The 25-min assessment follows the first VR mindfulness session in the intervention group; controls are assessed at the same time). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07463638, which also lists 22 linked publications.
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 7 Oct 2026.