Acute Postoperative PainVR-TSPNCT06574451
Effectiveness and Safety of Adjuvant Software Based on Virtual Reality for Post-thoracoscopic Surgery Pain
A study testing VR-assisted postoperative analgesia in people with Acute Postoperative Pain and Video-assisted Thoracic Surgery, run by Guangdong Provincial People's Hospital at 4 sites in China.
Trial summary
A randomized controlled, prospective, multicenter, open label, superiority trial aims to evaluate the effectiveness and safety of adjuvant software based on virtual reality for post-thoracoscopic surgery pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Postoperative Pain, Video-assisted Thoracic Surgery, Virtual Reality
- What is being tested?
- VR-assisted postoperative analgesia
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 215 participants
- Where
- 4 sitesChina
- Study dates
- 22 Apr 2023to 24 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- 1.Age greater than or equal to 18 years.
- 2.Patients within 1 day after thoracoscopic surgery.
- 3.Junior high school degree or above, Mandarin communication is unimpeded, with certain Internet knowledge and mobile phone reading and writing skills.
- 4.The score of the numeric grading scale (NRS) at 24 hours postoperatively ≥ 4 points.
- 5.Patients who are able to understand the purpose of the study, voluntarily participate in and sign the informed consent form, and are willing to complete the follow-up as required by the protocol.
Who cannot join
- 1.Patients with severe cognitive impairment.
- 2.Patients with a previous diagnosis of epilepsy, dementia, migraine, or other neurological disease that may result in the inability to use postoperative analgesic adjuvant therapy software or that may have adverse effects.
- 3.Patients who are unable to understand or speak Mandarin.
- 4.Patients who have visual abnormalities, severe hearing impairment, or motion sickness, etc., and are unable to view VR.
- 5.Patients with trauma to the eyes, face, or neck that prevents the comfortable use of the VR device.
- 6.Patients with severe heart, liver, kidney, hematologic, digestive, nervous system diseases and malnutrition.
Show all 13Show fewer
- 7.Patients who have previously used virtual reality software for pain that has not responded to treatment.
- 8.Patients with a history of severe alcohol abuse, long-term heavy drinking, and symptoms of alcohol dependence.
- 9.Patients who have participated in any analgesic interventional study within the past 1 week.
- 10.Females who are pregnant or plan to become pregnant during the study.
- 11.The patient or their immediate family member works for a digital health or pharmaceutical company for acute or chronic pain treatment.
- 12.Patients who are unable to use electronic devices such as smartphones.
- 13.Other conditions that the investigator considers inappropriate for participation in a clinical trial.
Trial locations and contacts
4 sites in 1 country.
China4 sites, 4 recruiting
- Recruiting
Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences
Guangzhou, Guangdong, 510080
Wen-zhao Zhong, PhD, +86 20 83827812 ext. 51221, syzhongwenzhao@scut.edu.cn
Ben-Yuan Jiang, PhD, +8618613025014, jiangben1000@126.com
- Recruiting
Maoming People's Hospital
Maoming, Guangdong
Zhi-Qiang Luo
Xiao-Yang Su
- Recruiting
Ruijing Hospital, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality
He-Cheng Li, PhD
Guo Wei
- Recruiting
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality
Song Xu, PhD
Fan Ren, PhD
About this study
Official title: Effectiveness and Safety of Adjuvant Software Based on Virtual Reality for Post-thoracoscopic Surgery Pain (VR-TSP)
A randomized controlled, prospective, multicenter, open label, superiority trial aims to evaluate the effectiveness and safety of adjuvant software based on virtual reality for post-thoracoscopic surgery pain.
Read the detailed description
215 eligible patients will be enrolled. All enrolled patients will have an NRS score at 24 hours postoperatively, and those with a score greater than or equal to 4 will be randomly assigned to the test and control groups.
Patients in the experimental group will receive postoperative analgesic adjunctive therapy software to assist in pain control, with one postoperative analgesic adjunctive therapy software intervention at 24 hours and 48 hours after surgery, and pain evaluation within 30 minutes.
The control group will not experience postoperative analgesic adjuvant therapy software and will only record the pain level within 30 minutes. Subjects will complete a study summary form upon completion of follow-up.
All participants will receive intravenous analgesics pumped with mechanical pumps (analgesic pumps: Flurbiprofen cilexil Injection 5ml: 50mg/stick*4 sticks, combined with Dezocine Injection 1ml: 5mg/stick*6 sticks, add Ondansetron Hydrochloride Injection: 2ml: 4mg/stick*2 sticks; or add Tolisetron Mesylate Injection: 2ml: 6 mg/stick*4 sticks, diluted to 100mL with 0.9% sodium chloride injection).In case of an outbreak of pain (when analgesic pump is ineffective and the pain is unbearable), analgesic medication regimen: flurbiprofen cilofen injection (5 ml): 50 mg/piece, intravenous injection.
- Being tested
- VR-assisted postoperative analgesia
- Keywords
- Acute Postoperative Pain, VATS, VR
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR-assisted postoperative analgesiaDevice
Patients will receive postoperative analgesic adjunctive therapy software to assist in pain control, with one postoperative analgesic adjunctive therapy software intervention at 24 hours and 48 hours after surgery, and pain evaluation within 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| VR-assisted postoperative analgesia group | Experimental | Patients will receive postoperative analgesic adjunctive therapy software to assist in pain control, with one postoperative analgesic adjunctive therapy software intervention at 24 hours and 48 hours after surgery, and pain evaluation within 30 minutes.
All participants will receive intravenous analgesics pumped with mechanical pumps (analgesic pumps: Flurbiprofen cilexil Injection 5ml: 50mg/stick*4 sticks, combined with Dezocine Injection 1ml: 5mg/stick*6 sticks, add Ondansetron Hydrochloride Injection: 2ml: 4mg/stick*2 sticks; or add Tolisetron Mesylate Injection: 2ml: 6 mg/stick*4 sticks, diluted to 100mL with 0.9% sodium chloride injection).In case of an outbreak of pain (when analgesic pump is ineffective and the pain is unbearable), analgesic medication regimen: flurbiprofen cilofen injection 5 ml: 50 mg/piece, intravenous injection. Receives: Device: VR-assisted postoperative analgesia |
| Non-VR-assisted analgesia group | No intervention | The control group will not experience postoperative analgesic adjuvant therapy software and will only record the pain level within 30 minutes at 24 hours and 48 hours after surgery. All participants will receive intravenous analgesics pumped with mechanical pumps (analgesic pumps: Flurbiprofen cilexil Injection 5ml: 50mg/stick*4 sticks, combined with Dezocine Injection 1ml: 5mg/stick*6 sticks, add Ondansetron Hydrochloride Injection: 2ml: 4mg/stick*2 sticks; or add Tolisetron Mesylate Injection: 2ml: 6 mg/stick*4 sticks, diluted to 100mL with 0.9% sodium chloride injection).In case of an outbreak of pain (when analgesic pump is ineffective and the pain is unbearable), analgesic medication regimen: flurbiprofen cilofen injection 5 ml: 50 mg/piece, intravenous injection. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Rating Scale (NRS)
The NRS score is a commonly used postoperative pain assessment tool. The score uses a numeric scale from 0 to 10, on which patients are asked to mark their level of pain, with 0 being no pain and 10 being the most severe pain.
Measured: The NRS evaluation is within 30 minutes of 24 and 48 hours after surgery.
Secondary outcomes (2)
Incidence of adverse events
Any unfavorable medical occurrence during the course of the study, whether device-related or not, is an adverse event.
Measured: Assessment of adverse events is completed within 2 days postoperatively
Incidence of serious adverse events
If an event occurs during the clinical study that results in death or serious deterioration of health status, it is judged to be a serious adverse event
Measured: Assessment of serious adverse events is completed within 2 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2024
- Study start22 Apr 2023
- Primary completion24 Apr 2025 (estimated)
- Study completion24 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Postoperative PainStudies 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
- None (open label)
- Enrolment
- 215 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Guang Dong Liang Zi Health Consulting Co., Ltd, Guang Dong, China., Tianjin Medical University General Hospital, Ruijin Hospital, Maoming People's Hospital
- Responsible party
- Sponsor
- Investigators
- Wen-Zhao Zhong, Principal investigator, Guangdong Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06574451
- Sponsor's protocol ID
- VR-TSP
- Acronym
- VR-TSP
- Status last verified
- Apr 2024
- First submitted
- 25 Aug 2024
- Last updated
- 28 Aug 2024
- 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 28 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of Adjuvant Software Based on Virtual Reality for Post-thoracoscopic Surgery Pain (VR-TSP)
- ClinicalTrials.gov ID
- NCT06574451
- Acronym / sponsor ID
- VR-TSP / VR-TSP
- Keywords
- Acute Postoperative Pain, VATS, VR
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 215 participants (estimated)
- Lead sponsor
- Guangdong Provincial People's HospitalUniversity, hospital or other
- Collaborators
- Guang Dong Liang Zi Health Consulting Co., Ltd, Guang Dong, China., Tianjin Medical University General Hospital, Ruijin Hospital, Maoming People's Hospital
- Study start
- 22 Apr 2023 (actual)
- Primary completion
- 24 Apr 2025 (estimated)
- Study completion
- 24 Apr 2025 (estimated)
- First posted
- 28 Aug 2024 (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.
A randomized controlled, prospective, multicenter, open label, superiority trial aims to evaluate the effectiveness and safety of adjuvant software based on virtual reality for post-thoracoscopic surgery pain.
Detailed description
215 eligible patients will be enrolled. All enrolled patients will have an NRS score at 24 hours postoperatively, and those with a score greater than or equal to 4 will be randomly assigned to the test and control groups.
Patients in the experimental group will receive postoperative analgesic adjunctive therapy software to assist in pain control, with one postoperative analgesic adjunctive therapy software intervention at 24 hours and 48 hours after surgery, and pain evaluation within 30 minutes.
The control group will not experience postoperative analgesic adjuvant therapy software and will only record the pain level within 30 minutes. Subjects will complete a study summary form upon completion of follow-up.
All participants will receive intravenous analgesics pumped with mechanical pumps (analgesic pumps: Flurbiprofen cilexil Injection 5ml: 50mg/stick*4 sticks, combined with Dezocine Injection 1ml: 5mg/stick*6 sticks, add Ondansetron Hydrochloride Injection: 2ml: 4mg/stick*2 sticks; or add Tolisetron Mesylate Injection: 2ml: 6 mg/stick*4 sticks, diluted to 100mL with 0.9% sodium chloride injection).In case of an outbreak of pain (when analgesic pump is ineffective and the pain is unbearable), analgesic medication regimen: flurbiprofen cilofen injection (5 ml): 50 mg/piece, intravenous injection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VR-assisted postoperative analgesia group | Experimental | Device: VR-assisted postoperative analgesiaPatients will receive postoperative analgesic adjunctive therapy software to assist in pain control, with one postoperative analgesic adjunctive therapy software intervention at 24 hours and 48 hours after surgery, and pain evaluation within 30 minutes. All participants will receive intravenous analgesics pumped with mechanical pumps (analgesic pumps: Flurbiprofen cilexil Injection 5ml: 50mg/stick*4 sticks, combined with Dezocine Injection 1ml: 5mg/stick*6 sticks, add Ondansetron Hydrochloride Injection: 2ml: 4mg/stick*2 sticks; or add Tolisetron Mesylate Injection: 2ml: 6 mg/stick*4 sticks, diluted to 100mL with 0.9% sodium chloride injection).In case of an outbreak of pain (when analgesic pump is ineffective and the pain is unbearable), analgesic medication regimen: flurbiprofen cilofen injection 5 ml: 50 mg/piece, intravenous injection. |
| Non-VR-assisted analgesia group | No intervention | –The control group will not experience postoperative analgesic adjuvant therapy software and will only record the pain level within 30 minutes at 24 hours and 48 hours after surgery. All participants will receive intravenous analgesics pumped with mechanical pumps (analgesic pumps: Flurbiprofen cilexil Injection 5ml: 50mg/stick*4 sticks, combined with Dezocine Injection 1ml: 5mg/stick*6 sticks, add Ondansetron Hydrochloride Injection: 2ml: 4mg/stick*2 sticks; or add Tolisetron Mesylate Injection: 2ml: 6 mg/stick*4 sticks, diluted to 100mL with 0.9% sodium chloride injection).In case of an outbreak of pain (when analgesic pump is ineffective and the pain is unbearable), analgesic medication regimen: flurbiprofen cilofen injection 5 ml: 50 mg/piece, intravenous injection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 1.Age greater than or equal to 18 years.
- 2.Patients within 1 day after thoracoscopic surgery.
- 3.Junior high school degree or above, Mandarin communication is unimpeded, with certain Internet knowledge and mobile phone reading and writing skills.
- 4.The score of the numeric grading scale (NRS) at 24 hours postoperatively ≥ 4 points.
- 5.Patients who are able to understand the purpose of the study, voluntarily participate in and sign the informed consent form, and are willing to complete the follow-up as required by the protocol.
Key exclusion criteria (13 listed)
- 1.Patients with severe cognitive impairment.
- 2.Patients with a previous diagnosis of epilepsy, dementia, migraine, or other neurological disease that may result in the inability to use postoperative analgesic adjuvant therapy software or that may have adverse effects.
- 3.Patients who are unable to understand or speak Mandarin.
- 4.Patients who have visual abnormalities, severe hearing impairment, or motion sickness, etc., and are unable to view VR.
- 5.Patients with trauma to the eyes, face, or neck that prevents the comfortable use of the VR device.
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-assisted postoperative analgesiaPatients will receive postoperative analgesic adjunctive therapy software to assist in pain control, with one postoperative analgesic adjunctive therapy software intervention at 24 hours and 48 hours after surgery, and pain evaluation within 30 minutes. | Device | VR-assisted postoperative analgesia group |
Primary outcome
Numeric Rating Scale (NRS)
Time frame: The NRS evaluation is within 30 minutes of 24 and 48 hours after surgery.
The NRS score is a commonly used postoperative pain assessment tool. The score uses a numeric scale from 0 to 10, on which patients are asked to mark their level of pain, with 0 being no pain and 10 being the most severe pain.
2 secondary outcomes
Incidence of adverse events
Time frame: Assessment of adverse events is completed within 2 days postoperatively
Incidence of serious adverse events
Time frame: Assessment of serious adverse events is completed within 2 days postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2024.
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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. This study is not recruiting at the moment.
Wen-Zhao Zhong principal investigator
Guangdong Provincial People's Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VR-assisted postoperative analgesia in people with Acute Postoperative Pain and Video-assisted Thoracic Surgery, run by Guangdong Provincial People's Hospital at 4 sites 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 5 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 28 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wen-Zhao Zhong (+86-13609777314, syzhongwenzhao@scut.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Rating Scale (NRS) (time frame: The NRS evaluation is within 30 minutes of 24 and 48 hours after surgery.). 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 28 Aug 2024.