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. 2025 Aug 13;26:290. doi: 10.1186/s13063-025-08975-8

Effectiveness and safety of adjuvant software based on virtual reality for post-thoracoscopic surgery pain: study protocol for a randomized controlled trial

Xijia Feng 1,#, Wei Guo 1,#, Benyuan Jiang 2,#, Tong Li 3,#, Yi Lu 4, Song Xu 3,✉, Wenzhao Zhong 2,✉, Hecheng Li 1,✉
PMCID: PMC12351908  PMID: 40804646

Abstract

Background

Postoperative pain can significantly impair functional recovery and diminish the quality of life in patients who have undergone thoracoscopic surgery. Virtual reality (VR), by leveraging cognitive-behavioral intervention techniques and redirecting attention from noxious stimuli, holds promise as a modality to alleviate postoperative pain. Despite this potential, current VR software for postoperative care predominantly emphasizes physical therapy and rehabilitation, often overlooking the integration of pain management strategies. The primary objective of our study is to evaluate the effectiveness and safety of an adjunctive VR-based software for pain control following thoracoscopic surgery.

Methods

This is a prospective, multicenter, open-label, randomized controlled trial involving 215 patients who have undergone thoracoscopic surgery. Participants will be randomly allocated to one of two parallel groups. The experimental group will receive postoperative adjuvant analgesic software in addition to standard postoperative pharmacological analgesia, while the control group will receive only standard postoperative pharmacological analgesia. Pain intensity will be assessed using the numerical rating scale (NRS) at pre-intervention and at 24 and 48 h post-surgery. The primary outcome measure will be the effectiveness of the VR-based adjuvant analgesic software, as assessed by the reduction in NRS scores after the second intervention at 48 h postoperatively compared to pre-intervention baseline at 24 h postoperatively, and the secondary outcome measure will assess its safety profile.

Discussion

Our study marks a pioneering effort to incorporate VR-based adjuvant software into the postoperative pain management regimen. We endeavor to explore an innovative approach to deliver evidence-based pain treatments. The findings of this trial aim to shed light on the potential benefits of VR as a complementary tool to traditional analgesic therapies in the context of postoperative pain management following thoracoscopic procedures.

Trial registration

Our protocol was retrospectively registered in the Chinese Clinical Trial Registry on August 2, 2024. The registration number was ChiCTR2400087741.

Keywords: Thoracoscopic surgery, Virtual reality, Adjuvant software, Pain control

Background

Pain is a multifaceted and challenging experience that significantly impacts patients following surgical procedures [1]. This discomfort arises primarily from the activation of nociceptive somatic afferents, particularly from the intercostal nerves, due to injuries sustained to the chest wall and pleura. Pain signals are transmitted to the ipsilateral dorsal horn of the spinal cord and ascend to the limbic system and somatosensory cortices through the contralateral anterolateral system [2, 3]. Inadequate management of postoperative pain can result in adverse consequences, including impaired functional recovery, increased morbidity, diminished quality of life, and a higher risk of developing chronic pain [4, 5].

In the realm of postoperative care, pain management typically involves pharmacological measures such as anesthetics and analgesics aimed at alleviating the physiological reactions contributing to pain [6]. Opioids have historically been a preferred option for managing postoperative discomfort; however, their associated adverse effects—including nausea, vomiting, itching, and respiratory depression—can limit the ability to administer effective dosages, thus potentially hindering recovery. The transactivation of vascular endothelial growth factor receptors and increased expression of opioid receptors indicate a potential connection between opioid prescription and cancer outcomes, including enhanced tumor development, angiogenesis, and distant dissemination [7–9]. Opioids may heighten the likelihood of drug dependency, making the opioid epidemic perhaps the most significant public health catastrophe the USA has ever encountered. During the year 2015, a total of 52,000 individuals succumbed to drug overdoses, out of which more than 30,000 fatalities were attributed to opioid substances in the USA [10]. Numerous individuals who abuse opioids develop an addiction after beginning treatment with lawful, doctor-prescribed medications [11]. Patients’ apprehensions regarding the potential for dependence on pain medicines might also result in suboptimal pain treatment.

Integrating cutting-edge methods into a multimodal analgesic approach is essential for controlling pain, alleviating anxiety, and promoting patient recuperation following surgery [1]. Non-pharmacological interventions such as acupuncture, relaxation techniques, music therapy, hypnosis, and transcutaneous nerve stimulation should be regarded as additional options or alternatives to traditional pain-relieving treatments. Utilizing several modes of medication administration in conjunction with regional anesthetic improves pain relief and reduces the negative effects caused by opioids [12–16].

It is widely acknowledged that shifting focus from excruciating stimuli to alternative stimuli reduces the perception of pain [17]. The effectiveness of intentional distraction in reducing pain has been observed in research about fibromyalgia, chronic cervical pain, and wound-dressing adjustments [18]. Engaging patients in interactive VR may effectively divert their attention from unpleasant stimuli and reduce their subjective experience of pain [19]. Thus, VR may efficiently exploit the limited attention capacity and alleviate patients’ subjective perception of pain by diverting their concentration [20].

Clinical studies have demonstrated that VR therapy can effectively alleviate acute and chronic pain in patients [21–26]. In a meta-analysis conducted by Ding et al., it was shown that VR has the potential to alleviate postoperative pain in both minor and major surgeries. The research, which included 8 randomized controlled studies, showed a substantial decrease in postoperative pain among patients who received VR during both the intraoperative and postoperative periods [27].

VR may effectively manage pain not only by diverting attention but also by using cognitive-behavioral intervention methods [19, 28]. Game-like VR programs may enhance a patient’s motivation to stick to therapy since motivation plays a crucial role in their commitment to treatment. VR can provide a realistic experience for patients, making them feel as if they are there and actively engaging with their surroundings. This immersive technology enhances the sense of control and self-assurance [29]. Research has shown that VR therapy may improve functional recovery by offering patients a dynamic and captivating environment. Virtual environments replicate real-world tasks and difficulties, enabling patients to engage in deliberate practice and enhance their motor abilities inside a secure and regulated environment. Virtual environments replicate real-life activities and obstacles, enabling patients to participate in secure practice and enhance their motor abilities [30].

VR systems, while having a fundamental structure, exhibit variations in hardware and software requirements due to the diverse nature of their application domains. Scholars also emphasize different research usages [31]. For instance, VR simulators designed for educational purposes focus on network resources and 3D environments. Those intended for surgical training prioritize user interaction with virtual anatomical structures and equipment. Meanwhile, VR simulators developed to treat psychological disorders emphasize feedback and emotion regulation [32, 33]. While VR simulations designed for postoperative management prioritize physical therapy and rehabilitation, they often omit explicit training in pain control [34, 35]. Non-pharmaceutical pain management is a critical component of postoperative recovery for patients, yet the extant research on the effectiveness of VR software in pain mitigation is notably scarce. In response to this gap, our team has developed postoperative adjuvant analgesic software integrated with VR technology, to conduct a clinical trial to evaluate its effectiveness and safety in the context of postoperative pain management.

Postoperative adjuvant analgesic software

The postoperative adjuvant analgesic software utilized in our study has been developed by Guang Dong Liang Zi Health Consulting Co., Ltd. This innovative software is specifically designed to address postoperative pain management. It integrates an understanding of pain generation mechanisms with the theoretical principles of cognitive-behavioral therapy to enhance pain alleviation. By employing VR technology, the software effectively alters patients’ negative perceptions of pain. Through immersive and interactive training modules, patients are equipped with skills that promote physical relaxation and enable them to divert their attention from pain stimuli. Furthermore, the software seeks to engage the analgesic regulatory system by addressing the negative emotional experiences associated with pain, fostering an overall environment conducive to pain relief.

The software contains three training modules. The pain cognitive therapy training module primarily utilizes a high-tech instructional scene displayed on a video screen, complemented by an electronic sound background utilizing micro-current and voice guidance. Its objective is to empower patients with accurate pain comprehension and proficiency in pain control methods. Furthermore, it aims to support medical professionals and nursing staff in their efforts to educate postoperative patients about pain cognitively during the pain management process. Instruct patients that their negative perception of pain can be altered to alleviate it; this will decrease their dread and anxiety of pain and boost their confidence in their ability to recover. Pain behavioral therapy training module: In light of the patients’ erroneous perception of pain identified in the preceding pain cognitive therapy training module, this module empowers patients to master the fundamentals and strategies of pain relief via cognitive-behavioral therapy, alter their initial maladaptive behaviors, disrupt the detrimental cycle of “pain-negative emotion-increased pain,” and establish a positive self-perception. The patient will be automatically directed to the necessary pain behavioral therapy training materials by the software, in accordance with the treatment cycle and learning content in the pain cognitive therapy training module. Immersive interactive training module: The emotions most likely to be triggered by acute pain after surgery are fear and anxiety. The module offers patients a secure virtual environment in which they can engage in interactive experiences that bring them delight. The product’s interactive scene is designed to resemble a deep-sea environment, complete with the sound of ocean waves and the deep blue sea floor, in order to induce relaxation and alleviate anxiety in patients. Interactive training accommodates the postoperative mobility of patients by requiring only a gradual, simple head movement to complete the interaction without physical assistance; this eliminates the pulling pain that can be caused by large movements.

The postoperative adjuvant analgesic software leverages VR technology to diminish pain-related cognitive and emotional processing by integrating mechanisms of pain generation with cognitive-behavioral therapy. This innovative product employs cognitive-behavioral techniques alongside immersive interactive training to transform patients’ negative perceptions of pain. Through this approach, patients learn physical relaxation techniques that help them manage their pain more effectively. Additionally, the software addresses psychological factors that facilitate the body’s pain-relieving adjustment mechanisms, ultimately reducing the adverse emotional states associated with pain.

Methods

This study is a prospective, multicenter, open-label, randomized, controlled, superiority trial design with two parallel groups. The experimental group utilizes the postoperative adjuvant analgesic software in addition to conventional postoperative medication analgesia, while the control group only receives conventional postoperative medication analgesia. Three centers will participate in this multicenter clinical trial, which are Guangdong Provincial People’s Hospital, Tianjin Medical University General Hospital, and Ruijin Hospital. The study protocol follows the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) instructions. The study protocol received ethical approval from the Ethics Committees of Guangdong Provincial People’s Hospital, Tianjin Medical University General Hospital, and Ruijin Hospital. The data will be collected from the three academic hospitals mentioned above. This study was retrospectively registered in the Chinese Clinical Trial Registry (ChiCTR2400087741).

Participant population and recruitment

During preoperative consultations, thoracic surgeons from the aforementioned hospitals will identify potential participants and supply them with detailed information about the study. Interested prospective participants will then reach out to the research team to inquire further about the study’s eligibility criteria, specific details, and the informed consent form. Upon mutual agreement, both the participant and a member of the research team will sign and date the informed consent form, signifying their understanding and agreement to the terms of participation. Participants are informed that they retain the right to withdraw from the study at any time, either through written notification or verbal communication (Fig. 1).

Fig. 1.

Fig. 1

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SPIRIT figure

Participant eligibility

Inclusion criteria

Participants must meet all the following criteria:

  1. Participants must be 18 years of age or older, with no restrictions on gender.

  2. Patients must have undergone thoracoscopic surgery within the thoracic surgery department within the last 24 h.

  3. Participants should have completed at least junior high school education, possess fluent Mandarin communication skills, and demonstrate knowledge of the Internet as well as the ability to read and write on mobile devices.

  4. Participants must have a NRS pain [36] score of 4 or higher at 24 h post-surgery.

  5. Patients must be capable of understanding the study’s objectives, must voluntarily participate, provide informed consent, and express their willingness to comply with the follow-up requirements as specified in the study protocol.

Exclusion criteria

Participants will be excluded if they meet any of the following criteria:

  1. A history of severe cognitive impairment.

  2. A history of epilepsy, dementia, migraine, or other neurological conditions that may preclude the use of postoperative analgesic adjuvant software or may have adverse effects.

  3. An inability to understand or express Mandarin.

  4. A history of visual abnormalities, severe hearing impairment, or motion sickness that precludes the use of VR devices.

  5. A history of ocular, facial, or cervical trauma that impedes the use of VR devices.

  6. A history of severe cardiac, hepatic, renal, hematologic, gastrointestinal, neurological disorders, or malnutrition.

  7. Patients who have previously experienced ineffective pain treatment using VR software.

  8. A history of severe alcohol abuse, prolonged high alcohol consumption, or symptoms of alcohol dependence.

  9. Having participated in any analgesic intervention study within the past week.

  10. Female participants who are pregnant or planning to become pregnant during the study.

  11. Participants or their immediate family members employed by digital health or pharmaceutical companies specializing in acute or chronic pain treatments.

  12. An inability to use electronic devices such as smartphones.

  13. Any additional conditions deemed unsuitable for intervention by the investigator.

Study discontinuation

Participants will be removed from the study if any of the following occur:

  1. Unwilling or incapable of continuing clinical study or lost to follow-up.

  2. Serious adverse events (SAEs) preventing the participants from completing the subsequent study, as determined by the investigator’s judgment.

  3. Other complications preventing the participants from completing the subsequent study.

  4. False enrollment for not meeting eligibility criteria.

  5. Serious protocol deviations, including using devices or analgesia beyond the prescribed limits, prevent clinical outcome evaluation.

  6. Poor compliance.

Furthermore, participants may disengage from the study at any given moment. Upon the participant’s withdrawal from the study, all further data collection ceases.

Objectives

The primary outcome measure will be the effectiveness of the postoperative adjuvant analgesic software treatment, as assessed by the reduction in NRS scores after the second intervention at 48 h postoperatively compared to pre-intervention baseline at 24 h postoperatively. The secondary outcome measure will pertain to the safety of the postoperative adjuvant analgesic software treatment. The safety will be evaluated based on the incidence rates of adverse events (AEs), serious adverse events (SAEs), device-related adverse events (DRAEs), and device-related serious adverse events (DRSAEs), which will serve as indicators of the treatment’s safety profile.

Sample size

Before initiating the main experiment, a feasibility verification study was conducted to assess the NRS pain scores in both the experimental and control groups. For the experimental group, the NRS pain scores were 4.37 at 24 h post-surgery prior to intervention, 3.4 at 24 h post-intervention, and 2.8 at 48 h post-intervention. The control group’s NRS pain scores at these respective time points were 4.27, 4.2, and 3.4. The reduction in NRS pain scores was calculated as 1.57 (with a standard deviation of 0.71) for the experimental group and 0.87 (with a standard deviation of 0.55) for the control group.

A superiority test was performed to compare the two groups. The margin of superiority was set at 0.35, the type I error rate was 0.05 (two-sided), and the desired test power was 90%. Both groups were equally sized, with an assumed standard deviation of 0.7 for both. Utilizing the sample size estimation formula for a superiority test comparing group means, it was determined that the study required 86 participants in each group, totaling 172 participants [37]. Accounting for a dropout rate of 20% due to sudden pain, excessive oral analgesic consumption, or withdrawal from the study as determined by the investigator, the sample size was adjusted to 215 participants to ensure the study’s primary objectives could be met [38].

Assignment of interventions: allocation and blinding

Following recruitment, participants will be randomly assigned to one of two study arms using a simple randomization method. After signing the informed consent form, each participant will be assigned a unique screening number. The randomization to the study arms will be revealed only after the entire screening process has been completed. To ensure allocation concealment and impartiality, physicians at participating centers will call a designated statistician at an independent institution who maintains the confidential randomization list and assigns treatment allocations. The random numbers are generated utilizing SPSS statistical software to ensure impartiality and scientific rigor. Participants will be evenly randomized into one of the two study arms with a 1:1 allocation ratio. The allocation will remain concealed until the group assignment is complete.

The randomization sequence is generated by an independent statistician using computer-generated random numbers, and group assignments are placed in sequentially numbered, opaque, sealed envelopes to ensure concealment. However, due to the absence of a VR-based intervention in the control group, it is not feasible to maintain blinding for both participants and investigators. Consequently, an open-label trial design is implemented, wherein all research study participants, clinical staff, and team members are aware of the group assignment to which each individual is allocated. Despite the lack of blinding, allocation concealment is rigorously maintained during enrollment to prevent selection bias.

Interventions: conventional postoperative analgesia

Both the experimental group and the control group will receive identical conventional postoperative analgesia. The protocol for conventional postoperative analgesia is as follows:

  1. Analgesic method: patient-controlled intravenous analgesia (PCIA) administered via a mechanical analgesic pump.

  2. Administration route: intravenous injection.

  3. Analgesic micropump working mode:

  4. Background dose: 2 mL/h.

  5. Patient-controlled dose: 0.5 mL, with a 15-min lockout period.

  6. Total capacity: 100 mL.

  7. Micropump drug dose: a mixture of 200 mg flurbiprofen axetil injection and 30 mg dezocine injection, along with 8 mg ondansetron hydrochloride injection or 8 mg tropisetron mesylate injection, diluted to a total volume of 100 mL with 0.9% sodium chloride injection.

  8. Micropump removal: the micropump will be removed 48 h post-surgery, and any remaining dose will be documented.

  9. Pain outbreak analgesia: 50 mg flurbiprofen axetil injection via intravenous injection.

Interventions: postoperative adjuvant analgesic software treatment

After obtaining informed consent, participants’ NRS pain scores will be assessed 24 h post-surgery. Patients with an NRS pain score of less than 4 at this time point will be excluded from the study. Following enrollment, participants will be randomly assigned to either the experimental group or the control group using a simple randomization method.

The experimental group will receive postoperative adjuvant analgesic software treatment 24 and 48 h post-surgery. An NRS pain score evaluation will be conducted within 30 min after each intervention session. The control group, which will receive standard postoperative medication analgesia and have its pain scores recorded at the corresponding time points, will not undergo the aforementioned software intervention. All participants will receive the same standard postoperative medication analgesia as per the study protocol.

Participants assigned to the experimental group will undergo postoperative adjuvant analgesic software treatment in a seated or reclined position on their ward beds. A research nurse will assist participants with the setup of the VR equipment and guide them through the software navigation. The research nurses will undergo comprehensive training prior to the start of the experiment to ensure standardized support.

Upon initiating the software, participants will be presented with a 4-min audio-visual tutorial, which they have the option to bypass. The intervention includes a progressive relaxation training program, attention-shifting games, and a breathing training program, all conducted within an immersive VR environment. The intervention is expected to last approximately 10 to 15 min, during which participants will be in a tranquil and undisturbed setting. Following the intervention, participants will self-report their NRS pain score on a questionnaire.

The control group, in contrast, will receive only standard postoperative medication analgesia without any additional interventions. They will complete the NRS pain score assessments and vital sign recordings at the same time points as the experimental group.

Statistical analysis

Researchers will instruct participants on how to accurately rate their NRS pain scores, with assessments conducted while participants are at rest. The experimental group will undergo three NRS pain assessments: the first within 30 min at 24 h postoperatively followed by the first intervention; the second within 30 min after the first intervention; and the third within 30 min after the second intervention at 48 h postoperatively. The control group will also undergo three NRS pain assessments: the first within 30 min at 24 h postoperatively, the second within 30 min after the first assessment, and the third within 30 min at 48 h postoperatively. The primary outcome measure will be the reduction in NRS pain scores between the first and third assessments in both the experimental and control groups. Descriptive and comparative analyses of NRS pain scores between the two groups will be performed.

The primary analysis will follow the intention-to-treat (ITT) principle by including all randomized participants in their originally assigned groups, whether they received the VR-based adjuvant analgesic software or conventional postoperative analgesia. Missing data from dropouts or missed assessments will be analyzed as-is without imputation, leveraging the study’s structured follow-up schedule at 24 and 48 h postoperatively. To confirm the robustness of findings, a secondary per-protocol (PP) analysis will exclude participants who violated key study protocols such as non-adherence to interventions or eligibility criteria. Should substantial missing data emerge, the study may employ supplementary sensitivity analyses like multiple imputation to assess potential biases. The statistical plan prioritizes the ITT population as the primary analysis set while using PP analysis for validation.

For measurement data that follow a normal distribution, results will be presented as the mean ± standard deviation (SD). Data that do not follow a normal distribution will be expressed as the median (M) with the interquartile range (P25, P75). The primary analysis will employ an unadjusted ANOVA to compare the mean reduction in NRS pain scores between the experimental and control groups, with a test for equivalence of variances conducted to validate homogeneity assumptions. Clustering by multicenter sites will not be explicitly adjusted for in the primary analysis, as the study design emphasizes simple randomization with equal allocation across centers, and the sample size is calculated to ensure sufficient power for group comparisons without hierarchical modeling. However, sensitivity analyses may explore potential center effects if significant variability is observed post hoc.

Adverse events

In this study, potential AEs encompass nausea, active vomiting, dizziness, vertigo, seizures, urinary retention, and respiratory depression. Comprehensive documentation of these events will include the following parameters: initiation and cessation of AEs, frequency, severity, recurrence, interventions undertaken, correlation assessment with the study intervention, identification of the drug or device involved, and classification as a SAE. Should a participant experience a SAE that impedes their ability to continue in the study, the investigator retains the prerogative to discontinuation of the clinical trial for that participant.

Discussion

Compared with open thoracotomy, video-assisted thoracoscopic surgery (VATS) is associated with cosmesis, a reduced duration of stay, and a comparatively reduced total expense [39]. It can decrease operating stress by minimizing surgical trauma. However, immediate postoperative pain, ranging from moderate to severe, is still associated with VATS, specifically VATS lobectomy [40]. In fact, the etiology of pain following VATS is similar to that after open thoracotomy, mostly caused by the incision trauma, chest tube placement, and the shoulder pain syndrome [41]. The guidelines strongly recommend using non-pharmacological treatments combined with pharmaceutical therapy to manage postoperative pain, which has been a key focus in recent years [42]. Research on the effectiveness of VR software in postoperative pain control following VATS is extremely limited, despite the potential of VR interventions as a non-pharmacological tool for reducing pain after surgery.

The postoperative adjuvant analgesic software utilized in our study has been developed by Guang Dong Liang Zi Health Consulting Co., Ltd. and is grounded in the Gate Control Theory of Pain, proposed by Melzack and Wall in 1965 [43]. This theory has significantly advanced our understanding of pain perception, suggesting that pain is not merely a linear response to nociceptive stimulation but is subject to modulation by various neural interactions [44]. Specifically, it involves A-delta fibers, which rapidly conduct acute pain signals, and C fibers, which transmit chronic pain signals more slowly, both converging on the dorsal horn of the spinal cord where a “gate” mechanism is believed to modulate the transmission of pain signals [45].

Our VR intervention is designed to engage the brain’s attentional systems and alter pain perception by activating these neural pathways within an immersive environment. Coupled with CBT, our approach aims not only to metaphorically “close” the neurological gate to pain signals but also to augment the patient’s capacity to manage and mitigate the psychological dimensions of pain [46, 47]. This integrative strategy addresses both the physiological and psychological components of pain, providing a comprehensive solution to pain management [48, 49].

This study protocol has several strengths, including its multicenter randomized controlled design, standardized pain assessment using the NRS, and adherence to rigorous methodological standards such as allocation concealment and intention-to-treat analysis. The integration of VR-based cognitive-behavioral therapy into postoperative pain management is innovative, addressing a critical gap in non-pharmacological interventions.

However, the protocol is exposed to several notable limitations, primarily due to its open-label design and reliance on participant-reported outcomes. The lack of blinding introduces a high risk of detection and assessment bias, as patients and investigators are aware of group allocation, potentially influencing pain reporting and intervention administration. The subjective nature of the NRS, while validated, makes it susceptible to placebo effects, particularly since VR interventions may heighten patient expectations of pain relief. Without objective physiological measures (e.g., biomarkers or autonomic responses), the results may overestimate the intervention’s efficacy. Additionally, the absence of a sham VR control group limits the ability to isolate the specific effects of VR from general distraction or attention-shifting mechanisms. The exclusion of patients with severe comorbidities or cognitive impairments may also restrict the generalizability of findings to broader clinical populations.

Despite these limitations, this protocol provides an elaborate account of a randomized controlled trial that aims to assess the effectiveness and safety of VR-based postoperative adjuvant analgesic software in mitigating pain among patients undergoing VATS surgery. Based on our current understanding, this research represents an initial attempt to evaluate the effectiveness of specialized postoperative adjuvant analgesic software utilizing VR equipment in alleviating postoperative pain. The findings of this study will contribute to the advancement of a novel approach to administering evidence-based treatments.

Trial status

The pilot study was conducted between November 2022 and February 2023. The patient recruitment started in March 2023 and ended in March 2025 as expected. The present version of the protocol is 1.1 (March 2023).

Acknowledgements

Not applicable.

Abbreviations

AEs

Adverse events

DRAEs

Device-related adverse events

DRSAEs

Device-related serious adverse events

NRS

Numerical rating scale

VR

Virtual reality

PCIA

Patient-controlled intravenous analgesia

SAEs

Serious adverse events

Authors' contributions

Conceptualization (SX, WZ, HL); writing—original draft (XF, WG); writing—review and editing (XF, WG, BJ, TL, YL). All the authors have reviewed the present version of the manuscript and approved it for submission.

Funding

This study was supported by the National Natural Science Foundation of China (82072557, 82372855), National Key Research and Development Program of China (2021YFC2500900), Interdisciplinary Program of Shanghai Jiao Tong University (YG2023ZD04), and Novel Interdisciplinary Research Project from Shanghai Municipal Health Commission (2022JC023)

Data availability

The findings of this study will be published in peer-reviewed international journals and presented at prestigious international conferences. We will provide patients with access to all study results upon request. Following publication in a peer-reviewed journal, the materials utilized in the study will be made available upon request. The datasets associated with this study can be obtained from the corresponding author upon reasonable request.

Ethics approval and consent to participate

All processes strictly adhered to the guidelines of the Ethics Committee and were in accordance with the principles of the Declaration of Helsinki. This study was approved by the Ethics Committee of Guangdong Provincial People’s Hospital (QX2022-041), Shanghai Jiao Tong University School of Medicine, Ruijin Hospital Ethics Committee (2023-23), and Ethics Committee of Tianjin Medical University General Hospital (IRB2023-014–01). All participants will be required to provide written, informed consent before participating the study.

Consent for publication

Not applicable.

Competing interests

Yi Lu was employed by company Guang Dong Liang Zi Health Consulting Co., Ltd. Other authors declare that they have no conflict of interest.

Footnotes

Publisher's Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Xijia Feng, Wei Guo, Benyuan Jiang, and Tong Li contributed equally to this study and are co-first authors.

Contributor Information

Song Xu, Email: xusong198@hotmail.com.

Wenzhao Zhong, Email: syzhongwenzhao@scut.edu.cn.

Hecheng Li, Email: lihecheng2000@hotmail.com.

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Associated Data

This section collects any data citations, data availability statements, or supplementary materials included in this article.

Data Availability Statement

The findings of this study will be published in peer-reviewed international journals and presented at prestigious international conferences. We will provide patients with access to all study results upon request. Following publication in a peer-reviewed journal, the materials utilized in the study will be made available upon request. The datasets associated with this study can be obtained from the corresponding author upon reasonable request.

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