Effectiveness and Safety of Adjuvant Software Based on Virtual Reality for Post-thoracoscopic Surgery Pain (VR-TSP)

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Postoperative Pain; Virtual Reality; Video-assisted Thoracic Surgery
• Intervention / Treatment: Device: VR-assisted postoperative analgesia

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 Type: Interventional
• Enrollment (Estimated): 215
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wen-Zhao Zhong; Phone Number: +86-13609777314; Email: syzhongwenzhao@scut.edu.cn
• Study Contact Backup: Name: Ben-Yuan Jiang; Phone Number: +86-18613025014; Email: jiangben1000@126.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • Recruiting
      • Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences
      • Contact: Wen-zhao Zhong, PhD; Phone Number: 51221 +86 20 83827812; Email: syzhongwenzhao@scut.edu.cn
      • Principal Investigator: Wen-zhao Zhong, PhD
      • Contact: Ben-Yuan Jiang, PhD; Phone Number: +8618613025014; Email: jiangben1000@126.com
      • Sub-Investigator: Ben-Yuan Jiang, PhD
      • Sub-Investigator: Yi-Fan Qi, PhD
      • Sub-Investigator: Chen Huang
      • Sub-Investigator: You Wu
      • Sub-Investigator: Yi-Duo Lin
    • Maoming, Guangdong, China
      • Recruiting
      • Maoming People's Hospital
      • Contact: Zhi-Qiang Luo
      • Contact: Xiao-Yang Su
      • Principal Investigator: Zhi-Qiang Luo
      • Sub-Investigator: Xiao-Yang Su
      • Sub-Investigator: Jian Huang
  • Shanghai
    • Shanghai, Shanghai, China
      • Recruiting
      • Ruijing Hospital, Shanghai Jiao Tong University
      • Contact: He-Cheng Li, PhD
      • Contact: Guo Wei
      • Principal Investigator: He-Cheng Li
      • Sub-Investigator: Wei Guo
      • Sub-Investigator: Xi-Jia Feng
  • Tianjin
    • Tianjin, Tianjin, China
      • Recruiting
      • Tianjin Medical University General Hospital
      • Contact: Song Xu, PhD
      • Contact: Fan Ren, PhD
      • Principal Investigator: Song Xu
      • Sub-Investigator: Fan Ren
      • Sub-Investigator: Tong Li
      • Sub-Investigator: Wei-Bo Cao

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

  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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VR-assisted postoperative analgesia group; 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.	Device: VR-assisted postoperative analgesia; 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.
No Intervention: Non-VR-assisted analgesia group; 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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	The NRS evaluation is within 30 minutes of 24 and 48 hours after surgery.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of adverse events	Any unfavorable medical occurrence during the course of the study, whether device-related or not, is an adverse event.	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	Assessment of serious adverse events is completed within 2 days postoperatively

Collaborators and Investigators

• Sponsor: Guangdong Provincial People's Hospital
• Collaborators: Ruijin Hospital; Tianjin Medical University General Hospital; Maoming People's Hospital; Guang Dong Liang Zi Health Consulting Co., Ltd, Guang Dong, China.
• Investigators: Principal Investigator: Wen-Zhao Zhong, Guangdong Provincial People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 22, 2023
• Primary Completion (Estimated): April 24, 2025
• Study Completion (Estimated): April 24, 2025

Study Registration Dates

• First Submitted: August 25, 2024
• First Submitted That Met QC Criteria: August 25, 2024
• First Posted (Actual): August 28, 2024

Study Record Updates

• Last Update Posted (Actual): August 28, 2024
• Last Update Submitted That Met QC Criteria: August 25, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: VATS; VR; Acute Postoperative Pain
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: VR-TSP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No