Effectiveness and Safety of Adjuvant Software Based on Virtual Reality for Post-thoracoscopic Surgery Pain (VR-TSP)
Status: Recruiting
Location: See all (4) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 1.Age greater than or equal to 18 years.
⁃ Patients within 1 day after thoracoscopic surgery.
⁃ Junior high school degree or above, Mandarin communication is unimpeded, with certain Internet knowledge and mobile phone reading and writing skills.
⁃ The score of the numeric grading scale (NRS) at 24 hours postoperatively ≥ 4 points.
⁃ 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.
Locations
Other Locations
China
Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences
RECRUITING
Guangzhou
Maoming People's Hospital
RECRUITING
Maoming
Ruijing Hospital, Shanghai Jiao Tong University
RECRUITING
Shanghai
Tianjin Medical University General Hospital
RECRUITING
Tianjin
Contact Information
Primary
Wen-Zhao Zhong
syzhongwenzhao@scut.edu.cn
+86-13609777314
Backup
Ben-Yuan Jiang
jiangben1000@126.com
+86-18613025014
Time Frame
Start Date: 2023-04-22
Estimated Completion Date: 2025-04-24
Participants
Target number of participants: 215
Treatments
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.
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.
Related Therapeutic Areas
Sponsors
Leads: 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.