Status:
RECRUITING
Effectiveness and Safety of Adjuvant Software Based on Virtual Reality for Post-thoracoscopic Surgery Pain
Lead Sponsor:
Guangdong Provincial People's Hospital
Collaborating Sponsors:
Guang Dong Liang Zi Health Consulting Co., Ltd, Guang Dong, China.
Tianjin Medical University General Hospital
Conditions:
Acute Postoperative Pain
Video-assisted Thoracic Surgery
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 surg...
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 tes...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Patients with severe cognitive impairment.
- 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.
- Patients who are unable to understand or speak Mandarin.
- Patients who have visual abnormalities, severe hearing impairment, or motion sickness, etc., and are unable to view VR.
- Patients with trauma to the eyes, face, or neck that prevents the comfortable use of the VR device.
- Patients with severe heart, liver, kidney, hematologic, digestive, nervous system diseases and malnutrition.
- Patients who have previously used virtual reality software for pain that has not responded to treatment.
- Patients with a history of severe alcohol abuse, long-term heavy drinking, and symptoms of alcohol dependence.
- Patients who have participated in any analgesic interventional study within the past 1 week.
- Females who are pregnant or plan to become pregnant during the study.
- The patient or their immediate family member works for a digital health or pharmaceutical company for acute or chronic pain treatment.
- Patients who are unable to use electronic devices such as smartphones.
- Other conditions that the investigator considers inappropriate for participation in a clinical trial.
Key Trial Info
Start Date :
April 22 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 24 2025
Estimated Enrollment :
215 Patients enrolled
Trial Details
Trial ID
NCT06574451
Start Date
April 22 2023
End Date
April 24 2025
Last Update
August 28 2024
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences
Guangzhou, Guangdong, China, 510080
2
Maoming People's Hospital
Maoming, Guangdong, China
3
Ruijing Hospital, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, China
4
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China