Effectiveness and Safety of Adjuvant Software Based on Virtual Reality for Post-thoracoscopic Surgery Pain
NCT ID: NCT06574451
Last Updated: 2024-08-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
215 participants
INTERVENTIONAL
2023-04-22
2025-04-24
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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.
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.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Guang Dong Liang Zi Health Consulting Co., Ltd, Guang Dong, China.
UNKNOWN
Tianjin Medical University General Hospital
OTHER
Ruijin Hospital
OTHER
Maoming People's Hospital
OTHER
Guangdong Provincial People's Hospital
OTHER
Responsible Party
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Principal Investigators
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Wen-Zhao Zhong
Role: PRINCIPAL_INVESTIGATOR
Guangdong Provincial People's Hospital
Locations
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Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences
Guangzhou, Guangdong, China
Maoming People's Hospital
Maoming, Guangdong, China
Ruijing Hospital, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Zhi-Qiang Luo
Role: primary
Xiao-Yang Su
Role: backup
He-Cheng Li, PhD
Role: primary
Guo Wei
Role: backup
Song Xu, PhD
Role: primary
Fan Ren, PhD
Role: backup
Other Identifiers
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VR-TSP
Identifier Type: -
Identifier Source: org_study_id
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