Clinical trial NCT06574451: Effectiveness and Safety of Adjuvant Software Based on Virtual Reality for Post-thoracoscopic Surgery Pain
Official title: Effectiveness and Safety of Adjuvant Software Based on Virtual Reality for Post-thoracoscopic Surgery Pain (VR-TSP)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Postoperative Pain
Video-assisted Thoracic Surgery
Virtual Reality
Keywords: Acute Postoperative Pain
VATS
VR
Lead sponsor: Guangdong Provincial People's Hospital
Sponsor class: OTHER
Collaborators: name: Guang Dong Liang Zi Health Consulting Co., Ltd, Guang Dong, China.
name: Tianjin Medical University General Hospital
name: Ruijin Hospital
name: Maoming People's Hospital
First posted: 2024-08-28
Enrollment: 215
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 surgery pain.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Numeric Rating Scale (NRS)
timeFrame: The NRS evaluation is within 30 minutes of 24 and 48 hours after surgery.
Secondary outcomes:
measure: Incidence of adverse events
timeFrame: Assessment of adverse events is completed within 2 days postoperatively
measure: Incidence of serious adverse events
timeFrame: Assessment of serious adverse events is completed within 2 days postoperatively
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences
state: Guangdong
city: Maoming
country: China
facility: Maoming People's Hospital
state: Guangdong
city: Shanghai
country: China
facility: Ruijing Hospital, Shanghai Jiao Tong University
state: Shanghai
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
state: Tianjin
Study officials:
affiliation: Guangdong Provincial People's Hospital
name: Wen-Zhao Zhong
role: PRINCIPAL_INVESTIGATOR
References: