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

NCT06574451 | Recruiting

• 1 other identifier: VR-TSP
• Study Type: interventional
• Target: 215
• Locations: 1 country
• Sites: 4

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.

Conditions

Acute Postoperative Pain; Video-assisted Thoracic Surgery; Virtual Reality

Keywords

Acute Postoperative Pain; VATS; VR

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Incidence of adverse events

  Assessment of adverse events is completed within 2 days postoperatively

• Incidence of serious adverse events

  Assessment of serious adverse events is completed within 2 days postoperatively

Study Arms (2)

VR-assisted postoperative analgesia group

EXPERIMENTAL

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

Non-VR-assisted analgesia group

NO INTERVENTION

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.

Interventions

VR-assisted postoperative analgesia DEVICE

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.

VR-assisted postoperative analgesia group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guangdong Provincial People's Hospital: lead
• Guang Dong Liang Zi Health Consulting Co., Ltd, Guang Dong, China.: collaborator
• Tianjin Medical University General Hospital: collaborator
• Ruijin Hospital: collaborator
• Maoming People's Hospital: collaborator

Study Sites (4)

Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences

Guangzhou, Guangdong, 510080, China

RECRUITING

Maoming People's Hospital

Maoming, Guangdong, China

RECRUITING

Ruijing Hospital, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, China

RECRUITING

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, China

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Wen-Zhao Zhong

  Guangdong Provincial People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wen-Zhao Zhong

CONTACT

+86-13609777314; syzhongwenzhao@scut.edu.cn

Ben-Yuan Jiang

CONTACT

+86-18613025014; jiangben1000@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2024
• First Posted: August 28, 2024
• Study Start: April 22, 2023
• Primary Completion: April 24, 2025
• Study Completion: April 24, 2025
• Last Updated: August 28, 2024

Record last verified: 2024-04

Locations

CN (4)