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

August 25, 2024 updated by: Guangdong Provincial People's Hospital

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
215

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • Recruiting
        • Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences
        • Contact:
        • Principal Investigator:
          • Wen-zhao Zhong, PhD
        • Contact:
        • Sub-Investigator:
          • Ben-Yuan Jiang, PhD
        • Sub-Investigator:
          • Yi-Fan Qi, PhD
        • Sub-Investigator:
          • Chen Huang
        • Sub-Investigator:
          • You Wu
        • Sub-Investigator:
          • Yi-Duo Lin
      • Maoming, Guangdong, China
        • Recruiting
        • Maoming People's Hospital
        • Contact:
          • Zhi-Qiang Luo
        • Contact:
          • Xiao-Yang Su
        • Principal Investigator:
          • Zhi-Qiang Luo
        • Sub-Investigator:
          • Xiao-Yang Su
        • Sub-Investigator:
          • Jian Huang
    • Shanghai
      • Shanghai, Shanghai, China
        • Recruiting
        • Ruijing Hospital, Shanghai Jiao Tong University
        • Contact:
          • He-Cheng Li, PhD
        • Contact:
          • Guo Wei
        • Principal Investigator:
          • He-Cheng Li
        • Sub-Investigator:
          • Wei Guo
        • Sub-Investigator:
          • Xi-Jia Feng
    • Tianjin
      • Tianjin, Tianjin, China
        • Recruiting
        • Tianjin Medical University General Hospital
        • Contact:
          • Song Xu, PhD
        • Contact:
          • Fan Ren, PhD
        • Principal Investigator:
          • Song Xu
        • Sub-Investigator:
          • Fan Ren
        • Sub-Investigator:
          • Tong Li
        • Sub-Investigator:
          • Wei-Bo Cao

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Device: 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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Numeric Rating Scale (NRS)
Time Frame: The NRS evaluation is within 30 minutes of 24 and 48 hours after surgery.
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Incidence of adverse events
Time Frame: Assessment of adverse events is completed within 2 days postoperatively
Any unfavorable medical occurrence during the course of the study, whether device-related or not, is an adverse event.
Assessment of adverse events is completed within 2 days postoperatively
Incidence of serious adverse events
Time Frame: Assessment of serious adverse events is completed within 2 days postoperatively
If an event occurs during the clinical study that results in death or serious deterioration of health status, it is judged to be a serious adverse event
Assessment of serious adverse events is completed within 2 days postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Guangdong Provincial People's Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ruijin Hospital
Tianjin Medical University General Hospital
Maoming People's Hospital
Guang Dong Liang Zi Health Consulting Co., Ltd, Guang Dong, China.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Wen-Zhao Zhong, Guangdong Provincial People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 22, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 24, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 24, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 25, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 25, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 28, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 28, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 25, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • VR-TSP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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