RecruitingNot ApplicableNCT06574451

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

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


Sponsor

Guangdong Provincial People's Hospital

Enrollment

215 participants

Start Date

Apr 22, 2023

Study Type

INTERVENTIONAL

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria5

  • 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 Criteria13

  • 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.

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Interventions

DEVICEVR-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.


Locations(4)

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

View Full Details on ClinicalTrials.gov

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NCT06574451