Effect of Virtual Reality on Patients With Acute Pain After Thoracoscopic Surgery

NCT05926817 | Completed

• 1 other identifier: IRB2021-YX-173-01
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

Immersive virtual reality (VR) as a non-pharmaceutical technology may deliver effective behavioral therapies for postsurgical patients with acute pain. To determine the analgesic effects of VR on patients after thoracoscopic surgery. The investigators conducted a randomized clinical trial to determine the postoperative effect of VR on pain relief in patients undergoing thoracoscopic surgery.

Conditions

Virtual Reality; Acute Postoperative Pain; Thoracic Surgery, Video-Assisted

Outcome Measures

Primary Outcomes (1)

• Change in Pain intensity evaluating by the numerical rating scale (NRS)

  The primary outcome was the change in pain intensity following the QTC-VR and Placebo-VR intervention.

  Evaluating pain intensity among postoperative patients 10 minutes prior to and 30 minutes following the intervention

Secondary Outcomes (6)

• Pain-related interference on patients' mood by the brief pain inventory (BPI)

  The patients' pain interference was evaluated within 30 minutes of the intervention.

• Pain-related interference on patients' sleep by the brief pain inventory (BPI)

  The patients' pain interference was evaluated within 30 minutes of the intervention.

• Pain-related interference on patients' daily life by the brief pain inventory (BPI)

  The patients' pain interference was evaluated within 30 minutes of the intervention.

• Pain-related interference on patients' interest in life by the brief pain inventory (BPI)

  The patients' pain interference was evaluated within 30 minutes of the intervention.

• Pain-related interference on patients' walking ability by the brief pain inventory (BPI)

  The patients' pain interference was evaluated within 30 minutes of the intervention.

Study Arms (3)

Control group

NO INTERVENTION

Postoperative standard analgesia was administered to patients in the control group.

Placebo-VR group

PLACEBO COMPARATOR

Patients in the Placebo-VR group watched a 10-minute relaxation-based 2D film through VR headsets along with receiving conventional analgesia.

Device: Placebo-VR headsets

QTC-VR group

EXPERIMENTAL

Patients in the QTC-VR group engaged in 10-minute interactive pain relief 3D VR programs while wearing VR headsets along with receiving conventional analgesia.

Device: QTC-VR headsets

Interventions

Placebo-VR headsets DEVICE

Patients in the Placebo-VR group watched a 10-minute relaxation-based 2D film through VR headsets along with receiving conventional analgesia.

Placebo-VR group

QTC-VR headsets DEVICE

Patients in the QTC-VR group engaged in 10-minute interactive pain relief 3D VR programs while wearing VR headsets along with receiving conventional analgesia.

QTC-VR group

Eligibility Criteria

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

You may qualify if:

• The patient's age is ≥ 18, regardless of gender.
• Within one day after thoracoscopic surgery.
• The NRS of postoperative pain is ≥ four.
• Having specific internet knowledge and mobile phone reading and writing abilities.
• Patients voluntarily sign the informed consent form and are willing to complete the follow-up according to the trial protocol.

You may not qualify if:

• Patients have severe cognitive disorders.
• Patients with previous diagnoses of epilepsy, dementia, migraine, or other neurological diseases may have difficulty using the VR headset.
• Patients are sensitive to light stimulation.
• Patients are without stereopsis or with severe hearing impairment.
• Patients with trauma to the eyes, face, or neck are not comfortable using VR headsets.
• Patients have severe heart, liver, kidney, blood, digestive, and nervous diseases.
• Patients previously used the VR headset but found it ineffective.
• Patients have a history of severe alcoholism, long-term heavy drinking, and symptoms of alcohol dependence.
• Patients have participated in any analgesic intervention study in the past week.
• Women have pregnancy plans during the follow-up period of the study.
• Patients and their families work in digital health or pharmaceutical companies for acute or chronic pain management.
• Patients cannot use electronic devices such as smartphones.

Sponsors & Collaborators

• Tianjin Medical University: lead

Study Sites (1)

Tianjin Medical University General Hospital

Tianjin, 300052, China

Location

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

• Song Xu

  Tianjin Medical University General Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: June 14, 2023
• First Posted: July 3, 2023
• Study Start: October 19, 2021
• Primary Completion: March 6, 2023
• Study Completion: March 7, 2023
• Last Updated: February 5, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)