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

NCT ID: NCT05926817

Last Updated: 2024-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-19
• Study Completion Date: 2023-03-07

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.

Detailed Description

Immersive virtual reality (VR) as a non-pharmaceutical technology may deliver effective behavioral therapies for postsurgical patients with acute pain. Patients in the QTC-VR group had to participate in 15-minute interactive games wearing 3D-VR headsets. QTC-VR intervention had functions for breath-relaxation and attention-concentration training. It instructed the patients to breathe deeply with the marine animal's swimming relaxation rhythm and to constantly switch the vision field by rotating their heads and necks to catch animals. Therefore, the investigators conducted a randomized clinical trial to determine the postoperative effect of QTC-VR on pain relief in patients undergoing thoracoscopic surgery.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Control group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Placebo-VR group

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

Group Type: PLACEBO_COMPARATOR

Placebo-VR headsets

Intervention Type: DEVICE

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

QTC-VR group

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.

Group Type: EXPERIMENTAL

QTC-VR headsets

Intervention Type: 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.

Interventions

Placebo-VR headsets

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

Intervention Type: DEVICE

QTC-VR headsets

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. The patient's age is ≥ 18, regardless of gender.

2. Within one day after thoracoscopic surgery.

3. The NRS of postoperative pain is ≥ four.

4. Having specific internet knowledge and mobile phone reading and writing abilities.

5. Patients voluntarily sign the informed consent form and are willing to complete the follow-up according to the trial protocol.

Exclusion Criteria

1. Patients have severe cognitive disorders.

2. Patients with previous diagnoses of epilepsy, dementia, migraine, or other neurological diseases may have difficulty using the VR headset.

3. Patients are sensitive to light stimulation.

4. Patients are without stereopsis or with severe hearing impairment.

5. Patients with trauma to the eyes, face, or neck are not comfortable using VR headsets.

6. Patients have severe heart, liver, kidney, blood, digestive, and nervous diseases.

7. Patients previously used the VR headset but found it ineffective.

8. Patients have a history of severe alcoholism, long-term heavy drinking, and symptoms of alcohol dependence.

9. Patients have participated in any analgesic intervention study in the past week.

10. Women have pregnancy plans during the follow-up period of the study.

11. Patients and their families work in digital health or pharmaceutical companies for acute or chronic pain management.

12. Patients cannot use electronic devices such as smartphones.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tianjin Medical University

OTHER

Sponsor Role: lead

Responsible Party

Weibo Cao

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Song Xu

Role: STUDY_DIRECTOR

Tianjin Medical University General Hospital

Locations

Tianjin Medical University General Hospital

Tianjin, , China

Countries

China

Other Identifiers

IRB2021-YX-173-01

Identifier Type: -

Identifier Source: org_study_id