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

Not Applicable

Completed

• Conditions: Virtual Reality; Thoracic Surgery, Video-Assisted; Acute Postoperative Pain
• Interventions: Device: Placebo-VR headsets; Device: QTC-VR headsets

• Registration Number: NCT05926817
• Lead Sponsor: Tianjin Medical University

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.

Study Timeline

• Study Start: 2021-10-19
• Primary Completion: 2023-03-06
• Study Completion: 2023-03-07
• Study First Submitted: 2023-06-14
• Study First Submitted QC: 2023-06-23
• Study First Posted: 2023-07-03
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-02
• Last Update Posted: 2024-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo-VR group	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.
QTC-VR group	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.

Primary Outcome Measures

Name	Time	Method
Change in Pain intensity evaluating by the numerical rating scale (NRS)	Evaluating pain intensity among postoperative patients 10 minutes prior to and 30 minutes following the intervention	The primary outcome was the change in pain intensity following the QTC-VR and Placebo-VR intervention.

Secondary Outcome Measures

Name	Time	Method
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.	Secondary outcomes included the pain interference on their walking ability.
Patient satisfaction regarding the VR by the satisfaction evaluation form	We assessed patient satisfaction with VR after the end of the third day of the VR intervention.	Secondary outcomes included patient satisfaction regarding the VR intervention.
Pain-related interference on patients' mood by the brief pain inventory (BPI)	The patients' pain interference was evaluated within 30 minutes of the intervention.	Secondary outcomes included the pain interference on their mood.
Pain-related interference on patients' sleep by the brief pain inventory (BPI)	The patients' pain interference was evaluated within 30 minutes of the intervention.	Secondary outcomes included the pain interference on their sleep.
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.	Secondary outcomes included the pain interference on their daily life.
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.	Secondary outcomes included the pain interference on their enjoyment of life.

Trial Locations

Locations (1)

Tianjin Medical University General Hospital; 🇨🇳 Tianjin, China