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

Study Overview
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Brief Summary
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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
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Immersive virtual reality (VR) as a non-pharmaceutical technology may deliver effective behavioral therapies for postsurgical patients with acute pain. Patients in the VR group had to participate in 15-minute interactive games wearing 3D-VR headsets. 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 VR on pain relief in patients undergoing thoracoscopic surgery.

Official Title
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Effect of Virtual Reality Intervention on Hospitalized Patients With Acute Pain After Thoracoscopic Surgery: A Randomized Clinical Trial

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

Intervention / Treatment
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* Device: 2D-video glasses
* Device: 3D-VR headsets


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>Postoperative conventional analgesia was administered to patients in the control group. | |
| Placebo Comparator: Placebo group<br>Patients watched a 15-minute relaxation-based movie on 2D-video glasses along with receiving conventional analgesia. | Device: 2D-video glasses<br>* Patients in the placebo group watched a 15-minute relaxation-based movie on 2D-video glasses along with receiving conventional analgesia.<br>|
| Experimental: VR group<br>Patients had to participate in 15-minute interactive games wearing 3D-VR headsets along with receiving conventional analgesia. | Device: 3D-VR headsets<br>* Patients in the VR group had to participate in 15-minute interactive games wearing 3D-VR headsets along with receiving conventional analgesia.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pain intensity evaluating by the numerical rating scale (NRS) | The primary outcome was the change in pain intensity following the VR and video glasses intervention. | Evaluating pain intensity among postoperative patients 10 minutes prior to and 30 minutes following the intervention | 

Secondary Outcome Measures

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