Effect of virtual reality intervention on hospitalized patients with acute pain after thoracoscopic surgery: a pilot randomized clinical trial

Abstract

The study investigates the effectiveness of immersive virtual reality (VR) as a nonpharmaceutical approach to manage postoperative pain in patients following thoracoscopic surgery. In this single-center, triple-arm pilot randomized controlled trial (RCT), 61 postsurgical patients with a postoperative pain numerical rating scale (NRS) score ≥4 after receiving standard analgesia were included and assigned to either a quantum clinics-VR (QTC-VR) group, a Placebo-VR group, or a control group. The QTC-VR group engaged in a daily 10-minute interactive pain relief 3D-VR program, while the Placebo-VR group watched a daily 10-minute relaxation-based 2D film through VR headsets for three days following surgery. 61 postsurgical patients were randomized and allocated (21 in the QTC-VR group, 20 in the Placebo-VR group, and 20 in the control group) in the final intention-to-treat (ITT) analyses. Compared with patients receiving Placebo-VR intervention, patients reported significantly lower pain scores following the daily QTC-VR intervention on postoperative days 1 (mean difference, −0.889; 95% CI, −1.464 to −0.314; P < 0.001), 2 (mean difference, −0.631; 95% CI, −1.211 to −0.051; P = 0.014), and 3 (mean difference, −0.798; 95% CI, −1.345 to −0.251; P < 0.001), respectively. Additionally, patients receiving QTC-VR intervention also reported high satisfaction and tolerable adverse events with their treatment. In conclusion, this pilot RCT demonstrates that QTC-VR might be a promising intervention for pain management post-thoracoscopic surgery, warranting further validation in ongoing phase III trials.

Introduction

Video-assisted thoracoscopic surgery (VATS) has become the preferred surgical modality for early-stage non-small cell lung cancer (NSCLC) due to its rapid postoperative recovery and improved quality of life^[1]. While VATS patients experience less postoperative pain compared to those undergoing traditional thoracotomy, acute pain remains a common issue that can lead to complications and delayed recovery^[2,3]. Analgesic medications are typically used for pain management; however, they carry risks of adverse effects such as nausea and respiratory depression, prompting the exploration of non-pharmacological interventions.

Recently, virtual reality (VR) as an emerging nonpharmaceutical therapeutic modality has shown promise in reducing pain in postsurgical contexts^[4]. In this study, we conducted a pilot randomized controlled trial (RCT) to evaluate the effectiveness of VR in alleviating postoperative pain and pain interference items for patients undergoing VATS.

Methods

We conducted a single-center and pilot RCT from October 2021 to March 2023. The Institutional Review Board (IRB) approved the pilot RCT, which was registered at ClinicalTrials.gov. The trial was reported in compliance with the Consolidated Standards of Reporting Trials (CONSORT) Guidelines^[5].

Postoperative patients with a numerical rating scale (NRS) score ≥4 for postoperative pain were included. Patients were randomized 1:1:1 and allocated to one of three groups: (1) Quantum Clinics-VR (QTC-VR) group: a 3-day pain relief VR program. (2) Placebo-VR group: a 3-day placebo VR program. (3) Control group: a 3-day pain score survey program. A software-generated randomization program was used to apply an automatic and random allocation in a 1:1:1 ratio to all three groups. Patients in the control group acquired standard postoperative analgesia, while patients in the QTC-VR and Placebo-VR groups received VR therapies using the Pico Neo3 all-in-one head-mounted VR device (Supplementary Figure 1, http://links.lww.com/JS9/D833) combined with standard postoperative analgesia. Supplementary Table 1 (http://links.lww.com/JS9/D836) provides an overview of the trial procedure.

The primary outcome was the changes in pain intensity following daily QTC-VR and Placebo-VR interventions within three days after surgery. Secondary outcomes included patient satisfaction regarding the QTC-VR intervention and daily pain interference on patient emotion, sleep, enjoyment of life, walking ability, relations with others, and general activity three days following surgery. These pain interference items were evaluated utilizing the brief pain inventory (Supplementary Table 2, http://links.lww.com/JS9/D837). The detailed information regarding the trial design, inclusion and exclusion criteria, analgesic medications, randomization and blinding, VR interventions, outcome measures, and statistical analyses is provided in Supplementary Text 1 (http://links.lww.com/JS9/D839).

Results

Patient recruitment and characteristics

A total of 61 eligible patients were randomized in the final analyses according to the intention-to-treat (ITT) principle (Fig. 1). The baseline demographics and clinical features for patients are summarized in Table 1. Among included patients, the median (IQR) age was 61 (54–68) years, and the majority were female (37 of 61 [60.7%]). Of the 61 patients randomized, 36 (59%) underwent sublobectomy, 23 (37.7%) received lobectomy, and the remaining two (3.3%) underwent other surgical modalities.

Figure 1.

Flow diagram of patient recruitment in the clinical trial.

Table 1.

Patient baseline demographics and clinical characteristics in the QTC-VR, Placebo-VR, and control groups

Variable	Interventions
	QTC-VR (n = 21)	Placebo-VR (n = 20)	Control (n = 20)	P value
Age (years), median (IQR)	60.00 (49.50–69.00)	62.00 (54.00–67.75)	64.50 (57.25–67.75)	0.697
Sex, n (%)				0.249
Male	9 (42.86)	10 (50.00)	5 (25.00)
Female	12 (57.14)	10 (50.00)	15 (75.00)
Education, n (%)				0.645
Postgraduate	0	1 (5.00)	0
Undergraduate	5 (23.80)	4 (20.00)	3 (15.00)
Senior high school student	8 (38.10)	4 (20.00)	8 (40.00)
Primary/Junior high school student	8 (38.10)	11 (55.00)	9 (45.00)
Smoking status, n (%)				0.781
Never smokers	15 (71.43)	13 (65.00)	15 (75.00)
Ever or current smokers	6 (28.57)	7 (35.00)	5 (25.00)
Thoracoscopic surgical modalities, n (%)				0.657
Lobectomy	7 (33.33)	7 (35.00)	9 (45.00)
Sublobectomy	14 (66.67)	12 (60.00)	10 (50.00)
Mediastinal lymph node biopsy	0	0	1 (5.00)
Mediastinal lesion resection	0	1 (5.00)	0
Baseline NRS scores, median (IQR)	4.00 (4.00–5.00)	4.50 (4.00–5.00)	4.00 (4.00–5.00)	0.249

VR: virtual reality; QTC-VR: quantum clinics-VR; NRS: numerical rating scale; IQR: interquartile range.

Changes in pain intensity following intervention

The postoperative changes in the daily pain scores among the three groups are illustrated in Figure 2 and Supplementary Table 3 (http://links.lww.com/JS9/D838). Prior to the VR interventions, there were no statistically significant differences in pain intensity between the QTC-VR and Placebo-VR groups. However, patients who underwent daily QTC-VR intervention reported significantly lower pain scores on postoperative days 1 (mean difference, −0.889; 95% CI, −1.464 to −0.314; P < 0.001), 2 (mean difference, −0.631; 95% CI, −1.211 to −0.051; P = 0.014), and 3 (mean difference, −0.798; 95% CI, −1.345 to −0.251; P < 0.001) compared with patients following Placebo-VR intervention.

Figure 2.

Changes in pain intensity daily for all patients in the QTC-VR, Placebo-VR, and control groups before and after 3-day postoperative interventions. VR, virtual reality; QTC-VR, quantum clinics-VR.

Pain interference items following intervention

Pain-related interference with emotion, sleep, enjoyment of life, walking ability, relations with others, and general activity among the three groups following thoracoscopic surgery is shown in Supplementary Figure 2 (http://links.lww.com/JS9/D834). Compared to those in the Placebo-VR group, significant differences were noted for patients receiving QTC-VR intervention on postoperative days 2 (mean difference, −1.360; 95% CI, −2.697 to −0.022; P = 0.042) and 3 (mean difference, −1.433; 95% CI, −2.730 to −0.137; P = 0.015) for enjoyment of life, and on day 3 for emotion (mean difference, −1.826; 95% CI, −3.134 to −0.519; P < 0.001), sleep (mean difference, −1.336; 95% CI, −2.573 to −0.099; P = 0.020), walking ability (mean difference, −1.643; 95% CI, −3.248 to −0.037; P = 0.039), and relations with others (mean difference, −1.793; 95% CI, −3.158 to −0.427; P = 0.001).

Patient satisfaction and adverse events

Patients receiving QTC-VR therapies reported a significant degree of satisfaction with their treatment. Specifically, 71.4% and 81% of participants consider the operational feasibility and visual perception of QTC-VR to be satisfactory. Notably, 90.5% expressed satisfaction with QTC-VR, expressing a willingness or considering to reuse it (Supplementary Figure 3, http://links.lww.com/JS9/D835).

While patients who participated in the postoperative QTC-VR intervention did experience mild vertigo and nausea, there were no statistically significant differences in these adverse events between the QTC-VR and Placebo-VR groups (P = 0.429).

Discussion

Postoperative pain remains one of the most prevalent complications among patients undergoing thoracoscopic surgery^[2]. Immersive VR intervention, an emerging nonpharmaceutical therapeutic modality, can effectively alleviate surgery-related acute pain in postsurgical patients^[6]. In this pilot RCT involving 61 participants, those in the QTC-VR group experienced significant reductions in postoperative pain intensity compared with the Placebo-VR and control groups. Moreover, patients with QTC-VR intervention reported high satisfaction and tolerable adverse events. The underlying mechanisms of QTC-VR intervention in pain alleviation have not been unified, while interactive distraction, emotion regulation, and neurophysiological changes may be involved^[7–10].

To our knowledge, this is the first pilot RCT that confirms the potential efficacy and feasibility of immersive VR intervention in acute pain management for hospitalized patients after VATS. However, it is important to acknowledge the limitations of this RCT, which include the control group blinding, the necessity for an increased sample size and further optimization of the duration for the VR intervention. Future large-scale, multicenter prospective clinical trials are warranted to facilitate an individualized VR environment for pain management among postoperative patients.

Ethical approval

The ethical committee of Tianjin Medical University General Hospital authorized the pilot RCT, which was registered at ClinicalTrials.gov (NCT05926817). The Institutional Review Board (IRB) approved the pilot RCT, with the approval number IRB2021-YX-173-01.

Consent

The clinical trial obtained the ethics committee’s approval, and patients in the clinical trial signed informed consent forms (ICFs).

Sources of funding

This study was funded by the National Key R&D Program of China (2023YFC3605204 and 2023YFC2508604), Major Research Plan of National Natural Science Foundation of China (92163213), National Natural Science Foundation of China (82172776), Tianjin Health Research Project (TJWJ2023XK005), Diversified Input Project of Tianjin National Natural Science Foundation (21JCYBJC01770), Major Project of Strategic Research and Consulting of Chinese Academy of Engineering (2023-DFZD-58), and Tianjin Science and Technology Plan Project (21JCZDJC00940).

Author’s contribution

All authors participated in designing the clinical trial. S.Y., X.L., and C.C. performed the study. N.Z., H.L., H.Y., and F.M. took responsibility for acquiring the initial data. F.R., T.L., and F.M. conducted the statistical analyses. W.C. wrote the first draft. G.C., L.Z., and L.W. were responsible for supervising the study. Q.L., Y.Z., L.S., W.C., L.W., Y.Z., J.L., C.W., R.J., C.F., and L.Y. were in charge of the control of standard analgesic medications. Y.L. designed the QTC-VR software. The manuscript was revised by Q. Z. and S. X. All authors agreed on the final version of the manuscript.

Conflicts of interest disclosure

All the authors declare to have no conflicts of interest relevant to this study.

Research registration unique identifying number (UIN)

ClinicalTrials.gov Identifier: NCT05926817.

Guarantor

Song Xu.

Provenance and peer review

Not commissioned, externally peer-reviewed.

Data availability statement

The data should be available upon reasonable request.