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

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

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.

Study Overview

• Status: Completed
• Conditions: Acute Postoperative Pain; Virtual Reality; Thoracic Surgery, Video-Assisted
• Intervention / Treatment: Device: Placebo-VR headsets; Device: QTC-VR headsets

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 Type: Interventional
• Enrollment (Actual): 61
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Tianjin, China, 300052
    • Tianjin Medical University General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; Postoperative standard analgesia was administered to patients in the control group.
Placebo Comparator: 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.	Device: 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.
Experimental: 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.	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.

What is the study measuring?

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 QTC-VR and Placebo-VR 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' 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.
Pain-related interference on patients' interest in life by the brief pain inventory (BPI)	Secondary outcomes included the pain interference on their enjoyment of life.	The patients' pain interference was evaluated within 30 minutes of the intervention.

Collaborators and Investigators

• Sponsor: Tianjin Medical University
• Investigators: Study Director: Song Xu, Tianjin Medical University General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 19, 2021
• Primary Completion (Actual): March 6, 2023
• Study Completion (Actual): March 7, 2023

Study Registration Dates

• First Submitted: June 14, 2023
• First Submitted That Met QC Criteria: June 23, 2023
• First Posted (Actual): July 3, 2023

Study Record Updates

• Last Update Posted (Estimated): February 5, 2024
• Last Update Submitted That Met QC Criteria: February 2, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Acute Pain
• Other Study ID Numbers: IRB2021-YX-173-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No