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

Virtual Reality Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05926817
• Other study ID #: IRB2021-YX-173-01
• Status: Completed
• Phase: N/A
• Start date: October 19, 2021
• Est. completion date: March 7, 2023

Study information

• Verified date: February 2024
• Source: Tianjin Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: March 7, 2023
• Est. primary completion date: March 6, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Tianjin Medical University General Hospital	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.