Clinical trial NCT05926817: Effect of Virtual Reality on Patients With Acute Pain After Thoracoscopic Surgery
Official title: Effect of Virtual Reality Intervention on Hospitalized Patients With Acute Pain After Thoracoscopic Surgery: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Virtual Reality
Acute Postoperative Pain
Thoracic Surgery, Video-Assisted
Lead sponsor: Tianjin Medical University
Sponsor class: OTHER
First posted: 2023-07-03
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Pain intensity evaluating by the numerical rating scale (NRS)
timeFrame: Evaluating pain intensity among postoperative patients 10 minutes prior to and 30 minutes following the intervention
Secondary outcomes:
measure: Pain-related interference on patients' mood by the brief pain inventory (BPI)
timeFrame: The patients' pain interference was evaluated within 30 minutes of the intervention.
measure: Pain-related interference on patients' sleep by the brief pain inventory (BPI)
timeFrame: The patients' pain interference was evaluated within 30 minutes of the intervention.
measure: Pain-related interference on patients' daily life by the brief pain inventory (BPI)
timeFrame: The patients' pain interference was evaluated within 30 minutes of the intervention.
measure: Pain-related interference on patients' interest in life by the brief pain inventory (BPI)
timeFrame: The patients' pain interference was evaluated within 30 minutes of the intervention.
measure: Pain-related interference on patients' walking ability by the brief pain inventory (BPI)
timeFrame: The patients' pain interference was evaluated within 30 minutes of the intervention.
measure: Patient satisfaction regarding the VR by the satisfaction evaluation form
timeFrame: We assessed patient satisfaction with VR after the end of the third day of the VR intervention.
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
Study officials:
affiliation: Tianjin Medical University General Hospital
name: Song Xu
role: STUDY_DIRECTOR
References: