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

Sponsor
Tianjin Medical University (Other)
Overall Status
Completed
CT.gov ID
NCT05926817
Collaborator
(none)
45
1
3
16.6
2.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: 2D-video glasses
  • Device: 3D-VR headsets
N/A

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 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
45 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Effect of Virtual Reality Intervention on Hospitalized Patients With Acute Pain After Thoracoscopic Surgery: A Randomized Clinical Trial
Actual Study Start Date :
Oct 19, 2021
Actual Primary Completion Date :
Mar 6, 2023
Actual Study Completion Date :
Mar 7, 2023

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Control group

Postoperative conventional analgesia was administered to patients in the control group.

Placebo Comparator: Placebo group

Patients watched a 15-minute relaxation-based movie on 2D-video glasses along with receiving conventional analgesia.

Device: 2D-video glasses
Patients in the placebo group watched a 15-minute relaxation-based movie on 2D-video glasses along with receiving conventional analgesia.

Experimental: VR group

Patients had to participate in 15-minute interactive games wearing 3D-VR headsets along with receiving conventional analgesia.

Device: 3D-VR headsets
Patients in the VR group had to participate in 15-minute interactive games wearing 3D-VR headsets along with receiving conventional analgesia.

Outcome Measures

Primary Outcome Measures

  1. Change in Pain intensity evaluating by the numerical rating scale (NRS) [Evaluating pain intensity among postoperative patients 10 minutes prior to and 30 minutes following the intervention]

    The primary outcome was the change in pain intensity following the VR and video glasses intervention.

Secondary Outcome Measures

  1. Pain-related interference on patients' mood by the brief pain inventory (BPI) [The patients' pain interference was evaluated within 30 minutes of the intervention.]

    Secondary outcomes included the pain interference on their mood.

  2. Pain-related interference on patients' sleep by the brief pain inventory (BPI) [The patients' pain interference was evaluated within 30 minutes of the intervention.]

    Secondary outcomes included the pain interference on their sleep.

  3. Pain-related interference on patients' daily life by the brief pain inventory (BPI) [The patients' pain interference was evaluated within 30 minutes of the intervention.]

    Secondary outcomes included the pain interference on their daily life.

  4. Pain-related interference on patients' interest in life by the brief pain inventory (BPI) [The patients' pain interference was evaluated within 30 minutes of the intervention.]

    Secondary outcomes included the pain interference on their interest in life.

  5. Pain-related interference on patients' walking ability by the brief pain inventory (BPI) [The patients' pain interference was evaluated within 30 minutes of the intervention.]

    Secondary outcomes included the pain interference on their walking ability.

  6. Patient satisfaction regarding the VR by the satisfaction evaluation form [We assessed patient satisfaction with VR after the end of the third day of the VR intervention.]

    Secondary outcomes included patient satisfaction regarding the VR intervention.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Tianjin Medical University General Hospital Tianjin China 300052

Sponsors and Collaborators

  • Tianjin Medical University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Weibo Cao, Principal investigator, Tianjin Medical University
ClinicalTrials.gov Identifier:
NCT05926817
Other Study ID Numbers:
  • IRB2021-YX-173-01
First Posted:
Jul 3, 2023
Last Update Posted:
Jul 3, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 3, 2023