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

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

2D-video glasses

3D-VR headsets

About this trial

This is an interventional treatment trial for Virtual Reality

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: The patient's age is ≥ 18, regardless of gender. Within one day after thoracoscopic surgery. The NRS of postoperative pain is ≥ four. Having specific internet knowledge and mobile phone reading and writing abilities. Patients voluntarily sign the informed consent form and are willing to complete the follow-up according to the trial protocol. Exclusion Criteria: Patients have severe cognitive disorders. Patients with previous diagnoses of epilepsy, dementia, migraine, or other neurological diseases may have difficulty using the VR headset. Patients are sensitive to light stimulation. Patients are without stereopsis or with severe hearing impairment. Patients with trauma to the eyes, face, or neck are not comfortable using VR headsets. Patients have severe heart, liver, kidney, blood, digestive, and nervous diseases. Patients previously used the VR headset but found it ineffective. Patients have a history of severe alcoholism, long-term heavy drinking, and symptoms of alcohol dependence. Patients have participated in any analgesic intervention study in the past week. Women have pregnancy plans during the follow-up period of the study. Patients and their families work in digital health or pharmaceutical companies for acute or chronic pain management. Patients cannot use electronic devices such as smartphones.

Sites / Locations

Tianjin Medical University General Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Placebo Comparator

Experimental

Arm Label

Control group

Placebo group

VR group

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Change in Pain intensity evaluating by the numerical rating scale (NRS)

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

Secondary Outcome Measures

Pain-related interference on patients' mood by the brief pain inventory (BPI)

Secondary outcomes included the pain interference on their mood.

Pain-related interference on patients' sleep by the brief pain inventory (BPI)

Secondary outcomes included the pain interference on their sleep.

Pain-related interference on patients' daily life by the brief pain inventory (BPI)

Secondary outcomes included the pain interference on their daily life.

Pain-related interference on patients' interest in life by the brief pain inventory (BPI)

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

Pain-related interference on patients' walking ability by the brief pain inventory (BPI)

Secondary outcomes included the pain interference on their walking ability.

Patient satisfaction regarding the VR by the satisfaction evaluation form

Secondary outcomes included patient satisfaction regarding the VR intervention.

Full Information

NCT ID

NCT05926817

First Posted

June 14, 2023

Last Updated

June 23, 2023

Sponsor

Tianjin Medical University

1. Study Identification

Unique Protocol Identification Number

NCT05926817

Brief Title

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

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Completed

Study Start Date

October 19, 2021 (Actual)

Primary Completion Date

March 6, 2023 (Actual)

Study Completion Date

March 7, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Tianjin Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

45 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Control group

Arm Type

No Intervention

Arm Description

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

Arm Title

Placebo group

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

VR group

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

2D-video glasses

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

3D-VR headsets

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in Pain intensity evaluating by the numerical rating scale (NRS)

Description

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

Time Frame

Evaluating pain intensity among postoperative patients 10 minutes prior to and 30 minutes following the intervention

Secondary Outcome Measure Information:

Title

Pain-related interference on patients' mood by the brief pain inventory (BPI)

Description

Secondary outcomes included the pain interference on their mood.

Time Frame