Virtual RealityNCT05926817
Effect of Virtual Reality on Patients With Acute Pain After Thoracoscopic Surgery
A study testing QTC-VR headsets in people with Virtual Reality and Acute Postoperative Pain, run by Tianjin Medical University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Virtual Reality, Acute Postoperative Pain, Thoracic Surgery, Video-Assisted
- What is being tested?
- QTC-VR headsets
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 61 participants
- Where
- 1 siteChina
- Study dates
- 19 Oct 2021to 7 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Placebo-VR headsets, QTC-VR headsets
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo-VR headsetsDevice
Patients in the Placebo-VR group watched a 10-minute relaxation-based 2D film through VR headsets along with receiving conventional analgesia.
QTC-VR headsetsDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Postoperative standard analgesia was administered to patients in the control group. |
| Placebo-VR group | Placebo comparator | Patients in the Placebo-VR group watched a 10-minute relaxation-based 2D film through VR headsets along with receiving conventional analgesia. Receives: Device: Placebo-VR headsets |
| QTC-VR group | Experimental | 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. Receives: Device: QTC-VR headsets |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Evaluating pain intensity among postoperative patients 10 minutes prior to and 30 minutes following the intervention
Secondary outcomes (6)
Pain-related interference on patients' mood by the brief pain inventory (BPI)
Secondary outcomes included the pain interference on their mood.
Measured: 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.
Measured: 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.
Measured: The patients' pain interference was evaluated within 30 minutes of the 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.
Measured: 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.
Measured: 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.
Measured: We assessed patient satisfaction with VR after the end of the third day of the VR intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start19 Oct 2021
- Primary completion6 Mar 2023
- Study completion7 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Virtual RealityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tianjin Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weibo Cao, Tianjin Medical University
- Investigators
- Song Xu, Study director, Tianjin Medical University General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05926817
- Sponsor's protocol ID
- IRB2021-YX-173-01
- Status last verified
- Feb 2024
- First submitted
- 14 Jun 2023
- Last updated
- 5 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Virtual Reality Intervention on Hospitalized Patients With Acute Pain After Thoracoscopic Surgery: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05926817
- Acronym / sponsor ID
- IRB2021-YX-173-01
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Tianjin Medical UniversityUniversity, hospital or other
- Study start
- 19 Oct 2021 (actual)
- Primary completion
- 6 Mar 2023 (actual)
- Study completion
- 7 Mar 2023 (actual)
- First posted
- 3 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Postoperative standard analgesia was administered to patients in the control group. |
| Placebo-VR group | Placebo comparator | Device: Placebo-VR headsetsPatients in the Placebo-VR group watched a 10-minute relaxation-based 2D film through VR headsets along with receiving conventional analgesia. |
| QTC-VR group | Experimental | Device: QTC-VR headsetsPatients in the QTC-VR group engaged in 10-minute interactive pain relief 3D VR programs while wearing VR headsets along with receiving conventional analgesia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo-VR headsetsPatients in the Placebo-VR group watched a 10-minute relaxation-based 2D film through VR headsets along with receiving conventional analgesia. | Device | Placebo-VR group |
| QTC-VR headsetsPatients 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 group |
Primary outcome
Change in Pain intensity evaluating by the numerical rating scale (NRS)
Time frame: 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 QTC-VR and Placebo-VR intervention.
6 secondary outcomes
Pain-related interference on patients' mood by the brief pain inventory (BPI)
Time frame: The patients' pain interference was evaluated within 30 minutes of the intervention.
Pain-related interference on patients' sleep by the brief pain inventory (BPI)
Time frame: 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)
Time frame: The patients' pain interference was evaluated within 30 minutes of the intervention.
Pain-related interference on patients' interest in life by the brief pain inventory (BPI)
Time frame: 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)
Time frame: The patients' pain interference was evaluated within 30 minutes of the intervention.
Patient satisfaction regarding the VR by the satisfaction evaluation form
Time frame: We assessed patient satisfaction with VR after the end of the third day of the VR intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Song Xu study director
Tianjin Medical University General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing QTC-VR headsets in people with Virtual Reality and Acute Postoperative Pain, run by Tianjin Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain intensity evaluating by the numerical rating scale (NRS) (time frame: Evaluating pain intensity among postoperative patients 10 minutes prior to and 30 minutes following the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2024.