Virtual RealityNCT03922009
The Effect of Virtual Reality on Patients With Anxiety Over Surgeries Under Spinal Anesthesia
A study testing Virtual Reality in people with Virtual Reality, run by National Yang Ming Chiao Tung University Hospital at 1 site in Taiwan.
Trial summary
The main purposes of this study are as follows: First, to understand the effect of virtual reality on the subjective feelings of anxiety in patients with orthopaedic lower limb surgery for spinal anesthesia. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Virtual Reality
- What is being tested?
- Virtual Reality
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jun 2018to 1 Jun 2019
- 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 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- population: acceptance of lower extremity fractures in patients with spinal anesthesia.
- Anesthesia classification (ASA): I-III.
- Age: 20 years old to 70 years of age.
Who cannot join
- Mental illness and taking related drugs.
- Visually impaired and hearing impaired.
- Being unable to communicate or illiterate.
- The condition changes or is critical, and the intensive care unit is admitted after the operation.
- Contact isolation.
- Trauma of the head and wounds on the head.
- History of motion sickness and vertigo.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Virtual Reality on Patients With Anxiety Over Surgeries Under Spinal Anesthesia-A Case Study of Orthopedic Lower Limb Surgery
The main purposes of this study are as follows:
First, to understand the effect of virtual reality on the subjective feelings of anxiety in patients with orthopaedic lower limb surgery for spinal anesthesia.
Second, to understand the effects of virtual reality on the systolic blood pressure, diastolic blood pressure, mean arterial pressure, heartbeat, respiration and other physiological parameters in the operation of orthopedic lower extremity surgery patients with spinal anesthesia.
Third, to understand the effect of using virtual reality in surgery to reduce the use of sedative drugs and the degree of pain in patients with orthopedic lower extremity surgery.
Read the detailed description
Surgery is a serious source of stress for the general patient and can increase the patient's anxiety. which is It is normal to show obvious anxiety in patients undergoing surgery, but if the degree of anxiety is serious, it may lead Negative physiological manifestations, such as slow wound healing, increase the risk of infection and may affect the induction of anesthesia It requires more anesthesia dose during surgery, which hinders recovery time. Most studies have confirmed surgery Playing music in the room can alleviate the anxiety and pain of the patients, but the music preference is subjective and some people like it.
There must be people who hate it, and the operating room is not a quiet space. There are many sound sources in the operating room., such as the sound of surgical instruments, the warning sound of physiological monitors, the voice of the staff, these It will be a source of anxiety for patients. Instrument noise averages up to 60 decibels, including neurosurgery, orthopedics It can even exceed 100 decibels. Foreign scholars believe that playing music at this time will only aggravate the noisy environment.The attention of the staff. Therefore, it is hoped that by using virtual reality to provide images and sounds during surgery, hijacking The patient's auditory, visual, and proprioception creates an immersive, distracting approach that reduces the cause of the ring Anxiety brought by the environment helps spinal anesthesia patients to reduce anxiety during surgery and increase psychological comfort To reduce the use of sedative drugs during surgery.
- Conditions
- Virtual Reality
- Being tested
- Virtual Reality
- Keywords
- Virtual Reality；Anxiety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual RealityDevice
The primary objective of this study was to evaluate the use of VR to reduce anxiety in spinal anesthesia patients compared with controls
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality group | Experimental | The primary objective of this study was to evaluate the use of VR to reduce anxiety in spinal anesthesia patients compared with controls Receives: Device: Virtual Reality |
| control group | No intervention | General routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety
First, to understand the effect of virtual reality on the subjective feelings of anxiety in patients with orthopaedic lower limb surgery for spinal anesthesia.USE State-Trait Anxiety Inventory；STAI
Measured: After anesthesia until the end of surgery(intraoperative )
Secondary outcomes (3)
physiological parameters
Second, to understand the effects of virtual reality on the mean arterial pressure physiological parameters in the operation of orthopedic lower extremity surgery patients with spinal anesthesia.
Measured: After anesthesia until the end of surgery(intraoperative )
physiological parameters
Second, to understand the effects of virtual reality on the heartbeat physiological parameters in the operation of orthopedic lower extremity surgery patients with spinal anesthesia.
Measured: After anesthesia until the end of surgery(intraoperative )
physiological parameters
Second, to understand the effects of virtual reality on the respiration physiological parameters in the operation of orthopedic lower extremity surgery patients with spinal anesthesia.
Measured: After anesthesia until the end of surgery(intraoperative )
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2019
- Study start1 Jun 2018
- Primary completion1 Jun 2019
- Study completion1 Jun 2019
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 50 people in the control group 50 people in the experimental group
- Masking
- None (open label)
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Yang Ming Chiao Tung University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, YANG,HSIN-CHIEH, National Yang Ming Chiao Tung University Hospital
- Investigators
- HSIN-CHIEH YANG, Bachelor, Principal investigator, National Yang Ming Chiao Tung University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03922009
- Sponsor's protocol ID
- NYMUH-IRB No.2018A015
- Status last verified
- Aug 2019
- First submitted
- 19 Jan 2019
- Last updated
- 3 Sep 2019
- Results posted
- No
- Data monitoring committee
- 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 3 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Virtual Reality on Patients With Anxiety Over Surgeries Under Spinal Anesthesia-A Case Study of Orthopedic Lower Limb Surgery
- ClinicalTrials.gov ID
- NCT03922009
- Acronym / sponsor ID
- NYMUH-IRB No.2018A015
- Conditions
- Virtual Reality
- Keywords
- Virtual Reality；Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- National Yang Ming Chiao Tung University HospitalUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 1 Jun 2019 (actual)
- First posted
- 19 Apr 2019 (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.
The main purposes of this study are as follows:
First, to understand the effect of virtual reality on the subjective feelings of anxiety in patients with orthopaedic lower limb surgery for spinal anesthesia.
Second, to understand the effects of virtual reality on the systolic blood pressure, diastolic blood pressure, mean arterial pressure, heartbeat, respiration and other physiological parameters in the operation of orthopedic lower extremity surgery patients with spinal anesthesia.
Third, to understand the effect of using virtual reality in surgery to reduce the use of sedative drugs and the degree of pain in patients with orthopedic lower extremity surgery.
Detailed description
Surgery is a serious source of stress for the general patient and can increase the patient's anxiety. which is It is normal to show obvious anxiety in patients undergoing surgery, but if the degree of anxiety is serious, it may lead Negative physiological manifestations, such as slow wound healing, increase the risk of infection and may affect the induction of anesthesia It requires more anesthesia dose during surgery, which hinders recovery time. Most studies have confirmed surgery Playing music in the room can alleviate the anxiety and pain of the patients, but the music preference is subjective and some people like it.
There must be people who hate it, and the operating room is not a quiet space. There are many sound sources in the operating room., such as the sound of surgical instruments, the warning sound of physiological monitors, the voice of the staff, these It will be a source of anxiety for patients. Instrument noise averages up to 60 decibels, including neurosurgery, orthopedics It can even exceed 100 decibels. Foreign scholars believe that playing music at this time will only aggravate the noisy environment.The attention of the staff. Therefore, it is hoped that by using virtual reality to provide images and sounds during surgery, hijacking The patient's auditory, visual, and proprioception creates an immersive, distracting approach that reduces the cause of the ring Anxiety brought by the environment helps spinal anesthesia patients to reduce anxiety during surgery and increase psychological comfort To reduce the use of sedative drugs during surgery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 50 people in the control group 50 people in the experimental group
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality group | Experimental | Device: Virtual RealityThe primary objective of this study was to evaluate the use of VR to reduce anxiety in spinal anesthesia patients compared with controls |
| control group | No intervention | –General routine care |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- population: acceptance of lower extremity fractures in patients with spinal anesthesia.
- Anesthesia classification (ASA): I-III.
- Age: 20 years old to 70 years of age.
Key exclusion criteria (7 listed)
- Mental illness and taking related drugs.
- Visually impaired and hearing impaired.
- Being unable to communicate or illiterate.
- The condition changes or is critical, and the intensive care unit is admitted after the operation.
- Contact isolation.
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 |
|---|---|---|
| Virtual RealityThe primary objective of this study was to evaluate the use of VR to reduce anxiety in spinal anesthesia patients compared with controls | Device | Virtual Reality group |
Primary outcome
Anxiety
Time frame: After anesthesia until the end of surgery(intraoperative )
First, to understand the effect of virtual reality on the subjective feelings of anxiety in patients with orthopaedic lower limb surgery for spinal anesthesia.USE State-Trait Anxiety Inventory；STAI
3 secondary outcomes
physiological parameters
Time frame: After anesthesia until the end of surgery(intraoperative )
physiological parameters
Time frame: After anesthesia until the end of surgery(intraoperative )
physiological parameters
Time frame: After anesthesia until the end of surgery(intraoperative )
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 3 Sep 2019.
- 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.
HSIN-CHIEH YANG, Bachelor principal investigator
National Yang Ming Chiao Tung University 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 Virtual Reality in people with Virtual Reality, run by National Yang Ming Chiao Tung University Hospital at 1 site in Taiwan.
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 3 inclusion and 7 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 3 Sep 2019. 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 Taiwan. 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. 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?
Anxiety (time frame: After anesthesia until the end of surgery(intraoperative )). 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 3 Sep 2019.