VIRTUAL REALITYVRNCT03475810
The Effect of Virtual Reality Glasses on Anxiety During Surgery Under Spinal Anesthesia
A study testing Virtual Reality and Midazolam in people with VIRTUAL REALITY, run by Derince Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study is to evaluate the efficacy of virtual reality glasses on anxiety of the patients who underwent operations under spinal anesthesia during peroperative period. Both control group and VR group will be carry out STAI- Traıt anxiety test before operation and trait test after operation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- VIRTUAL REALITY
- What is being tested?
- Virtual Reality and Midazolam
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Nov 2017to 1 Jul 2018
- 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
- Age >18
- Patients who undergo surgery under spinal anesthesia
- American Society of Anesthesiologists (ASA) physical status classification I-III
Who cannot join
- patients undergo urgent operations
- patients have psychiatric disorders
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Derince Research and Training Hospital
Kocaeli, 41900
About this study
Official title: The Effect of Virtual Reality Glasses on Anxiety During Surgery Under Spinal Anesthesia: A Randomize Controlled Study
The aim of the study is to evaluate the efficacy of virtual reality glasses on anxiety of the patients who underwent operations under spinal anesthesia during peroperative period. Both control group and VR group will be carry out STAI- Traıt anxiety test before operation and trait test after operation. Patients will be perform spinal anesthesia after standard sedation administration. After block reach adequate level for operation patients in VR group will wear the glasses and started to watch a documentary about birds and a sedative music by the headset. Patients in Control group will take standard anesthesia care. Hemodynamic changes (systemic blood pressure, heart rate, respiration rate and pSPO2) will be record in both groups.
Read the detailed description
The ASA score I-III Patients undergoing operation in OR under spinal anesthesia will be included in the study. Patients randomly assigned to VR group or Control Group. Patients will be carry out STAI-Trait Anxiety test preoperatively and second STAI test postoperatively. Spinal anesthesia will be performed after standard iv midazolam administration in both groups. After block reach adequate level for operation patient will wear the glasses and started to watch a documentary about birds and a sedative music by the headset in VR group and patient will take standard anesthesia care in Control group. The hemodynamic variables will be recorded during operation.
- Conditions
- VIRTUAL REALITY
- Being tested
- Virtual Reality, Midazolam
- Keywords
- VIRTUAL REALITY, ANXIETY, SPINAL ANESTHESIA
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual RealityDevice
Also called VR
Patients will wear virtual reality glasses and start watching 3 D video after confirmation of adequate motor and sensorial block.
MidazolamDrug
Also called Demizolam
1-2 mg midazolam will be administered before spinal punction performed.
| Study group | Role | What they receive |
|---|---|---|
| VR GROUP | Experimental | Patients watches 3D documentary videos on virtual reality glasses Receives: Device: Virtual Reality; Drug: Midazolam |
| midazolam | Active comparator | Patients do not watch virtual reality videos but will be administered iv sedative drugs before spinal attempt. Receives: Drug: Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
State Anxiety Test
State Anxiety test will be perform at postop care unit
Measured: postoperative 20th min.
Secondary outcomes (18)
Total tolerance time of Virtual Reality glasses
Total tolerance to VR glasses will be recorded
Measured: intraoperative
incidence of vomiting
incidence of vomiting due to VR glasses
Measured: intraoperative
incidence of nausea
incidence of nausea due to VR glasses
Measured: intraoperative
incidence of dizziness
incidence of dizziness due to VR glasses
Measured: intraoperative
incidence of headache
incidence of headache due to VR glasses
Measured: intraoperative
Postoperative Visual Analog Scale Score
Patient will be asked his anxiety level by Visual analog scale (VAS) from 0 to 10. 0(= no anxiety), 10(= highest level of anxiety)
Measured: postoperative 20 th min.
change in mean arterial pressure
blood pressure of the patient will be measured noninvasively from proper extremity in the operating room
Measured: 5th min. intraoperative
change in mean arterial pressure
blood pressure of the patient will be measured noninvasively from proper extremity in the operating room
Measured: 10th min. intraoperative
change in mean arterial pressure
blood pressure of the patient will be measured noninvasively from proper extremity in the operating room
Measured: 15th min. intraoperative
change in mean arterial pressure
blood pressure of the patient will be measured noninvasively from proper extremity in the operating room
Measured: 20th min. intraoperative
change in heart rate
heart rate of the patient will be monitored and recorded
Measured: 5th min. intraoperative
change in heart rate
heart rate of the patient will be monitored and recorded
Measured: 10th min. intraoperative
change in heart rate
heart rate of the patient will be monitored and recorded
Measured: 15th min. intraoperative
change in heart rate
heart rate of the patient will be monitored and recorded
Measured: 20th min. intraoperative
change in respiratory rate
respiratory rate of the patient will be monitored and recorded
Measured: 5th min. intraoperative
change in respiratory rate
respiratory rate of the patient will be monitored and recorded
Measured: 10th min. intraoperative
change in respiratory rate
respiratory rate of the patient will be monitored and recorded
Measured: 15th min. intraoperative
change in respiratory rate
respiratory rate of the patient will be monitored and recorded
Measured: 20th min. intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2018
- Study start7 Nov 2017
- Primary completion1 Jul 2018
- Study completion1 Jul 2018
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
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Derince Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayse Zeynep Turan, Derince Training and Research Hospital
- Investigators
- Ayse Zeynep Turan, MD, Principal investigator, Derince Research and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03475810
- Sponsor's protocol ID
- DerinceTRH-02
- Acronym
- VR
- Status last verified
- Sep 2023
- First submitted
- 17 Mar 2018
- Last updated
- 7 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Virtual Reality Glasses on Anxiety During Surgery Under Spinal Anesthesia: A Randomize Controlled Study
- ClinicalTrials.gov ID
- NCT03475810
- Acronym / sponsor ID
- VR / DerinceTRH-02
- Conditions
- VIRTUAL REALITY
- Keywords
- VIRTUAL REALITY, ANXIETY, SPINAL ANESTHESIA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Derince Training and Research HospitalUniversity, hospital or other
- Study start
- 7 Nov 2017 (actual)
- Primary completion
- 1 Jul 2018 (actual)
- Study completion
- 1 Jul 2018 (actual)
- First posted
- 23 Mar 2018 (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 aim of the study is to evaluate the efficacy of virtual reality glasses on anxiety of the patients who underwent operations under spinal anesthesia during peroperative period. Both control group and VR group will be carry out STAI- Traıt anxiety test before operation and trait test after operation. Patients will be perform spinal anesthesia after standard sedation administration. After block reach adequate level for operation patients in VR group will wear the glasses and started to watch a documentary about birds and a sedative music by the headset. Patients in Control group will take standard anesthesia care. Hemodynamic changes (systemic blood pressure, heart rate, respiration rate and pSPO2) will be record in both groups.
Detailed description
The ASA score I-III Patients undergoing operation in OR under spinal anesthesia will be included in the study. Patients randomly assigned to VR group or Control Group. Patients will be carry out STAI-Trait Anxiety test preoperatively and second STAI test postoperatively. Spinal anesthesia will be performed after standard iv midazolam administration in both groups. After block reach adequate level for operation patient will wear the glasses and started to watch a documentary about birds and a sedative music by the headset in VR group and patient will take standard anesthesia care in Control group. The hemodynamic variables will be recorded during operation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VR GROUP | Experimental | Device: Virtual Reality, Drug: MidazolamPatients watches 3D documentary videos on virtual reality glasses |
| midazolam | Active comparator | Drug: MidazolamPatients do not watch virtual reality videos but will be administered iv sedative drugs before spinal attempt. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age >18
- Patients who undergo surgery under spinal anesthesia
- American Society of Anesthesiologists (ASA) physical status classification I-III
Key exclusion criteria (2 listed)
- patients undergo urgent operations
- patients have psychiatric disorders
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 RealityAlso: VRPatients will wear virtual reality glasses and start watching 3 D video after confirmation of adequate motor and sensorial block. | Device | VR GROUP |
| MidazolamAlso: Demizolam1-2 mg midazolam will be administered before spinal punction performed. | Drug | VR GROUP, midazolam |
Primary outcome
State Anxiety Test
Time frame: postoperative 20th min.
State Anxiety test will be perform at postop care unit
18 secondary outcomes
Total tolerance time of Virtual Reality glasses
Time frame: intraoperative
incidence of vomiting
Time frame: intraoperative
incidence of nausea
Time frame: intraoperative
incidence of dizziness
Time frame: intraoperative
incidence of headache
Time frame: intraoperative
Postoperative Visual Analog Scale Score
Time frame: postoperative 20 th min.
change in mean arterial pressure
Time frame: 5th min. intraoperative
change in mean arterial pressure
Time frame: 10th min. intraoperative
change in mean arterial pressure
Time frame: 15th min. intraoperative
change in mean arterial pressure
Time frame: 20th min. intraoperative
change in heart rate
Time frame: 5th min. intraoperative
change in heart rate
Time frame: 10th min. intraoperative
change in heart rate
Time frame: 15th min. intraoperative
change in heart rate
Time frame: 20th min. intraoperative
change in respiratory rate
Time frame: 5th min. intraoperative
change in respiratory rate
Time frame: 10th min. intraoperative
change in respiratory rate
Time frame: 15th min. intraoperative
change in respiratory rate
Time frame: 20th min. 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 7 Sep 2023.
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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.
Ayse Zeynep Turan, MD principal investigator
Derince Research and Training 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 and Midazolam in people with VIRTUAL REALITY, run by Derince Training and Research Hospital at 1 site in Turkey (Türkiye).
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 2 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 7 Sep 2023. 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 Turkey (Türkiye). 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?
State Anxiety Test (time frame: postoperative 20th min.). 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 7 Sep 2023.