AnxietyVRanxietyNCT06061198
Impact of Virtual Reality on Patient's Anxiety Who Underwent Surgery Uner Regional Anesthesia
A study testing a virtual reality device in people with Anxiety and Satisfaction, Patient, run by University Hospital, Mahdia at 1 site in Tunisia.
Trial summary
this study was conducted in TAHER SFAR Hospital . it included 68 patients and it aims to evaluate the impact of virtual reality on patients undergoing upper limb surgery under regional anesthesia and evaluate the consumption of hypnotics during surgery , anxiety levels and patients satisfaction. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Satisfaction, Patient
- What is being tested?
- a virtual reality device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteTunisia
- Study dates
- 1 Mar 2023to 18 May 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patient classified ASA 1 , 2 or 3
- patients undergoing an upper-limb surgery under regional anesthesia
Who cannot join
- regional anesthesia failure
- local anesthetics intoxications
- symptoms of cyber-sickness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Virtual Reality on Patient's Anxiety During Upper Limb Surgery Under Regional Anesthesia
this study was conducted in TAHER SFAR Hospital . it included 68 patients and it aims to evaluate the impact of virtual reality on patients undergoing upper limb surgery under regional anesthesia and evaluate the consumption of hypnotics during surgery , anxiety levels and patients satisfaction. this study contain 2 arms , each arm contain 34 patients . first arm received regional anesthesia and surgery under virtual reality using a VR gear . second arm received standard care
Read the detailed description
patients who had surgery with the virtual reality experience or the VR- group ( group of patients who had surgery with standard measures without virtual reality) The patient was setup comfortably on the operating table.The echo-guided regional anesthesia appropriate to the surgical procedure is performed by an experienced anesthesiologist.In the RV+ patients, loco regional anesthesia was performed before installing the VR mask and before initiating immersing in the virtual reality space. anesthesia protocol was performed before initiating VR experience to maintain audiovisual and cognitive contact with the patient and detect possible complications For the virtual reality immersion for the VR+ group, we used an OCULUS SAMSUNG GEAR VR, a virtual reality headset connected to a SAMSUNG S7 Edge phone with headphones.The headset was worn after the loco regional anesthesia and removed at the end of the procedure.The helmet is adapted to each patient according to his head circumference measurements and the image adjustment is personalized.The VR session consists of an immersion in a natural relaxation environment produced by an application downloaded from the OCULUS STORE: VR Guided Meditation.The application offers a choice of 4 environments: Relaxing day on a tropical beach, beautiful sunset beach, mountain sunrise, or forest nap experiences . The choice of the environment is randomized according to the patient's preferences.For patients who belongs to the VR- group, the procedure was performed under standard conditions with a drape separating the patient from the operating site During surgery, the vital signs: HR, PANI, SpO2 were collected at the different peri-operative moments respectively at the entrance to the operating room (T0), 15 minutes after ALR (T1), 30 minutes after ALR (T2), 30 minutes (T3), 1 hour (T4) and 2 hours (T5) An intraoperative assessment of anxiety was performed after 15 minutes of ALR, i.e. at T1 by the LIKERT scale The anesthesist could administer anxiolytics outside of the contraindications. The molecule of choice is Midazolam and the dose taken is noted on the data collection form The administration of anxiolytics (Midazolam) is judged by clinical criteria determined in the protocol:- Anxiety during the operation judged as painful or important (higher than2 on the LIKERT scale) The session can be interrupted during the procedure for medical reasons or at the patient's request.If the local anesthesia fails and the patient is converted to general anesthesia, the protocol is cancelled and a standard induction is performed by the anesthesiologist.The events of desaturation (SpO2 < 90%), apnea, administration of anxiolytics administration of anxiolytics (to reach a minimal level of anxiety) were indicated on the data collection form.For both RV+ and RV- groups, postoperative anxiety was assessed using the scores:1- Postoperative STAI at H1 postoperative2- patient satisfaction evaluated by a LIKERT scale
- Conditions
- Anxiety, Satisfaction, Patient
- Being tested
- a virtual reality device
- Keywords
- virtual reality, anxiety, patient satisfaction
- Medical subject headings
- Anxiety Disorders, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
a virtual reality deviceDevice
the patient will wear a masque tht will provide a virtual reality experience using a VR Gear connected to a mobile phone through an application installed on the mobile phone
| Study group | Role | What they receive |
|---|---|---|
| group of patients who underwent surgery with the virtual reality experience | Active comparator | patients underwent surgery wearing a virtual reality mask Receives: Device: a virtual reality device |
| patients who underwent surgery in standard conditions without the virtual reality experience | No intervention | patients underwent surgery without a virtual reality mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
hypnovel consumption during surgery
the required dose of Midazolam for a LIKERT intraoperative anxiety score goal < 2
Measured: From enrollment to the end of treatment at 10 weeks
Secondary outcomes (9)
satisfaction level during surgery
satisfaction levels measured with a LIKERT scale : 1 : not satisfied , 2: low satisfaction , 3:satisfied , 4: great satisfaction
Measured: at the end of the procedure
pre-operative patients's anxiety level by LIKERT score
pre operative anxiety measured with a LIKERT scale : 1= no anxiety , 2: tolerable anxiety , 3= anxious ; 4= hard experience
Measured: From enrollment to the end of treatment at 10 weeks
per-operative patients's anxiety level by LIKERT score
per operative anxiety measured with a LIKERT scale : 1= no anxiety , 2: tolerable anxiety , 3= anxious ; 4= hard experience
Measured: From enrollment to the end of treatment at 10 weeks
post-operative patients's anxiety level by LIKERT score
post operative anxiety measured with a LIKERT scale: 1= no anxiety , 2: tolerable anxiety , 3= anxious ; 4= hard experience
Measured: From enrollment to the end of treatment at 10 weeks
vitals : systolic pressure
vitals were monitored all long the procedure
Measured: From enrollment to the end of treatment at 10 weeks
vitals : heart rate
vitals were monitored all long the procedure
Measured: From enrollment to the end of treatment at 10 weeks
vitals : oxygen saturation
vitals were monitored all long the procedure
Measured: From enrollment to the end of treatment at 10 weeks
pre-operative patients's anxiety level by STAI-6 score
pre operative anxiety measured with a STAI-6 modified scale : a total score superior to 65 : high anxiety , score between 56-65 : too high anxiety , score between : 36 - 45 : low anxiety , score inferior to 35 no anxiety
Measured: From enrollment to the end of treatment at 10 weeks
post-operative patients's anxiety level by STAI-6 score
post operative anxiety measured with a STAI-6 modified scale : a total score superior to 65 : high anxiety , score between 56-65 : too high anxiety , score between : 36 - 45 : low anxiety , score inferior to 35 no anxiety
Measured: From enrollment to the end of treatment at 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2023
- Study start1 Mar 2023
- Primary completion18 May 2023
- Study completion18 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies 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
- 2 arms are involved in the study . first arm will receive local anesthesia with virtual reality during the surgery to reduce patient's anxiety . second arm will receive standards care under regional anesthesia
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Mahdia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Majdoub Ali MD, University Hospital, Mahdia
- Investigators
- Majdoub Ali MD, professor, Principal investigator, University Hospital, Mahdia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06061198
- Sponsor's protocol ID
- UHMahdia
- Acronym
- VRanxiety
- Status last verified
- Sep 2023
- First submitted
- 25 Aug 2023
- Last updated
- 29 Sep 2023
- 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 29 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Virtual Reality on Patient's Anxiety During Upper Limb Surgery Under Regional Anesthesia
- ClinicalTrials.gov ID
- NCT06061198
- Acronym / sponsor ID
- VRanxiety / UHMahdia
- Conditions
- Anxiety, Satisfaction, Patient
- Keywords
- virtual reality, anxiety, patient satisfaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- University Hospital, MahdiaUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 18 May 2023 (actual)
- Study completion
- 18 May 2023 (actual)
- First posted
- 29 Sep 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.
this study was conducted in TAHER SFAR Hospital . it included 68 patients and it aims to evaluate the impact of virtual reality on patients undergoing upper limb surgery under regional anesthesia and evaluate the consumption of hypnotics during surgery , anxiety levels and patients satisfaction. this study contain 2 arms , each arm contain 34 patients . first arm received regional anesthesia and surgery under virtual reality using a VR gear . second arm received standard care
Detailed description
patients who had surgery with the virtual reality experience or the VR- group ( group of patients who had surgery with standard measures without virtual reality) The patient was setup comfortably on the operating table.The echo-guided regional anesthesia appropriate to the surgical procedure is performed by an experienced anesthesiologist.In the RV+ patients, loco regional anesthesia was performed before installing the VR mask and before initiating immersing in the virtual reality space. anesthesia protocol was performed before initiating VR experience to maintain audiovisual and cognitive contact with the patient and detect possible complications For the virtual reality immersion for the VR+ group, we used an OCULUS SAMSUNG GEAR VR, a virtual reality headset connected to a SAMSUNG S7 Edge phone with headphones.The headset was worn after the loco regional anesthesia and removed at the end of the procedure.The helmet is adapted to each patient according to his head circumference measurements and the image adjustment is personalized.The VR session consists of an immersion in a natural relaxation environment produced by an application downloaded from the OCULUS STORE: VR Guided Meditation.The application offers a choice of 4 environments: Relaxing day on a tropical beach, beautiful sunset beach, mountain sunrise, or forest nap experiences . The choice of the environment is randomized according to the patient's preferences.For patients who belongs to the VR- group, the procedure was performed under standard conditions with a drape separating the patient from the operating site During surgery, the vital signs: HR, PANI, SpO2 were collected at the different peri-operative moments respectively at the entrance to the operating room (T0), 15 minutes after ALR (T1), 30 minutes after ALR (T2), 30 minutes (T3), 1 hour (T4) and 2 hours (T5) An intraoperative assessment of anxiety was performed after 15 minutes of ALR, i.e. at T1 by the LIKERT scale The anesthesist could administer anxiolytics outside of the contraindications. The molecule of choice is Midazolam and the dose taken is noted on the data collection form The administration of anxiolytics (Midazolam) is judged by clinical criteria determined in the protocol:- Anxiety during the operation judged as painful or important (higher than2 on the LIKERT scale) The session can be interrupted during the procedure for medical reasons or at the patient's request.If the local anesthesia fails and the patient is converted to general anesthesia, the protocol is cancelled and a standard induction is performed by the anesthesiologist.The events of desaturation (SpO2 < 90%), apnea, administration of anxiolytics administration of anxiolytics (to reach a minimal level of anxiety) were indicated on the data collection form.For both RV+ and RV- groups, postoperative anxiety was assessed using the scores:1- Postoperative STAI at H1 postoperative2- patient satisfaction evaluated by a LIKERT scale
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 2 arms are involved in the study . first arm will receive local anesthesia with virtual reality during the surgery to reduce patient's anxiety . second arm will receive standards care under regional anesthesia
| Arm | Type | Receives |
|---|---|---|
| group of patients who underwent surgery with the virtual reality experience | Active comparator | Device: a virtual reality devicepatients underwent surgery wearing a virtual reality mask |
| patients who underwent surgery in standard conditions without the virtual reality experience | No intervention | –patients underwent surgery without a virtual reality mask |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patient classified ASA 1 , 2 or 3
- patients undergoing an upper-limb surgery under regional anesthesia
Key exclusion criteria (3 listed)
- regional anesthesia failure
- local anesthetics intoxications
- symptoms of cyber-sickness
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 |
|---|---|---|
| a virtual reality devicethe patient will wear a masque tht will provide a virtual reality experience using a VR Gear connected to a mobile phone through an application installed on the mobile phone | Device | group of patients who underwent surgery with the virtual reality experience |
Primary outcome
hypnovel consumption during surgery
Time frame: From enrollment to the end of treatment at 10 weeks
the required dose of Midazolam for a LIKERT intraoperative anxiety score goal < 2
9 secondary outcomes
satisfaction level during surgery
Time frame: at the end of the procedure
pre-operative patients's anxiety level by LIKERT score
Time frame: From enrollment to the end of treatment at 10 weeks
per-operative patients's anxiety level by LIKERT score
Time frame: From enrollment to the end of treatment at 10 weeks
post-operative patients's anxiety level by LIKERT score
Time frame: From enrollment to the end of treatment at 10 weeks
vitals : systolic pressure
Time frame: From enrollment to the end of treatment at 10 weeks
vitals : heart rate
Time frame: From enrollment to the end of treatment at 10 weeks
vitals : oxygen saturation
Time frame: From enrollment to the end of treatment at 10 weeks
pre-operative patients's anxiety level by STAI-6 score
Time frame: From enrollment to the end of treatment at 10 weeks
post-operative patients's anxiety level by STAI-6 score
Time frame: From enrollment to the end of treatment at 10 weeks
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 29 Sep 2023.
- 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.
Majdoub Ali MD, professor principal investigator
University Hospital, Mahdia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing a virtual reality device in people with Anxiety and Satisfaction, Patient, run by University Hospital, Mahdia at 1 site in Tunisia.
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 2 inclusion and 3 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 29 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 Tunisia. 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?
hypnovel consumption during surgery (time frame: From enrollment to the end of treatment at 10 weeks). 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 29 Sep 2023.