Perioperative AnxietyVRNCT07132216
Effect of Virtual Reality on Anxiety, Stress, and Patient's Satisfaction Among Patients Undergoing Regional Anesthesia
A study testing Meta Quest 2 VR headset in people with Perioperative Anxiety and Perioperative Stress, run by Cairo University at 1 site in Palestinian Territories.
Trial summary
The goal of this clinical trial was to investigate the effect of Virtual Reality (VR) on intraoperative anxiety, stress, and patient satisfaction among Palestinian patients undergoing regional anesthesia. The study aimed to determine the efficacy and safety of VR as a non-pharmacological intervention during surgery. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Perioperative Anxiety, Perioperative Stress, Patient Satisfaction
- What is being tested?
- Meta Quest 2 VR headset
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 sitePalestinian Territories
- Study dates
- 17 Jul 2024to 12 Oct 2024
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who underwent elective urological surgery under regional anesthesia
- Patients older than 18 years
- Patients with no history of previous surgeries
- Patients suffering from moderate to severe anxiety and stress
Who cannot join
- Patients with a history of psychiatric disorders, epilepsy, hypertension, or chronic pain
- Patients who are mute and cannot read or write; patients with visual, hearing, or cognitive impairment
- Patients with implanted hearing aids or cardiac pacemakers
- Patients who received any anxiolytic, sedative, or hypnotic drugs before or during regional anesthesia
- Patients exposed to anesthetic or surgical complications during the operation
Trial locations and contacts
1 site in 1 country.
Palestinian Territories1 site
Rafidia Surgical Governmental Hospital, Nablus City, West Bank, Palestine
Nablus
About this study
Official title: Effect of Virtual Reality on Intraoperative Anxiety, Stress and Patient's Satisfaction Among Palestinian Patients Undergoing Regional Anesthesia
The goal of this clinical trial was to investigate the effect of Virtual Reality (VR) on intraoperative anxiety, stress, and patient satisfaction among Palestinian patients undergoing regional anesthesia. The study aimed to determine the efficacy and safety of VR as a non-pharmacological intervention during surgery. The main research hypotheses are:
H0: There will be no significant difference in anxiety levels between patients who receive immersive VR during regional anesthesia and those who do not receive pre- and post-virtual reality therapy.
Read more
H0: There will be no significant difference in perceived stress levels between patients who receive immersive VR during regional anesthesia and those who do not receive pre- and post-virtual reality therapy.
H0: There will be no significant difference in satisfaction levels between patients who receive immersive VR during regional anesthesia and those who do not receive pre- and post-virtual reality therapy.
Participants will:
Receive either VR intervention or standard care during their surgery. Complete assessments of anxiety and stress before and after the procedure using validated scales.
Provide feedback on their satisfaction levels post-operation using a Visual Analog Scale.
Be monitored for hemodynamic parameters throughout the surgical process.
Read the detailed description
Title: Effect of Virtual Reality on Intraoperative Anxiety, Stress, and Patient Satisfaction among Palestinian Patients Undergoing Regional Anesthesia
Background: Preoperative and intraoperative anxiety and stress are common psychological responses that negatively impact surgical outcomes and patient satisfaction. While pharmacological interventions are traditionally used to manage these responses, non-pharmacological methods such as virtual reality (VR) are gaining prominence. This study aimed to evaluate the effect of VR on intraoperative anxiety, stress, and patient satisfaction among Palestinian patients undergoing regional anesthesia.
Methods: A randomized controlled trial was conducted at Rafidia Governmental Surgical Hospital in Nablus, Palestine, from June to September 2024. A total of 150 patients scheduled for elective urological surgery under regional anesthesia were randomly assigned into VR (n=75) and control (n=75) groups. Participants in the VR group received immersive VR intervention during the operation using head-mounted devices, while the control group received routine care. Anxiety was assessed using the State-Trait Anxiety Inventory (STAI), stress using the Perceived Stress Scale (PSS-10), and patient satisfaction using the Visual Analog Scale (VAS). Hemodynamic parameters were also monitored.
- Conditions
- Perioperative Anxiety, Perioperative Stress, Patient Satisfaction, Regional Anesthesia, Elective Surgery
- Being tested
- Meta Quest 2 VR headset
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meta Quest 2 VR headsetDevice
The Meta Quest 2 VR headset with built-in headphones was used. Patients selected VR environments from a predefined list of five nature scenes (beach, forest, mountain, underwater, and meadow) with identical meditation audio tracks lasting 30 minutes each. Guided Meditation VR from Cubicle Ninjas (https://guidedmeditationvr.com/)featured 360-degree nature environments with standardized calming background music and guided meditation narration. VR was applied immediately after spinal anesthesia and before the surgical incision. Sessions lasted 30 minutes and were discontinued if the patient reported nausea, dizziness, or requested removal.
| Study group | Role | What they receive |
|---|---|---|
| VR group | Experimental | The Meta Quest 2 VR headset with built-in headphones was used. Patients selected VR environments from a predefined list of five nature scenes (beach, forest, mountain, underwater, and meadow) with identical meditation audio tracks lasting 30 minutes each. Guided Meditation VR from Cubicle Ninjas (https://guidedmeditationvr.com/)featured 360-degree nature environments with standardized calming background music and guided meditation narration. VR was applied immediately after spinal anesthesia and before the surgical incision. Sessions lasted 30 minutes and were discontinued if the patient reported nausea, dizziness, or requested removal. Receives: Device: Meta Quest 2 VR headset |
| control group | No intervention | Participants in the control group only receive standard care according to the hospital's protocol during the operation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The State-Trait Anxiety Inventory (STAI)
The STAI score ranges between 20-80, the higher score indicating greater anxiety. It is classified as "no or low anxiety" (20-37), "moderate anxiety" (38-44), and "high anxiety" (45-80).
Measured: preoperative and then 60 minutes postoperatively
Perceived Stress Scale (PSS-10)
The PSS-10 score can range from 0 to 40 with higher scores indicating higher perceived stress. It is classified as "no or low anxiety" (0-13), "moderate anxiety" (14-26), and "high anxiety" (27-40).
Measured: preoperative and 60 minutes postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2025
- Study start17 Jul 2024
- Primary completion12 Sep 2024
- Study completion12 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Perioperative AnxietyStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Participants in the VR group received immersive VR intervention during the operation using head-mounted devices, while the control group received routine care. The Meta Quest 2 VR headset with built-in headphones was used. Patients selected VR environments from a predefined list of five nature scenes (beach, forest, mountain, underwater, and meadow) with identical meditation audio tracks lasting 30 minutes each. Guided Meditation VR from Cubicle Ninjas featured 360-degree nature environments with standardized calming background music and guided meditation narration. VR was applied immediately after spinal anesthesia before the surgical incision. Sessions lasted 30 minutes and were discontinued if the patient reported nausea, dizziness, or requested removal.
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, khulud "Mohammad Hasham" Hasham Mansor, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07132216
- Sponsor's protocol ID
- IRB RHDIRB2019041701
- Acronym
- VR
- Status last verified
- Aug 2025
- First submitted
- 12 Aug 2025
- Last updated
- 20 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This research was conducted to achieve a PhD degree.The paper is currently under review for publication, and sharing it before the review process is complete could violate journal policies.
Publications
Mansor K, Abdellatif SA, Mohamed NA. Virtual Reality as an Intervention for Intraoperative Anxiety and Stress in Regional Anesthesia: A Randomized Controlled Trial. Health Sci Rep. 2026 Mar 15;9(3):e72113. doi: 10.1002/hsr2.72113. eCollection 2026 Mar.
PubMed 42022663Mansor K, Abdellatif SA, Mohamed NA. Virtual reality for reducing intraoperative anxiety and improving patient satisfaction under regional anesthesia among palestinian patients: a randomized controlled trial. BMC Anesthesiol. 2025 Nov 27;25(1):593. doi: 10.1186/s12871-025-03475-3.
PubMed 41310456
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Virtual Reality on Intraoperative Anxiety, Stress and Patient's Satisfaction Among Palestinian Patients Undergoing Regional Anesthesia
- ClinicalTrials.gov ID
- NCT07132216
- Acronym / sponsor ID
- VR / IRB RHDIRB2019041701
- Conditions
- Perioperative Anxiety, Perioperative Stress, Patient Satisfaction, Regional Anesthesia, Elective Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 17 Jul 2024 (actual)
- Primary completion
- 12 Sep 2024 (actual)
- Study completion
- 12 Oct 2024 (actual)
- First posted
- 20 Aug 2025 (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 goal of this clinical trial was to investigate the effect of Virtual Reality (VR) on intraoperative anxiety, stress, and patient satisfaction among Palestinian patients undergoing regional anesthesia. The study aimed to determine the efficacy and safety of VR as a non-pharmacological intervention during surgery. The main research hypotheses are:
H0: There will be no significant difference in anxiety levels between patients who receive immersive VR during regional anesthesia and those who do not receive pre- and post-virtual reality therapy.
H0: There will be no significant difference in perceived stress levels between patients who receive immersive VR during regional anesthesia and those who do not receive pre- and post-virtual reality therapy.
H0: There will be no significant difference in satisfaction levels between patients who receive immersive VR during regional anesthesia and those who do not receive pre- and post-virtual reality therapy.
Participants will:
Receive either VR intervention or standard care during their surgery. Complete assessments of anxiety and stress before and after the procedure using validated scales.
Provide feedback on their satisfaction levels post-operation using a Visual Analog Scale.
Be monitored for hemodynamic parameters throughout the surgical process.
Detailed description
Title: Effect of Virtual Reality on Intraoperative Anxiety, Stress, and Patient Satisfaction among Palestinian Patients Undergoing Regional Anesthesia
Background: Preoperative and intraoperative anxiety and stress are common psychological responses that negatively impact surgical outcomes and patient satisfaction. While pharmacological interventions are traditionally used to manage these responses, non-pharmacological methods such as virtual reality (VR) are gaining prominence. This study aimed to evaluate the effect of VR on intraoperative anxiety, stress, and patient satisfaction among Palestinian patients undergoing regional anesthesia.
Methods: A randomized controlled trial was conducted at Rafidia Governmental Surgical Hospital in Nablus, Palestine, from June to September 2024. A total of 150 patients scheduled for elective urological surgery under regional anesthesia were randomly assigned into VR (n=75) and control (n=75) groups. Participants in the VR group received immersive VR intervention during the operation using head-mounted devices, while the control group received routine care. Anxiety was assessed using the State-Trait Anxiety Inventory (STAI), stress using the Perceived Stress Scale (PSS-10), and patient satisfaction using the Visual Analog Scale (VAS). Hemodynamic parameters were also monitored.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants in the VR group received immersive VR intervention during the operation using head-mounted devices, while the control group received routine care. The Meta Quest 2 VR headset with built-in headphones was used. Patients selected VR environments from a predefined list of five nature scenes (beach, forest, mountain, underwater, and meadow) with identical meditation audio tracks lasting 30 minutes each. Guided Meditation VR from Cubicle Ninjas featured 360-degree nature environments with standardized calming background music and guided meditation narration. VR was applied immediately after spinal anesthesia before the surgical incision. Sessions lasted 30 minutes and were discontinued if the patient reported nausea, dizziness, or requested removal.
| Arm | Type | Receives |
|---|---|---|
| VR group | Experimental | Device: Meta Quest 2 VR headsetThe Meta Quest 2 VR headset with built-in headphones was used. Patients selected VR environments from a predefined list of five nature scenes (beach, forest, mountain, underwater, and meadow) with identical meditation audio tracks lasting 30 minutes each. Guided Meditation VR from Cubicle Ninjas (https://guidedmeditationvr.com/)featured 360-degree nature environments with standardized calming background music and guided meditation narration. VR was applied immediately after spinal anesthesia and before the surgical incision. Sessions lasted 30 minutes and were discontinued if the patient reported nausea, dizziness, or requested removal. |
| control group | No intervention | –Participants in the control group only receive standard care according to the hospital's protocol during the operation. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients who underwent elective urological surgery under regional anesthesia
- Patients older than 18 years
- Patients with no history of previous surgeries
- Patients suffering from moderate to severe anxiety and stress
Key exclusion criteria (5 listed)
- Patients with a history of psychiatric disorders, epilepsy, hypertension, or chronic pain
- Patients who are mute and cannot read or write; patients with visual, hearing, or cognitive impairment
- Patients with implanted hearing aids or cardiac pacemakers
- Patients who received any anxiolytic, sedative, or hypnotic drugs before or during regional anesthesia
- Patients exposed to anesthetic or surgical complications during the operation
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 |
|---|---|---|
| Meta Quest 2 VR headsetThe Meta Quest 2 VR headset with built-in headphones was used. Patients selected VR environments from a predefined list of five nature scenes (beach, forest, mountain, underwater, and meadow) with identical meditation audio tracks lasting 30 minutes each. Guided Meditation VR from Cubicle Ninjas (https://guidedmeditationvr.com/)featured 360-degree nature environments with standardized calming background music and guided meditation narration. VR was applied immediately after spinal anesthesia and before the surgical incision. Sessions lasted 30 minutes and were discontinued if the patient reported nausea, dizziness, or requested removal. | Device | VR group |
Primary outcome
The State-Trait Anxiety Inventory (STAI)
Time frame: preoperative and then 60 minutes postoperatively
The STAI score ranges between 20-80, the higher score indicating greater anxiety. It is classified as "no or low anxiety" (20-37), "moderate anxiety" (38-44), and "high anxiety" (45-80).
Perceived Stress Scale (PSS-10)
Time frame: preoperative and 60 minutes postoperatively
The PSS-10 score can range from 0 to 40 with higher scores indicating higher perceived stress. It is classified as "no or low anxiety" (0-13), "moderate anxiety" (14-26), and "high anxiety" (27-40).
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 20 Aug 2025.
- Derived from this study: PubMed 42022663Mansor K, Abdellatif SA, Mohamed NA. Virtual Reality as an Intervention for Intraoperative Anxiety and Stress in Regional Anesthesia: A Randomized Controlled Trial. Health Sci Rep. 2026 Mar 15;9(3):e72113. doi: 10.1002/hsr2.72113. eCollection 2026 Mar.
- Derived from this study: PubMed 41310456Mansor K, Abdellatif SA, Mohamed NA. Virtual reality for reducing intraoperative anxiety and improving patient satisfaction under regional anesthesia among palestinian patients: a randomized controlled trial. BMC Anesthesiol. 2025 Nov 27;25(1):593. doi: 10.1186/s12871-025-03475-3.
- the website Guided Meditation VR application, developed by Cubicle Ninjas AgencyLink provided by the sponsor.
- Individual participant dataSharing planned: No. This research was conducted to achieve a PhD degree.The paper is currently under review for publication, and sharing it before the review process is complete could violate journal policies.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Meta Quest 2 VR headset in people with Perioperative Anxiety and Perioperative Stress, run by Cairo University at 1 site in Palestinian Territories.
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 4 inclusion and 5 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 20 Aug 2025. 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 Palestinian Territories. 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?
The State-Trait Anxiety Inventory (STAI) (time frame: preoperative and then 60 minutes postoperatively). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07132216, which also lists 2 linked publications.
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 20 Aug 2025.