Anxiolytic EffectNCT07050095
Anxiolytic Effect of Virtual Reality Immersion Versus Midazolam Premedication in Patients Undergoing Dacryocystorhinostomy Surgery
A study testing Virtual Reality Group and Midazolam Group in people with Anxiolytic Effect and Virtual Reality Immersion, run by Cairo University at 1 site in Egypt.
Trial summary
The aim is to investigate the anxiolytic effect, and hemodynamic stability of using virtual reality immersion in adult patients undergoing Dacryocystorhinostomy (DCR) operation under general anesthesia and to compare its effect to that of using Midazolam as a premedication. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anxiolytic Effect, Virtual Reality Immersion, Midazolam
- What is being tested?
- Virtual Reality Group and Midazolam Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2025to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-65.
- Both sexes.
- American Society of Anesthesiologists (ASA) classification: I - II.
- Patient undergoing Dacryocystorhinostomy Surgery (DCR) operation under general anesthesia.
Who cannot join
- Patient refusal.
- Patients with cardiac diseases.
- Patients with renal diseases.
- Patients with drug sensitivity and seizures.
- Substance abuse and addiction.
- Claustrophobia.
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- Patients with cerebrovascular disease.
- Psychiatric and cognitive disorder.
- Patients with severe teary eyes and blurring of vision.
- Patients who express discomfort during the test.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Cairo University
Cairo, 12613
Hebatullah S Abdelhamid, MD, 002 01044512277, drhebasalah593@gmail.com
Tamer F Safan, MD
About this study
Official title: Randomized Clinical Trial for Comparison Between the Anxiolytic Effect of Virtual Reality Immersion Versus Midazolam Premedication in Patients Undergoing Dacryocystorhinostomy Surgery
The aim is to investigate the anxiolytic effect, and hemodynamic stability of using virtual reality immersion in adult patients undergoing Dacryocystorhinostomy (DCR) operation under general anesthesia and to compare its effect to that of using Midazolam as a premedication.
Read the detailed description
Anxiety is a negative emotion characterized by fear, tension, and nervousness. Preoperative anxiety is anxiety due to disease, hospitalization, or scheduled surgery. The most common causes of preoperative anxiety are waiting for surgery, worrying about the operation outcome, being separated from family, anticipating postoperative pain, losing independence, and being afraid of surgery, pain, and death.
Midazolam reduces anxiety by acting on GABAA receptors, resulting in sedation; however, the benefit of midazolam premedication remains debatable, and the drug's side effects include paradoxical reactions, oversedation, reduced blood pressure, and respiratory depression. Regarding this, some clinicians challenge the clinical benefits of benzodiazepine premedication and contend that non-pharmacological treatments alone are sufficient to minimize preoperative anxiety.
Virtual reality is a computer technology that creates the sensation of being immersed in a simulated three-dimensional environment in which the user can interact with the virtual environment. It has also been suggested as a non-pharmaceutical alternative for lowering surgical pain and anxiety.
Dacryocystorhinostomy (DCR) is a procedure that circumvents the blocked tear duct and offers an alternate path for the drainage of tears from the eye to the nose and is most effectively performed under a general anesthetic.
- Conditions
- Anxiolytic Effect, Virtual Reality Immersion, Midazolam, Premedication, Dacryocystorhinostomy
- Being tested
- Virtual Reality Group, Midazolam Group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality GroupOther
Also called Guided Meditation VR
Patient will undergo virtual reality (VR) immersion using oculus.
Midazolam GroupDrug
Also called Midazolam
Patient will receive midazolam premedication only.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Group | Experimental | Patient will undergo virtual reality (VR) immersion using oculus. Receives: Other: Virtual Reality Group |
| Midazolam Group | Active comparator | Patient will receive midazolam premedication only. Receives: Drug: Midazolam Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety Score
Beck Anxiety Inventory (BAI) score change measured from pre- to post-intervention (virtual reality (VR) or midazolam). The score ranges from 0 to 63. A greater reduction indicates better anxiolytic effect.5 minutes before intervention and Immediately after the 15-minute virtual reality (VR) session or midazolam injection
Measured: 15-minute after intervention
Secondary outcomes (6)
Heart rate (HR)
Heart rate (HR) measured to assess perioperative hemodynamic response to anxiolytic intervention.At four time points: T1 (initial on the day of surgery), T2 (before induction), T3 (before intubation), and T4 (after intubation).
Measured: After intubation (Up to 2 hours)
Systolic blood pressure (SBP)
Systolic blood pressure (SBP) recorded to evaluate cardiovascular response to premedication and induction.At four time points: T1 (initial on the day of surgery), T2 (before induction), T3 (before intubation), and T4 (after intubation).
Measured: After intubation (Up to 2 hours)
Diastolic blood pressure (DBP)
Diastolic blood pressure (DBP) measured to monitor hemodynamic changes related to stress and sedation.At four time points: T1 (initial on the day of surgery), T2 (before induction), T3 (before intubation), and T4 (after intubation).
Measured: After intubation (Up to 2 hours)
Mean blood pressure (MBP)
Mean blood pressure (MBP) recorded to reflect overall perfusion pressure during perioperative period.At four time points: T1 (initial on the day of surgery), T2 (before induction), T3 (before intubation), and T4 (after intubation).
Measured: After intubation (Up to 2 hours)
Patient Satisfaction
Survey with options: very satisfied, satisfied, undecided, or unsatisfied
Measured: 2 hours Post intervention
Incidence of Complications
Presence of headache, dizziness, nausea, or virtual reality (VR)related discomfort.
Measured: First 30 minutes post-extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2025
- Study start1 Jun 2025
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiolytic EffectStudies 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
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hebatallah Salah Abdelhamid, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07050095
- Sponsor's protocol ID
- MS-526-2023
- Status last verified
- Jun 2025
- First submitted
- 25 Jun 2025
- Last updated
- 3 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial for Comparison Between the Anxiolytic Effect of Virtual Reality Immersion Versus Midazolam Premedication in Patients Undergoing Dacryocystorhinostomy Surgery
- ClinicalTrials.gov ID
- NCT07050095
- Acronym / sponsor ID
- MS-526-2023
- Conditions
- Anxiolytic Effect, Virtual Reality Immersion, Midazolam, Premedication, Dacryocystorhinostomy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 3 Jul 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 aim is to investigate the anxiolytic effect, and hemodynamic stability of using virtual reality immersion in adult patients undergoing Dacryocystorhinostomy (DCR) operation under general anesthesia and to compare its effect to that of using Midazolam as a premedication.
Detailed description
Anxiety is a negative emotion characterized by fear, tension, and nervousness. Preoperative anxiety is anxiety due to disease, hospitalization, or scheduled surgery. The most common causes of preoperative anxiety are waiting for surgery, worrying about the operation outcome, being separated from family, anticipating postoperative pain, losing independence, and being afraid of surgery, pain, and death.
Midazolam reduces anxiety by acting on GABAA receptors, resulting in sedation; however, the benefit of midazolam premedication remains debatable, and the drug's side effects include paradoxical reactions, oversedation, reduced blood pressure, and respiratory depression. Regarding this, some clinicians challenge the clinical benefits of benzodiazepine premedication and contend that non-pharmacological treatments alone are sufficient to minimize preoperative anxiety.
Virtual reality is a computer technology that creates the sensation of being immersed in a simulated three-dimensional environment in which the user can interact with the virtual environment. It has also been suggested as a non-pharmaceutical alternative for lowering surgical pain and anxiety.
Dacryocystorhinostomy (DCR) is a procedure that circumvents the blocked tear duct and offers an alternate path for the drainage of tears from the eye to the nose and is most effectively performed under a general anesthetic.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Group | Experimental | Other: Virtual Reality GroupPatient will undergo virtual reality (VR) immersion using oculus. |
| Midazolam Group | Active comparator | Drug: Midazolam GroupPatient will receive midazolam premedication only. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 18-65.
- Both sexes.
- American Society of Anesthesiologists (ASA) classification: I - II.
- Patient undergoing Dacryocystorhinostomy Surgery (DCR) operation under general anesthesia.
Key exclusion criteria (10 listed)
- Patient refusal.
- Patients with cardiac diseases.
- Patients with renal diseases.
- Patients with drug sensitivity and seizures.
- Substance abuse and addiction.
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 Reality GroupAlso: Guided Meditation VRPatient will undergo virtual reality (VR) immersion using oculus. | Other | Virtual Reality Group |
| Midazolam GroupAlso: MidazolamPatient will receive midazolam premedication only. | Drug | Midazolam Group |
Primary outcome
Anxiety Score
Time frame: 15-minute after intervention
Beck Anxiety Inventory (BAI) score change measured from pre- to post-intervention (virtual reality (VR) or midazolam). The score ranges from 0 to 63. A greater reduction indicates better anxiolytic effect.5 minutes before intervention and Immediately after the 15-minute virtual reality (VR) session or midazolam injection
6 secondary outcomes
Heart rate (HR)
Time frame: After intubation (Up to 2 hours)
Systolic blood pressure (SBP)
Time frame: After intubation (Up to 2 hours)
Diastolic blood pressure (DBP)
Time frame: After intubation (Up to 2 hours)
Mean blood pressure (MBP)
Time frame: After intubation (Up to 2 hours)
Patient Satisfaction
Time frame: 2 hours Post intervention
Incidence of Complications
Time frame: First 30 minutes post-extubation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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.
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 Group and Midazolam Group in people with Anxiolytic Effect and Virtual Reality Immersion, run by Cairo University at 1 site in Egypt.
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 10 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: looking for participants now, as of the sponsor's last update on 3 Jul 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 Egypt. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hebatullah S Abdelhamid, MD (002 01044512277, drhebasalah593@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety Score (time frame: 15-minute after 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 3 Jul 2025.