Virtual RealityNCT07343843
Virtual Reality Versus Intravenous Dexmedetomidine on Maternal Anxiety, Stress, Hemodynamics, and Neonatal Outcomes During Cesarean Section
A study testing Dexmedetomidine and Virtual reality in people with Virtual Reality and Dexmedetomidine, run by Benha University at 1 site in Egypt.
Trial summary
This study aims to compare the efficacy of intravenous dexmedetomidine infusion versus virtual reality (VR) in reducing maternal anxiety, stress, and hemodynamic instability during cesarean section and their effects on neonatal outcome as respiration and heart rate. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Virtual Reality, Dexmedetomidine, Maternal Anxiety
- What is being tested?
- Dexmedetomidine and Virtual reality
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteEgypt
- Study dates
- 17 Jan 2026to 1 Jul 2026
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age over 18 years old.
- American Society of Anesthesiologists (ASA) physical status II.
- Scheduled for elective cesarean section (CS) delivery under Central Neuraxial Blockade.
- Provide informed consent and agree to participate in the study.
Who cannot join
- Patient's refusal
- Patient known have contraindications for Regional Anesthesia as infection at the site of injection, severe coagulopathy or allergy to local anesthetics.
- Patient with psychiatric disorders.
- Sensory impairment (blindness, deafness).
- Any technical problem preventing proper fitting of the glasses to the patient face.
- Patients with cognitive impairment, epilepsy or with claustrophobia
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- Patients with suspected eye infection
- Signs of active labor.
- Pregnancy related-diseases or antepartum hemorrhage.
- Presence of Fetal distress.
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
Benha University
Banhā, Benha, 13518
Emad M Sayed, MBBCH, 00201111710428, dr.emad.mohamedsayed@gmail.com
Saad I Saad, MD
About this study
Official title: Effect of Virtual Reality Versus Intravenous Dexmedetomidine on Maternal Anxiety, Stress, Hemodynamics, and Neonatal Outcomes During Cesarean Section
This study aims to compare the efficacy of intravenous dexmedetomidine infusion versus virtual reality (VR) in reducing maternal anxiety, stress, and hemodynamic instability during cesarean section and their effects on neonatal outcome as respiration and heart rate.
Read the detailed description
Cesarean section (CS) is one of the most frequently performed surgical procedures worldwide, with steadily increasing rates across both developed and developing countries.
Dexmedetomidine, a highly selective α₂-adrenergic receptor agonist, has been increasingly utilized in obstetric anesthesia because of its anxiolytic, sedative, and analgesic properties with minimal respiratory depression.
Non-pharmacological interventions, such as virtual reality (VR), have emerged as innovative strategies for perioperative anxiety management. VR provides immersive distraction, thereby modulating pain perception and reducing stress.
- Conditions
- Virtual Reality, Dexmedetomidine, Maternal Anxiety, Stress, Hemodynamics, Neonatal Outcomes
- Being tested
- Dexmedetomidine, Virtual reality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Following confirmation of adequate spinal anesthesia, dexmedetomidine will be administered as an intravenous infusion of 0.2-0.4µg/kg/hr until abdominal closure.
Virtual realityOther
Participants will be fitted with virtual reality headsets immediately after the establishment of spinal anesthesia. The headsets will display calming immersive audiovisual content, and participants will continue wearing them throughout the entire procedure until skin closure.
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine group | Experimental | Following confirmation of adequate spinal anesthesia, dexmedetomidine will be administered as an intravenous infusion of 0.2-0.4µg/kg/hr until abdominal closure. Receives: Drug: Dexmedetomidine |
| Virtual reality group | Experimental | Participants will be fitted with virtual reality headsets immediately after the establishment of spinal anesthesia. The headsets will display calming immersive audiovisual content, and participants will continue wearing them throughout the entire procedure until skin closure. Receives: Other: Virtual reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal anxiety
Maternal anxiety will be assessed at three time points (On admission to the operating theatre, At skin suturing, Two hours postoperatively in the recovery room) using the Novel Visual Facial Anxiety Scale (NVFAS), a validated pictorial self-report measure.
NVFAS will be applied to measure acute state anxiety. This self-reported pictorial tool consists of 11 facial expressions corresponding to anxiety scores from 0 (no anxiety) to 10 (severe anxiety). The scale is user-friendly, language-independent, and has been validated for perioperative patients, including those with limited time for traditional questionnaires.
Measured: Two hours postoperatively in the recovery room
Secondary outcomes (6)
Heart rate
Heart rate will be recorded at six predefined intra- and postoperative intervals.
Measured: 24 hours postoperatively
Mean arterial pressure
Mean arterial pressure will be recorded at six predefined intra- and postoperative intervals.
Measured: 24 hours postoperatively
Peripheral Oxygen Saturation
Peripheral Oxygen Saturation will be recorded at six predefined intra- and postoperative intervals.
Measured: 24 hours postoperatively
Stress Level
Stress Levels will be measured using the Brief Measure of Emotional Preoperative Stress (B-MEPS) on admission to the operating theatre, at skin suturing, and two hours postoperatively in the recovery room.
The B-MEPS will be used to assess maternal stress levels. This 12-item tool will be designed as a shorter version of the full Emotional Preoperative Stress scale. It includes items rated on 2-point, 3- point, and 4-point Likert scales, with higher total scores (range 12-36) indicating greater preoperative stress.
Measured: Two hours postoperatively in the recovery room
Maternal Satisfaction
Maternal satisfaction will be evaluated using the Birth Satisfaction Scale-Revised (BSS-R), a widely used and validated instrument in obstetric research. The BSSR comprises 10 items rated on a 5-point Likert scale, ranging from "strongly disagree" [1] to "strongly agree" [5]. Scores will categorize participants into: completely unsatisfied (10-18), unsatisfied (19-26), neutral (27-34), satisfied (35-42), or completely satisfied (43-50).
Measured: Two hours postoperatively in the recovery room
Apgar score
Apgar scores will be recorded at 1 and 5 minutes.
Measured: 5 minutes postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study start17 Jan 2026
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
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.
- More trials run by Benha 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emad Mohamed Sayed, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07343843
- Sponsor's protocol ID
- MS.29.12.2025
- Status last verified
- Jan 2026
- First submitted
- 7 Jan 2026
- Last updated
- 21 Jan 2026
- 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 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Virtual Reality Versus Intravenous Dexmedetomidine on Maternal Anxiety, Stress, Hemodynamics, and Neonatal Outcomes During Cesarean Section
- ClinicalTrials.gov ID
- NCT07343843
- Acronym / sponsor ID
- MS.29.12.2025
- Conditions
- Virtual Reality, Dexmedetomidine, Maternal Anxiety, Stress, Hemodynamics, Neonatal Outcomes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 17 Jan 2026 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 15 Jan 2026 (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 aims to compare the efficacy of intravenous dexmedetomidine infusion versus virtual reality (VR) in reducing maternal anxiety, stress, and hemodynamic instability during cesarean section and their effects on neonatal outcome as respiration and heart rate.
Detailed description
Cesarean section (CS) is one of the most frequently performed surgical procedures worldwide, with steadily increasing rates across both developed and developing countries.
Dexmedetomidine, a highly selective α₂-adrenergic receptor agonist, has been increasingly utilized in obstetric anesthesia because of its anxiolytic, sedative, and analgesic properties with minimal respiratory depression.
Non-pharmacological interventions, such as virtual reality (VR), have emerged as innovative strategies for perioperative anxiety management. VR provides immersive distraction, thereby modulating pain perception and reducing stress.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine group | Experimental | Drug: DexmedetomidineFollowing confirmation of adequate spinal anesthesia, dexmedetomidine will be administered as an intravenous infusion of 0.2-0.4µg/kg/hr until abdominal closure. |
| Virtual reality group | Experimental | Other: Virtual realityParticipants will be fitted with virtual reality headsets immediately after the establishment of spinal anesthesia. The headsets will display calming immersive audiovisual content, and participants will continue wearing them throughout the entire procedure until skin closure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age over 18 years old.
- American Society of Anesthesiologists (ASA) physical status II.
- Scheduled for elective cesarean section (CS) delivery under Central Neuraxial Blockade.
- Provide informed consent and agree to participate in the study.
Key exclusion criteria (10 listed)
- Patient's refusal
- Patient known have contraindications for Regional Anesthesia as infection at the site of injection, severe coagulopathy or allergy to local anesthetics.
- Patient with psychiatric disorders.
- Sensory impairment (blindness, deafness).
- Any technical problem preventing proper fitting of the glasses to the patient face.
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 |
|---|---|---|
| DexmedetomidineFollowing confirmation of adequate spinal anesthesia, dexmedetomidine will be administered as an intravenous infusion of 0.2-0.4µg/kg/hr until abdominal closure. | Drug | Dexmedetomidine group |
| Virtual realityParticipants will be fitted with virtual reality headsets immediately after the establishment of spinal anesthesia. The headsets will display calming immersive audiovisual content, and participants will continue wearing them throughout the entire procedure until skin closure. | Other | Virtual reality group |
Primary outcome
Maternal anxiety
Time frame: Two hours postoperatively in the recovery room
Maternal anxiety will be assessed at three time points (On admission to the operating theatre, At skin suturing, Two hours postoperatively in the recovery room) using the Novel Visual Facial Anxiety Scale (NVFAS), a validated pictorial self-report measure. NVFAS will be applied to measure acute state anxiety. This self-reported pictorial tool consists of 11 facial expressions corresponding to anxiety scores from 0 (no anxiety) to 10 (severe anxiety). The scale is user-friendly, language-independent, and has been validated for perioperative patients, including those with limited time for traditional questionnaires.
6 secondary outcomes
Heart rate
Time frame: 24 hours postoperatively
Mean arterial pressure
Time frame: 24 hours postoperatively
Peripheral Oxygen Saturation
Time frame: 24 hours postoperatively
Stress Level
Time frame: Two hours postoperatively in the recovery room
Maternal Satisfaction
Time frame: Two hours postoperatively in the recovery room
Apgar score
Time frame: 5 minutes postoperatively
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 21 Jan 2026.
- 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 Dexmedetomidine and Virtual reality in people with Virtual Reality and Dexmedetomidine, run by Benha 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 21 Jan 2026. 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 Emad M Sayed, MBBCH (00201111710428, dr.emad.mohamedsayed@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maternal anxiety (time frame: Two hours postoperatively in the recovery room). 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 21 Jan 2026.