Virtual reality versus IV dexmedetomidine to reduce maternal anxiety during cesarean delivery
Effect of Virtual Reality Versus Intravenous Dexmedetomidine on Maternal Anxiety, Stress, Hemodynamics, and Neonatal Outcomes During Cesarean Section
This study will test whether virtual reality or an IV dexmedetomidine infusion better reduces anxiety, stabilizes blood pressure and heart rate, and improves newborn breathing and heart rate in women having elective cesarean delivery under neuraxial anesthesia.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 52 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Benha University Academic / other |
| Locations | 1 site (Banhā, Benha) |
| Trial ID | NCT07343843 on ClinicalTrials.gov |
What this trial studies
Women scheduled for elective cesarean delivery under central neuraxial blockade will receive either an intravenous dexmedetomidine infusion or an immersive virtual reality session during the procedure. The trial compares effects on maternal anxiety and stress, perioperative hemodynamic stability (blood pressure and heart rate), and immediate neonatal outcomes such as respiration and heart rate. Key exclusions include psychiatric disorders, sensory impairments, epilepsy, claustrophobia, active labor, fetal distress, and contraindications to regional anesthesia. Outcomes are measured during the perioperative period and in the immediate newborn assessment.
Who should consider this trial
Good fit: Adult women (≥18 years) with ASA physical status II who are scheduled for elective cesarean under central neuraxial blockade and can provide informed consent, without psychiatric, sensory, neurologic, or pregnancy-related complications, are ideal candidates.
Not a fit: Patients with contraindications to regional anesthesia, sensory impairments (blindness or deafness), epilepsy, claustrophobia, active labor, fetal distress, or pregnancy-related complications are unlikely to be eligible or to receive benefit from the interventions.
Why it matters
Potential benefit: If successful, the interventions could reduce maternal anxiety, improve hemodynamic stability during cesarean delivery, and potentially lead to better immediate newborn respiratory and heart rate outcomes.
How similar studies have performed: Previous studies have reported that dexmedetomidine reduces perioperative anxiety and that VR can lower procedural anxiety in other surgical settings, but direct comparisons in cesarean delivery remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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 * Patients with suspected eye infection * Signs of active labor. * Pregnancy related-diseases or antepartum hemorrhage. * Presence of Fetal distress.
Where this trial is running
Banhā, Benha
- Benha University — Banhā, Benha, Egypt (Recruiting)
Study contacts
- Study coordinator: Emad M Sayed, MBBCH
- Email: dr.emad.mohamedsayed@gmail.com
- Phone: 00201111710428
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.