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Clinical Trials in Egypt / NCT07343843
Recruiting Not applicable

Virtual Reality Versus Intravenous Dexmedetomidine on Maternal Anxiety, Stress, Hemodynamics, and Neonatal Outcomes During Cesarean Section

NCT07343843 · tracked via the Priya Life Science Egypt tracker
Sponsor
Benha University
Phase
Not applicable
Started
2026-01-17
Last updated
2026-01-21

Condition(s) studied

Virtual RealityDexmedetomidineMaternal AnxietyStressHemodynamicsNeonatal OutcomesCesarean Section

Investigational drug(s) / intervention(s)

Dexmedetomidine →Virtual reality

Dexmedetomidine: 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 reality: 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 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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Maternal anxiety — 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.

Trial sites (1)

FacilityCityRegionStatus
Benha University Banhā Benha Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07343843 on ClinicalTrials.gov ↗ ← All trials in Egypt