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Recruiting NCT07343843

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

No phase Interventional Virtual Reality Dexmedetomidine Maternal Anxiety Stress

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Dexmedetomidine, Virtual reality.
Who it may be relevant to
Registry conditions: Virtual Reality, Dexmedetomidine, Maternal Anxiety, Stress. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Drug 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.
  • Other 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.

Primary outcome measures

  • Maternal anxiety [Time frame: Two hours postoperatively in the recovery room]
Secondary outcome measures (6)
  • 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]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Benha University — Banhā

Identifiers

NCT: NCT07343843 · MS.29.12.2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗