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

B

Benha University

Status

Enrolling

Conditions

Maternal Anxiety
Cesarean Section
Dexmedetomidine
Neonatal Outcomes
Virtual Reality
Hemodynamics
Stress

Treatments

Other: Virtual reality
Drug: Dexmedetomidine

Study type

Interventional

Funder types

Other

Identifiers

NCT07343843
MS.29.12.2025

Details and patient eligibility

About

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.

Full 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.

Enrollment

52 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

52 participants in 2 patient groups

Dexmedetomidine group
Experimental group
Description:
Following confirmation of adequate spinal anesthesia, dexmedetomidine will be administered as an intravenous infusion of 0.2-0.4µg/kg/hr until abdominal closure.
Treatment:
Drug: Dexmedetomidine
Virtual reality group
Experimental group
Description:
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.
Treatment:
Other: Virtual reality

Trial contacts and locations

1

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Central trial contact

Emad M Sayed, MBBCH

Data sourced from clinicaltrials.gov

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