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

NCT07343843 | Recruiting

• 1 other identifier: MS.29.12.2025
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cesarean Section; Virtual Reality; Dexmedetomidine; Maternal Anxiety; Stress; Hemodynamics; Neonatal Outcomes

Outcome Measures

Primary Outcomes (1)

• 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.

  Two hours postoperatively in the recovery room

Secondary Outcomes (6)

• Heart rate

  24 hours postoperatively

• Mean arterial pressure

  24 hours postoperatively

• Peripheral Oxygen Saturation

  24 hours postoperatively

• Stress Level

  Two hours postoperatively in the recovery room

• Maternal Satisfaction

  Two hours postoperatively in the recovery room

Study Arms (2)

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.

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.

Other: Virtual reality

Interventions

Dexmedetomidine DRUG

Following confirmation of adequate spinal anesthesia, dexmedetomidine will be administered as an intravenous infusion of 0.2-0.4µg/kg/hr until abdominal closure.

Dexmedetomidine group

Virtual reality OTHER

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.

Virtual reality group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Women scheduled for elective cesarean section (CS) delivery.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Benha University

Banhā, Benha, 13518, Egypt

RECRUITING

MeSH Terms

Interventions

Dexmedetomidine

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Emad M Sayed, MBBCH

CONTACT

00201111710428; dr.emad.mohamedsayed@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Anesthesia and Intensive Care, Benha University, Benha, Egypt.

Study Record Dates

• First Submitted: January 7, 2026
• First Posted: January 15, 2026
• Study Start: January 17, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)