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

NCT ID: NCT07343843

Last Updated: 2026-01-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-17

Study Completion Date

2026-07-01

Brief Summary

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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

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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.

Conditions

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Virtual Reality Dexmedetomidine Maternal Anxiety Stress Hemodynamics Neonatal Outcomes Cesarean Section

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Dexmedetomidine group

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

Group Type EXPERIMENTAL

Dexmedetomidine

Intervention Type 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.

Virtual reality group

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.

Group Type EXPERIMENTAL

Virtual reality

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Benha University

OTHER

Sponsor Role lead

Responsible Party

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Emad Mohamed Sayed

Resident of Anesthesia and Intensive Care, Benha University, Benha, Egypt.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Benha University

Banhā, Benha, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Emad M Sayed, MBBCH

Role: CONTACT

00201111710428

Facility Contacts

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Emad M Sayed, MBBCH

Role: primary

00201111710428

Other Identifiers

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MS.29.12.2025

Identifier Type: -

Identifier Source: org_study_id

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