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NCT Number: NCT07343843

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Benha University

Banhā, Benha, 13518, Egypt

Location status: Recruiting

Location contact

Emad M Sayed, MBBCH

CONTACT

[email protected]

00201111710428

Mohamed H Abdelrahman, MD

SUB_INVESTIGATOR

Mona S Emara, MD

SUB_INVESTIGATOR

Saad I Saad, MD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Maternal anxiety

    Time frame: 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.

Secondary outcomes

  1. Heart rate

    Time frame: 24 hours postoperatively

    Heart rate will be recorded at six predefined intra- and postoperative intervals.

  2. Mean arterial pressure

    Time frame: 24 hours postoperatively

    Mean arterial pressure will be recorded at six predefined intra- and postoperative intervals.

  3. Peripheral Oxygen Saturation

    Time frame: 24 hours postoperatively

    Peripheral Oxygen Saturation will be recorded at six predefined intra- and postoperative intervals.

  4. Stress Level

    Time frame: Two hours postoperatively in the recovery room

    Stress Levels will be measured using the Brief Measure of Emotional Preoperative Stress (B-MEPS) on admission to the operating theatre, at skin suturing, and two hours postoperatively in the recovery room.

    The B-MEPS will be used to assess maternal stress levels. This 12-item tool will be designed as a shorter version of the full Emotional Preoperative Stress scale. It includes items rated on 2-point, 3- point, and 4-point Likert scales, with higher total scores (range 12-36) indicating greater preoperative stress.

  5. Maternal Satisfaction

    Time frame: Two hours postoperatively in the recovery room

    Maternal satisfaction will be evaluated using the Birth Satisfaction Scale-Revised (BSS-R), a widely used and validated instrument in obstetric research. The BSSR comprises 10 items rated on a 5-point Likert scale, ranging from "strongly disagree" [1] to "strongly agree" [5]. Scores will categorize participants into: completely unsatisfied (10-18), unsatisfied (19-26), neutral (27-34), satisfied (35-42), or completely satisfied (43-50).

  6. Apgar score

    Time frame: 5 minutes postoperatively

    Apgar scores will be recorded at 1 and 5 minutes.

Study contacts

Contact information is provided by the study sponsor or research team.

Emad M Sayed, MBBCH

CONTACT

[email protected]

00201111710428

Sponsors and collaborators

Lead sponsor

Benha University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 15, 2026
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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