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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorBenha University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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 intervention

    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 groups

52 Participants
are divided into 2 treatment groups
Group A: Dexmedetomidine groupExperimental treatment 1 intervention
Group B: Virtual reality groupExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
Two hours postoperatively in the recovery room

Secondary outcomes

1

Heart rate

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

Time frame
24 hours postoperatively
2

Mean arterial pressure

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

Time frame
24 hours postoperatively
3

Peripheral Oxygen Saturation

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

Time frame
24 hours postoperatively
4

Stress Level

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.

Time frame
Two hours postoperatively in the recovery room

Other outcomes

Sponsors and contacts

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