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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
Dexmedetomidine
DrugFollowing 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 interventionParticipants 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
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Heart rate
Heart rate will be recorded at six predefined intra- and postoperative intervals.
Mean arterial pressure
Mean arterial pressure will be recorded at six predefined intra- and postoperative intervals.
Peripheral Oxygen Saturation
Peripheral Oxygen Saturation will be recorded at six predefined intra- and postoperative intervals.
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.
Sponsors and contacts
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