Cesarean Section, Dexmedetomidine, Hemodynamics, Maternal Anxiety, Neonatal Outcomes, Stress, Virtual Reality
Conditions
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.
Detailed description
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.
Interventions
DRUGDexmedetomidine
Following confirmation of adequate spinal anesthesia, dexmedetomidine will be administered as an intravenous infusion of 0.2-0.4µg/kg/hr until abdominal closure.
OTHERVirtual 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.
Sponsors
Benha University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maternal anxiety | 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
| Measure | Time frame | Description |
|---|---|---|
| Heart rate | 24 hours postoperatively | Heart rate will be recorded at six predefined intra- and postoperative intervals. |
| Mean arterial pressure | 24 hours postoperatively | Mean arterial pressure will be recorded at six predefined intra- and postoperative intervals. |
| Peripheral Oxygen Saturation | 24 hours postoperatively | Peripheral Oxygen Saturation will be recorded at six predefined intra- and postoperative intervals. |
| Stress Level | 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. |
| Maternal Satisfaction | 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). |
| Apgar score | 5 minutes postoperatively | Apgar scores will be recorded at 1 and 5 minutes. |
Countries
Egypt
Contacts
CONTACTEmad M Sayed, MBBCH
Outcome results
None listed