Benha University
Banhā, Benha, 13518, Egypt
Location status: Recruiting
Location contact
Emad M Sayed, MBBCH
CONTACT
Mohamed H Abdelrahman, MD
SUB_INVESTIGATOR
Mona S Emara, MD
SUB_INVESTIGATOR
Saad I Saad, MD
SUB_INVESTIGATOR
NCT Number: NCT07343843
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.
Interested in participating?
Request Info18 year and older
Female
Interventional
Not applicable
Banhā, Benha, 13518, Egypt
Location status: Recruiting
Emad M Sayed, MBBCH
CONTACT
Mohamed H Abdelrahman, MD
SUB_INVESTIGATOR
Mona S Emara, MD
SUB_INVESTIGATOR
Saad I Saad, MD
SUB_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Following confirmation of adequate spinal anesthesia, dexmedetomidine will be administered as an intravenous infusion of 0.2-0.4µg/kg/hr until abdominal closure.
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.
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.
Time frame: 24 hours postoperatively
Heart rate will be recorded at six predefined intra- and postoperative intervals.
Time frame: 24 hours postoperatively
Mean arterial pressure will be recorded at six predefined intra- and postoperative intervals.
Time frame: 24 hours postoperatively
Peripheral Oxygen Saturation will be recorded at six predefined intra- and postoperative intervals.
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.
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).
Time frame: 5 minutes postoperatively
Apgar scores will be recorded at 1 and 5 minutes.
Contact information is provided by the study sponsor or research team.
Benha University
Other
Effect of Virtual Reality Versus Intravenous Dexmedetomidine on Maternal Anxiety, Stress, Hemodynamics, and Neonatal Outcomes During Cesarean Section
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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