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Clinical Trial NCT07343843 for Virtual Reality, Dexmedetomidine, Maternal Anxiety, Stress, Hemodynamics, Neonatal Outcomes, Cesarean Section is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Virtual Reality Versus Intravenous Dexmedetomidine on Maternal Anxiety, Stress, Hemodynamics, and Neonatal Outcomes During Cesarean Section 52 Virtual
Clinical Trial NCT07343843 is an interventional study for Virtual Reality, Dexmedetomidine, Maternal Anxiety, Stress, Hemodynamics, Neonatal Outcomes, Cesarean Section that is recruiting. It started on 17 January 2026 with plans to enroll 52 participants. Led by Benha University, it is expected to complete by 1 July 2026. The latest data from ClinicalTrials.gov was last updated on 21 January 2026.
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 inte...
Show MoreOfficial Title
Effect of Virtual Reality Versus Intravenous Dexmedetomidine on Maternal Anxiety, Stress, Hemodynamics, and Neonatal Outcomes During Cesarean Section
Conditions
Virtual RealityDexmedetomidineMaternal AnxietyStressHemodynamicsNeonatal OutcomesCesarean SectionOther Study IDs
- MS.29.12.2025
NCT ID Number
Start Date (Actual)
2026-01-17
Last Update Posted
2026-01-21
Completion Date (Estimated)
2026-07-01
Enrollment (Estimated)
52
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Double
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalDexmedetomidine group Following confirmation of adequate spinal anesthesia, dexmedetomidine will be administered as an intravenous infusion of 0.2-0.4µg/kg/hr until abdominal closure. | Dexmedetomidine Following confirmation of adequate spinal anesthesia, dexmedetomidine will be administered as an intravenous infusion of 0.2-0.4µg/kg/hr until abdominal closure. |
ExperimentalVirtual reality group 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. | Virtual 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. |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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. | Two hours postoperatively in the recovery room |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Heart rate | Heart rate will be recorded at six predefined intra- and postoperative intervals. | 24 hours postoperatively |
Mean arterial pressure | Mean arterial pressure will be recorded at six predefined intra- and postoperative intervals. | 24 hours postoperatively |
Peripheral Oxygen Saturation | Peripheral Oxygen Saturation will be recorded at six predefined intra- and postoperative intervals. | 24 hours postoperatively |
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. | Two hours postoperatively in the recovery room |
Maternal Satisfaction | 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). | Two hours postoperatively in the recovery room |
Apgar score | Apgar scores will be recorded at 1 and 5 minutes. | 5 minutes postoperatively |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
Female
- 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.
- 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.
Benha UniversityStudy Responsible Party
Emad Mohamed Sayed, Principal Investigator, Resident of Anesthesia and Intensive Care, Benha University, Benha, Egypt.
Study Central Contact
Contact: Emad M Sayed, MBBCH, 00201111710428, [email protected]
1 Study Locations in 1 Countries
Benha
Benha University, Banhā, Benha, 13518, Egypt
Emad M Sayed, MBBCH, Contact, 00201111710428, [email protected]
Saad I Saad, MD, Sub-Investigator
Mohamed H Abdelrahman, MD, Sub-Investigator
Mona S Emara, MD, Sub-Investigator
Recruiting