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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexmedetomidine group | Experimental | 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 group | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
Women scheduled for elective cesarean section (CS) delivery.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Emad M Sayed, MBBCH | Contact | 00201111710428 | dr.emad.mohamedsayed@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Benha University | Recruiting | Banhā | Benha | 13518 | Egypt |
The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
After the end of study for one year.
The data will be available upon a reasonable request from the corresponding author.
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| Virtual reality | Other | 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. |
|
| 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 |
| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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