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The Effect of Virtual Reality on Anxiety, Stress, and Hemodynamic parameters among Primiparous Women During Cesarean Section: A Randomized controlled Clinical Trial

The Effect of Virtual Reality on Anxiety, Stress, and Hemodynamic parameters among Primiparous Women During Cesarean Section: A Randomized controlled Clinical Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20210131050192N2
Enrollment
350
Registered
2021-08-06
Start date
2021-08-01
Completion date
Unknown
Last updated
2021-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Caesarian section. Maternal care for scar from previous cesarean delivery

Interventions

Intervention 1: For the intervention group, the virtual reality glass (VR) will be applied after regional anesthesia
then, hemodynamic parameters were assessed before intervention, immediately after anesthesia, skin incision, delivery, skin suture, and two hours after surgery. Anxiety will be reassessed at siting on

Sponsors

Najran University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: Parturient with normal vision Parturient with normal hearing No history of generalized anxiety disorder No history of mental illness Free from serious obstetrics complications (according to the obstetrician evaluation) No increased intraoperative risk (e.g., placental disturbance) that identified in the preoperative period Accept to participate on the study.

Exclusion criteria

Exclusion criteria: Any woman developed intraoperative complication will be excluded from the study.

Design outcomes

Primary

MeasureTime frame
Stress. Timepoint: Stress will be reassessed after completing skin suture and two hours post-operative. Women is also asked about her satisfaction about the care provided. Method of measurement: Part III: Emotional preoperative stress (B-MEPS)Caumo (2016) first developed this scale, it will be developed to measure the emotional preoperative stress. It composed of 15 items, 3 of them rated on 4-point Likert scale, 11 of them rated on 3-point Likert scale and one of the have two answers. The high score indicates high stress.;Anxiety. Timepoint: Anxiety will be reassessed at siting on surgery table, after completing skin suturing, and recovery time (2 hours postoperative). Method of measurement: Part: IV: A novel visual facial anxiety scale for assessing preoperative anxiety Cao et al, 2017 developed this scale. This Self-reported scale to measure anxiety during clinical practices. It composed of six faces that asses different degrees of anxiety from none (1), mild (2), mild-moderate (3), moderate (4), moderate-high (5) and highest (6). The highest score indicates high degree of anxiety.;Hemodynamic parameters and fetal APGR score. Timepoint: hemodynamic parameters were assessed before intervention, immediately after anesthesia, skin incision, delivery, skin suture, and two hours after surgery. Method of measurement: Part II: Maternal hemodynamic parameters and newborn APGAR assessment sheet:The researchers developed this part after reviewing the current literature. This part will be used to register the maternal pulse, systolic, diastolic and mean blood pressure, respiratory rate and o2 saturation at patient admission, skin incision, delivery, skin suture and two hours after surgery. This part also contained questions about the incidence of nausea and drowsiness or vomiting. At the end of this part fetal APGAR sheet is present to asses at 1 and 5 minutes.

Countries

Saudi Arabia

Contacts

Public ContactWafaa Taha Elgzar

Najran University

wafaa.elgzar@nur.dmu.edu.eg+966 17 542 8888

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026