]>
IRCT20210131050192N2 IRCT 2021-08-06 Najran University 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 2021-08-01 anticipated 350 Complete https://irct.ir/trial/57814 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: The participants will be randomly assigned to intervention or control group through randomization block technique. Six steps were followed to carryout participants' assignment using randomization block technique. First, the investigators will write a list contains numbers from 1 to 350. Second; the investigators will prepare small pieces of papers that comprise numbers from 1 to 350. Third; the investigators will fold each piece of papers to hide the written number, then it will be collected in a large bowl. Fourth; the researchers divided the 350 pieces of papers into 35 blocks in a random and blind manner. Each block contains 10. Fifth; from each block, five pieces of papers will be selected randomly and blindly to the intervention group and the remaining 5 pieces of papers will be assigned to the control group. A total of 175 numbers will be assigned to each group. Sixth; the classification of cases will be recorded in the pre-prepared list (the word intervention or control will be recorded in front of each number) to be considered at the time of data collection. The intervention group (G1) included 175 participants and the control group (G2) involved 175 patients who will be submitted to routine care. N/A Caesarian section. 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 surgery table, after completing skin suturing, and recovery time (2 hours postoperative). Stress will be reassessed after completing skin suture and two hours post-operative. Women is also asked about her satisfaction about the care provided. Intervention 2: For the control group, they were left for routine hospital care. The same measurement timing for stress, anxiety, hemodynamic parameters neonatal APGAR score and maternal satisfaction about care provided were followed. Yes - There is a plan to make this available What will be shared: published research report that contains all the study findings When: within one year and will be available long life To whom: public Conditions: for scientific use and public education Where to obtain: non How to obtain: non Comments: non
public Wafaa Taha Elgzar
Elmashalia Najran University campus
Najran Saudi Arabia 66241 +966 17 542 8888 wafaa.elgzar@nur.dmu.edu.eg Najran University scientific Wafaa Taha Elgzar
Elmashalia Najran University campus
Najran Saudi Arabia 66241 +966 17 542 8888 wafaa.elgzar@nur.dmu.edu.eg Najran University Saudi Arabia 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. 18 years 45 years Female Any woman developed intraoperative complication will be excluded from the study. O34.21 Maternal care for scar from previous cesarean delivery Treatment - Other Treatment - Other 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 surgery table, after completing skin suturing, and recovery time (2 hours postoperative). Stress will be reassessed after completing skin suture and two hours post-operative. Women is also asked about her satisfaction about the care provided. For the control group, they were left for routine hospital care. The same measurement timing for stress, anxiety, hemodynamic parameters neonatal APGAR score and maternal satisfaction about care provided were followed. 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. Najran University Approved 2021-04-25 Najran University ethics committee Elmashalia Najran University campus Najran Najran Saudi Arabia