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Evaluation of the Effectiveness of Virtual Reality Application During Cesarean Delivery in Pregnant Women Undergoing Spinal Anesthesia
The aim of this study was to evaluate the effects of virtual reality intervention during cesarean delivery under spinal anesthesia on labor pain, anxiety, satisfaction and hemodynamic parameters in primiparous pregnant women. The main questions it aims to answer are: 1. Is there a significant difference between the mean intraoperative pain scores of the pregnant women in the intervention group and those in the control group? 2. Is there a significant difference between the mean intraoperative anxiety scores of the pregnant women in the intervention group and those in the control group? 3. Is there a significant difference between the mean birth satisfaction scores of the pregnant women in the intervention group and those in the control group? 4. Is there a significant difference between the vital signs of pregnant women in the intervention group and those in the control group? 5. Is there a significant difference between the mean apgar scores of the pregnant women in the intervention group and those in the control group?
The study was conducted in the cesarean section unit of a university hospital. Pregnant women who were planned for cesarean section and applied to the outpatient clinic for routine examinations such as non-stress test (NST) and monitoring of vital signs, ultrasound, laboratory tests, information about preoperative preparation (stopping oral intake 6-8 hours before cesarean section, antibiotic prophylaxis, not wearing jewelry, hair clips, contact lenses, artificial nails, nail polish, etc., and 48 hours of hospital stay in the postpartum period) were informed about the study and the "Research Inclusion Criteria Form" was applied. In order to assign equally to the intervention and control groups of pregnant women who met the inclusion criteria and volunteered, they were assigned numbers according to the order of their application to the outpatient clinic and simple random sampling method was used on the website https://randomizer.org/randomize. All pregnant women were informed about the purpose, content and duration of the study and their written consent was obtained. During the process in which the effectiveness of spinal anesthesia was evaluated, virtual reality glasses were applied to pregnant women in the intervention group for approximately 5 minutes and then removed to rest. The resting period lasted an average of 10 minutes, although it varied depending on the patient in whom the effect of spinal anesthesia was complete. The second application of the virtual reality glasses was applied for approximately 10 minutes from the opening of the surgical incision line until the head/extremity/rectum of the fetus was visible. The virtual reality glasses application was terminated at the moment the newborn was born. No intervention was made to the control group during these procedures. The virtual reality glasses applied to the intervention group during the cesarean delivery are the Meta Quest 2 All In-One model from the Oculus brand, which can be worn on the head. Thanks to its head-mountable feature, the glasses isolate the real world. Each of the glasses' lenses has a resolution of 1832x1920 pixels and a 360˚ field of view. The glasses are used by pairing them with the ''Meta Horizon'' application purchased from application markets. The "Breathe- Relax \& Meditate" licensed product video, which can be purchased from the "Meta Horizon" application, will be played on the virtual reality glasses. This product includes videos with images of lakes, forests, waterfalls, beaches, and rivers, along with a meditation music background.
Age
19 - No limit years
Sex
FEMALE
Healthy Volunteers
No
Ankara Yildirim Beyazit University, Faculty Of Health Sciences
Ankara, Çubuk, Turkey (Türkiye)
Start Date
November 15, 2024
Primary Completion Date
June 1, 2025
Completion Date
July 15, 2025
Last Updated
July 23, 2025
55
ACTUAL participants
Oculus Meta Quest 2 All In-One model virtual reality glasses
DEVICE
Lead Sponsor
Ankara Yildirim Beyazıt University
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT06587321