NCT07080281

Evaluating the Effectiveness of Virtual Reality Application in Caesarean Section

Evaluation of the Effectiveness of Virtual Reality Application During Cesarean Delivery in Pregnant Women Undergoing Spinal Anesthesia

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Ankara Yildirim Beyazıt University · Academic / Other
• Sex: Female
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

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?

Detailed description

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.

Conditions

• Virtual Reality Pain Distraction
• Birth Satisfaction
• Vital Signs
• Anxiety
• Apgar Score
• Virtual Reality

Interventions

Type	Name	Description
DEVICE	Oculus Meta Quest 2 All In-One model virtual reality glasses	During the caesarean section, Meta Quest 2 All In-One model virtual reality glasses from Oculus were used for 15 minutes. In this virtual environment, the licensed product video "Breathe- Relax and Meditate" was watched via the "Meta Horizon" application.

Timeline

• Start date: 2024-11-15
• Primary completion: 2025-06-01
• Completion: 2025-07-15
• First posted: 2025-07-23
• Last updated: 2025-07-23

Locations

1 site across 1 country: Turkey (Türkiye)