Evaluating the Effectiveness of Virtual Reality Application in Caesarean Section

Ankara Yildirim Beyazıt University

Status: Active, not recruiting

Conditions: Vital Signs; Virtual Reality Pain Distraction; Birth Satisfaction; Apgar Score; Anxiety; Virtual Reality

Treatments: Device: Oculus Meta Quest 2 All In-One model virtual reality glasses

Study type: Interventional

Funder types: Other

Identifiers

NCT07080281

FC-AYBU-09-451

Details and patient eligibility

About

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?

Full 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.

Enrollment: 55 patients

Sex: Female

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 19 years of age and older,
• Turkish speaking,
• At least primary school graduate,
• Between 37th and 42nd weeks of pregnancy, primiparous and with a single fetus,
• No diagnosed psychiatric problem (anxiety disorder, bipolar disorder, schizophrenia, etc.),
• No epilepsy diagnosis,
• No hearing, vision or communication impairment,
• Spinal anesthesia planned,
• Pregnant women who volunteered to participate in the study were included.

Exclusion criteria

• Incomplete data collection forms,
• Participant's refusal to participate in the study at any stage,
• Use of general anesthesia/sedation during the cesarean section process,
• Only for pregnant women in the intervention group; not fully participating in the virtual reality glasses training, not using the virtual reality glasses for the desired duration, or having side effects of the virtual reality glasses (dizziness, headache, sweating, nausea, vomiting or eye strain) are the exclusion criteria from the study.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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55 participants in 2 patient groups

virtual reality group

Active Comparator group

Description:

group using virtual reality glasses

Treatment:

Device: Oculus Meta Quest 2 All In-One model virtual reality glasses

control group

No Intervention group

Description:

group without virtual reality glasses