Evaluating the Effectiveness of Virtual Reality Application in Caesarean Section

NCT ID: NCT07080281

Last Updated: 2025-07-23

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-15
• Study Completion Date: 2025-07-15

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

virtual reality group

group using virtual reality glasses

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DEVICE

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.

control group

group without virtual reality glasses

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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,

• Minimum Eligible Age: 19 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ankara Yildirim Beyazıt University

OTHER

Sponsor Role: lead

Responsible Party

Fatma Çelik

Nurse

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ankara Yildirim Beyazit University, Faculty Of Health Sciences

Ankara, Çubuk, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form: control group consent form

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

FC-AYBU-09-451

Identifier Type: -

Identifier Source: org_study_id