Evaluating the Effectiveness of Virtual Reality Application in Caesarean Section

NCT07080281 | Active Not Recruiting

• 1 other identifier: FC-AYBU-09-451
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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. 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. 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. 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. 4.Is there a significant difference between the vital signs of pregnant women in the intervention group and those in the control group?
5. 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?

Conditions

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

Keywords

labor pain; cesarean section; birth satisfaction; birth anxiety; apgar scores; virtual reality; hemodynamic parameters

Outcome Measures

Primary Outcomes (2)

• State-Trait Anxiety Inventory

  Pregnancy, birth and the transition to parenthood are important milestones in a woman's life, both physically, emotionally and socially. A cesarean section is an anxious process because it is both a birth and a surgical intervention. Especially for those who are giving birth for the first time, fears that the mother will experience pain during birth and possible risks to the health of the mother and newborn increase the anxiety and concerns about this process. In the management of anxiety during pregnancy, birth and postpartum periods, pharmacological interventions are avoided due to their possible negative effects on the fetus. This situation increases the importance of using nonpharmacological methods in the management of anxiety. The minimum score obtained from the scale is 20, the maximum score is 80. A high score obtained from the scale means that anxiety is high. The cut-off score of the scale is 39-40.

  Birth anxiety was assessed at two different times. The first; 6-12 hours before cesarean delivery, and the second; was during the cesarean section, between 6-15th minutes.

• Maternal Satisfaction Evaluation Scale (Cesarean Section)

  It is reported that birth satisfaction is an important parameter in protecting mother-baby health. Therefore, birth satisfaction is one of the important indicators of the quality of health care provided. The World Health Organization recommends that a birth care should be organized and provided in order to ensure a positive birth experience, where women can make conscious choices and receive uninterrupted support throughout the labor and delivery process. Birth support during birth, use of evidence-based practices, use of non-pharmacological methods in anxiety and pain management, implementation of practices in cooperation with the woman, communication, informing the woman about the process, using positive language, and respecting privacy are the roles of health professionals in increasing birth satisfaction. The total raw score varies between 42-210. As the total score from the scale increases, the mothers' satisfaction levels with cesarean birth increase. The cut-off score 146.5.

  Between 0-25th minutes of cesarean delivery

Secondary Outcomes (6)

• labor pain

  Between 0-25th minutes of cesarean delivery

• blood pressure

  blood pressure were measured at 3 different times: 6-12th hours before cesarean delivery, 0-25th minutes during cesarean section, and finally between 8-12th hours in the postpartum period

• heart rate

  heart rate were measured at 3 different times: 6-12th hours before cesarean delivery, 0-25th minutes during cesarean section, and finally between 8-12th hours in the postpartum period

• respiratory rate

  respiratory rate were measured at 3 different times: 6-12th hours before cesarean delivery, 0-25th minutes during cesarean section, and finally between 8-12th hours in the postpartum period

• peripheral oxygen saturation

  peripheral oxygen saturation were measured at 3 different times: 6-12th hours before cesarean delivery, 0-25th minutes during cesarean section, and finally between 8-12th hours in the postpartum period

Study Arms (2)

virtual reality group

ACTIVE COMPARATOR

group using virtual reality glasses

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

control group

NO INTERVENTION

group without virtual reality glasses

Interventions

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

virtual reality group

Eligibility Criteria

• Age: 19 Years+
• Gender Eligibility Details: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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,

Sponsors & Collaborators

• Ankara Yildirim Beyazıt University: lead

Study Sites (1)

Ankara Yildirim Beyazit University, Faculty Of Health Sciences

Ankara, Çubuk, 06760, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders; Labor Pain

Condition Hierarchy (Ancestors)

Mental Disorders; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nurse

Study Record Dates

• First Submitted: May 15, 2025
• First Posted: July 23, 2025
• Study Start: November 15, 2024
• Primary Completion: June 1, 2025
• Study Completion: July 15, 2025
• Last Updated: July 23, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)