Evaluation of the Effectiveness of Virtual Reality Application During Cesarean Delivery in Pregnant Women Undergoing Spinal Anesthesia
Phase: NA
Conditions: Virtual Reality Pain Distraction, Birth Satisfaction, Vital Signs, Anxiety, Apgar Score, Virtual Reality
Sponsor: Ankara Yildirim Beyazıt University

 
REPUBLIC OF TURKIYE 
ANKARA YILDIRIM BEYAZIT UNIVERSITY 
INSTITUTE OF HEALTH SCIENCES 
 
 
 
 
 
EVALUATION OF THE EFFECTIVENESS OF VIRTUAL 
REALITY APPLICATION DURING CESAREAN 
DELIVERY UNDER SPINAL ANESTHESIA 
 
 
 
 
STUDY PROTOCOL 
 
 
 
ANKARA- 30.06.2025 
 
 
 
 

Type and Setting of the Research 
This study was designed as a randomized controlled trial to evaluate the effectiveness of 
virtual reality intervention during cesarean delivery under spinal anesthesia in pregnant 
women. 
The study was conducted between November 2024 and June 2025 in the cesarean 
delivery unit of the Department of Obstetrics and Gynecology at a university hospital. 
Cesarean delivery plans are made one week in advance. Three days prior to delivery, 
pregnant women are called to the outpatient clinic for non-stress testing (NST), 
monitoring of vital signs, ultrasonography, laboratory tests, and preoperative instructions 
(including fasting 6–8 hours before surgery, antibiotic prophylaxis, removal of jewelry, 
hairpins, lenses, artificial nails, nail polish, etc., and a 48-hour postpartum hospital stay). 
Hospital admission is carried out between 07:00 and 08:00 on the day of delivery. 
Standard procedures, such as monitoring vital signs, NST, establishing intravenous 
access, anesthetic assessment and counseling, and obtaining written informed consent, 
are performed for admitted patients. Postpartum care is provided for 24 hours for vaginal 
deliveries and 48 hours for cesarean sections. This hospital was chosen for the study due 
to its high birth volume, status as one of the most preferred public hospitals in Ankara, its 
diverse patient population with varying socioeconomic and cultural backgrounds, and the 
researcher's affiliation with the institution. 
Population and Sample of the Research 
The population of the study consisted of pregnant women who applied to the antenatal 
outpatient clinic of the Department of Obstetrics and Gynecology of the relevant hospital 
and were scheduled for cesarean delivery. The sample was calculated based on Tuvanç's 
(2024) study (State-Trait Anxiety Inventory: Intervention Group X̄ ±SD: 59.78±6.61 and 
Control Group X̄ ±SD: 56.11±6.61). The sample size was calculated using the G*Power 
3.1.9.7 software. Based on power analysis with α (Type I error) = 0.05 and 80.7% power, 
a minimum of 52 pregnant women were required—26 in the intervention group and 26 in 
the control group. Considering a potential dropout rate during the study, the sample size 
was increased by 10%, and the study was completed with a total of 60 participants. To 
reduce selection bias and control variables potentially affecting outcomes, 162 pregnant 
women were assessed using an inclusion criteria form. Of these, 102 were excluded due 
to multiparity (n=82), illiteracy in Turkish (n=5), or unwillingness to participate (n=15). 
The remaining 60 eligible participants were randomly assigned to the intervention (n=30) 
and control (n=30) groups using simple randomization. Participants were numbered in 
order of cesarean scheduling and randomized via https://randomizer.org/randomize. 
Groups were coded as A and B, with letters randomly assigned via draw: A representing 
the intervention group and B the control group. To minimize bias, the groups were coded 
as “A” and “B” in the dataset for statistical blinding. 

In order to account for possible dropouts during the study, the sample size was increased 
by 10%, and the study was completed with a total of 60 pregnant women. To reduce 
selection bias and control variables that may affect outcome measures, 162 pregnant 
women were assessed using an eligibility criteria form. 
Of these, 102 did not meet the inclusion criteria (Multiparity (n=82), illiteracy in Turkish 
(n=5), lack of voluntary consent (n=15)). The remaining 60 eligible participants were 
randomly assigned to the intervention and control groups using simple random sampling 
(Intervention Group n=30, Control Group n=30). 
For the random assignment, participants were numbered based on the order they arrived 
for cesarean delivery and assigned using the website https://randomizer.org/randomize. 
To represent the intervention and control groups, the letters A and B were used. The 
group associated with each letter was randomly determined by draw; letter A represented 
the intervention group, and letter B represented the control group. 
To minimize bias, statistical blinding was applied by recording the groups in the database 
under the codes 'A' and 'B'. 
Inclusion Criteria 
• Aged 19 years or older, 
• Literate in Turkish, 
• At least a primary school graduate, 
• Between the 37th and 42nd weeks of gestation, primiparous with a single fetus, 
• Scheduled to receive spinal anesthesia, 
• Voluntarily agreed to participate in the study. 
Exclusion Criteria 
• Multiparous women, 
• Women with multiple pregnancies, 
• Diagnosed psychiatric disorders (e.g., anxiety disorders, bipolar disorder, 
schizophrenia), 
• Hearing, visual, or communication impairments, 
• Women who did not voluntarily agree to participate were excluded from the study. 
Withdrawal Criteria 
• Incomplete data collection forms, 
• Voluntary withdrawal from the study at any stage, 
• Administration of general anesthesia/sedation during the cesarean procedure, 
• For the intervention group only: failure to fully attend the VR headset training, non-
compliance with the prescribed usage duration of the VR headset, or presence of side 

effects related to VR use (e.g., dizziness, headache, sweating, nausea, vomiting, or eye 
fatigue). 
Dependent and Independent Variables of the Study 
Dependent Variables of the Study 
The dependent variables of the study include the use of a virtual reality headset, the 
Spielberger State-Trait Anxiety Inventory, the Visual Analogue Scale for Pain, and the 
Maternal Satisfaction with Cesarean Birth Scale. 
Independent Variables of the Study 
The independent variables of the study include sociodemographic characteristics, 
individual habits and obstetric features, characteristics of labor monitoring (preoperative 
vital signs, intraoperative vital signs, maternal anxiety expressions, neonatal Apgar score, 
side effects associated with VR headset use), and maternal vital signs in the postpartum 
period. 
Data Collection Tools 
The study utilized seven data collection tools: Eligibility Criteria Form, Individual 
Information Form (IIF), Pregnant Monitoring Form - Intervention Group (PMF-IG), 
Pregnant Monitoring Form - Control Group (PMF-CG), Spielberger State-Trait Anxiety 
Inventory (STAI), and the Maternal Satisfaction with Cesarean Birth Scale. 
Eligibility Criteria Form 
This form, prepared based on the literature, includes ten questions assessing age, literacy 
in Turkish, educational background, gestational week, primiparity, presence of a single 
fetus, diagnosed psychiatric condition, sensory or communication impairments, and 
planned type of anesthesia. Each question is answered with 'Yes' or 'No'. Participants who 
answered 'Yes' to questions 1, 2, 3, 4, 5, 6, 9, and 10, and 'No' to questions 7 and 8 were 
included in the study. 
Individual Information Form 
Prepared based on literature review, the Individual Information Form (IIF) consists of 
two sections with a total of 11 items aimed at identifying the demographic and obstetric 
characteristics of pregnant women. This form was filled out by the participants. 
The first section includes five questions regarding age, educational background, 
employment status, engagement in regular physical activity (at least 150 minutes of 
moderate activity per week, WHO, 2024), and smoking habits. 

The second section consists of six items assessing obstetric characteristics such as 
gestational week, whether the pregnancy was planned, history of abortion, history of 
curettage, number of antenatal follow-ups, and sources of information regarding cesarean 
delivery. 
Pregnant Monitoring Form – Intervention Group 
The Pregnant Monitoring Form for the Intervention Group (PMF-IG) consists of three 
sections and was completed by the researcher based on observations and hemodynamic 
measurements. 
The first section records preoperative vital signs (heart rate, blood pressure, respiratory 
rate, and oxygen saturation) between 6–12 hours before the cesarean procedure. 
The second section tracks intraoperative vital signs, pain level using the Visual Analogue 
Scale, side effects related to VR headset use, and the newborn's Apgar score. 
The third section includes postpartum vital signs observed between 8–12 hours after 
delivery. 
Pregnant Monitoring Form – Control Group 
The Pregnant Monitoring Form for the Control Group (PMF-CG) also consists of three 
sections and was completed by the researcher based on observations and hemodynamic 
measurements. 
The first section monitors vital signs (heart rate, blood pressure, respiratory rate, and 
oxygen saturation) in the preoperative period between 6–12 hours before the procedure. 
The second section includes intraoperative monitoring of maternal vital signs, pain level 
using the Visual Analogue Scale, and the newborn's Apgar score. 
The third section documents the postpartum vital signs recorded between 8–12 hours 
following delivery. 
Visual Analogue Scale for Pain 
The Visual Analogue Scale (VAS) was first developed in 1921 by Hayes and Patterson 
and is widely used to measure pain intensity. In addition to pain severity, it provides 
information on how negatively the patient feels due to the pain. 
The VAS consists of a 10-cm line, either horizontal or vertical, with 'no pain' at one end 
and 'unbearable pain' at the other. Patients are asked to mark the point that best represents 
their level of pain. 

The score is then measured numerically, where a score of '0' indicates no pain and '10' 
indicates the most severe pain. The average score typically ranges between 5 and 6. A 
higher score reflects a greater intensity of perceived pain. 
In this study, the Visual Analogue Scale was included in the Pregnant Monitoring Form. 
Spielberger Trait Anxiety Inventory 
The Spielberger Trait Anxiety Inventory (STAI-T) was developed by Spielberger and 
colleagues in 1970. The scale was adapted into Turkish and validated by Öner and Le 
Compte in 1985. 
This inventory is used to assess how individuals generally feel and includes 20 items. It is 
rated on a 4-point Likert scale: 1 (almost never), 2 (sometimes), 3 (often), and 4 (almost 
always). 
There are seven reverse-scored items in the trait anxiety scale: items 21, 26, 27, 30, 33, 
36, and 39. The reverse-scored items are coded as 4, 3, 2, and 1 instead of their original 1 
to 4 ratings. 
Separate answer keys are created for direct and reverse-scored items. The total score is 
calculated by subtracting the sum of reverse scores from the sum of direct scores, and 
then adding a fixed constant value of 35. 
The total score ranges between 20 and 80. The average score typically falls between 36 
and 41. Higher scores indicate higher levels of anxiety. The Cronbach’s alpha for the trait 
anxiety scale in this study was found to be 0.80. 
Spielberger State Anxiety Inventory 
The Spielberger State Anxiety Inventory (STAI-S) was developed by Spielberger and 
colleagues in 1970 and adapted into Turkish by Öner and Le Compte in 1985. 
It consists of 20 items used to evaluate the participant’s current state of anxiety. The 
items are rated on a 4-point Likert scale: 1 (not at all), 2 (somewhat), 3 (moderately so), 
and 4 (very much so). 
There are ten reverse-scored items: items 1, 2, 5, 8, 10, 11, 15, 16, 19, and 20. These 
items are reverse-coded in scoring. 
Separate answer keys are prepared for direct and reverse-scored items. The state anxiety 
score is calculated by subtracting the reverse score total from the direct score total and 
adding a constant of 50. 

The total score ranges from 20 to 80, with typical scores falling between 36 and 41. 
Higher scores indicate greater anxiety levels. The Cronbach’s alpha value for this scale in 
the study ranged between 0.80 and 0.87. 
Maternal Satisfaction with Cesarean Birth Scale 
The Maternal Satisfaction with Cesarean Birth Scale (MSCBS) was developed by 
Güngör and Beji (2009) to evaluate maternal experiences during cesarean birth and in the 
early postpartum period. 
The scale consists of 42 items and 10 subdimensions: perception of the healthcare team 
(items 1–5), preparation for cesarean (items 6–7), relaxation (items 8–10), participation in 
decisions and information (items 11–18), meeting the baby (items 19–21), postpartum 
care (items 22–27), hospital room (items 28–30), hospital facilities (items 31–33), respect 
for privacy (items 34–37), and fulfillment of expectations (items 38–42). 
It is a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). 
Twelve items (8, 9, 10, 19, 20, 21, 22, 34, 35, 37, 40, 41) are reverse-scored. 
After reverse scoring, total scale and subdimension scores are calculated by summing the 
item scores. The total score ranges between 42 and 210, with higher scores indicating 
greater maternal satisfaction. 
The cut-off score for high satisfaction was set at 146.5 (≥146.5 = high satisfaction, 
<146.5 = low satisfaction). The Cronbach’s alpha value for this scale was reported as 
0.87. 
Preparation of Research Materials 
Virtual Reality Headset Training Brochure 
A training brochure was prepared to inform pregnant women in the intervention group 
about the virtual reality application during the preoperative period. The brochure included 
detailed explanations about the effects, usage areas, and potential side effects of the VR 
headset. 
Implementation of the Study 
The study was conducted in three stages. In the first stage, pregnant women who met the 
inclusion criteria and volunteered to participate were randomly assigned to intervention 
and control groups. 
In the second stage, the intervention group received a virtual reality application during 
cesarean delivery, while the control group received only routine hospital procedures. 

In the third stage, the levels of pain, anxiety, and maternal satisfaction experienced during 
the cesarean section were evaluated between 8–12 hours postpartum. 
Stage One: As part of the study, women who were scheduled for cesarean delivery were 
informed about the study during routine tests conducted three days before the operation. 
These included a non-stress test (NST), vital signs monitoring, ultrasonography, 
laboratory examinations, and preoperative preparations. 
Volunteering participants completed the 'Eligibility Criteria Form.' Those who met the 
inclusion criteria were randomly assigned to the intervention and control groups using 
simple random sampling through the website https://randomizer.org/randomize based on 
their order of clinic admission. 
Participants assigned to the groups were visited 6–12 hours before cesarean delivery in 
their hospital rooms. They completed the 'Individual Information Form,' the 'Spielberger 
Trait Anxiety Inventory,' and the 'Spielberger State Anxiety Inventory.' 
In both groups, researchers conducted hemodynamic measurements and recorded 
preoperative vital signs in the first section of the Pregnant Monitoring Form. 
In addition, pregnant women in the intervention group received training about the VR 
headset application and underwent a 5-minute trial to assess potential side effects. After 
training, they were given the 'VR Headset Training Brochure.' 
Stage Two: At this stage, the identities of the pregnant women in both groups were 
verified, and they were admitted to the operating room. 
During this process, spinal anesthesia was administered by an anesthesiologist using a 
22-gauge spinal needle at the L3-L4 or L4-L5 interspace, with 10 mg of bupivacaine and 
0.05 mg of morphine diluted in 3 ml injected into the subarachnoid space. 
In the intraoperative period, the virtual reality intervention was applied twice to the 
pregnant women in the intervention group. 
The first VR application was performed for approximately 5 minutes during the 
assessment of the effectiveness of spinal anesthesia and was removed to allow the patient 
to rest. The resting period, during which spinal anesthesia takes full effect, averaged 
about 10 minutes. 
The second VR application was initiated at the time of surgical incision and continued 
until the head, extremity, or breech of the fetus was visible, approximately lasting 10 
minutes. The VR application was terminated upon birth of the newborn. 
To assess anxiety levels during the cesarean, the Spielberger State Anxiety Inventory was 
administered during the spinal anesthesia rest phase. 

In addition, maternal vital signs, pain levels, side effects related to VR use, and the 
newborn’s Apgar score were recorded by the researcher on the Pregnant Monitoring 
Form. 
The VR headset used in this study was the Meta Quest 2 All-in-One model by Oculus. It 
is a head-mounted display, with each lens offering a resolution of 1832x1920 pixels and a 
360° field of view. 
The pregnant women in the intervention group viewed a licensed video titled 'Breathe – 
Relax and Meditate' via the Meta Horizon application on the VR headset. 
To maintain hygiene and comfort, a disposable VR headset cover and single-use surgical 
cap were used around the forehead and ears during application. The headset was 
disinfected before each use. 
According to the literature, the maximum duration of VR application should not exceed 
20 minutes due to potential side effects such as dizziness, headache, nausea, vomiting, 
and eye fatigue. Therefore, the VR sessions in this study were limited to 15 minutes to 
minimize adverse effects. 
In the control group, no additional interventions were performed other than the routine 
cesarean delivery procedures. 
To assess anxiety levels during the cesarean, the Spielberger State Anxiety Inventory was 
administered during the spinal anesthesia rest phase. 
During the cesarean delivery, maternal vital signs, pain scores, and the newborn’s Apgar 
scores were recorded by the researcher on the Pregnant Monitoring Form. 
Stage Three: In this final stage, participants from both groups were visited in the ward 
within the first 8–12 hours postpartum. The 'Maternal Satisfaction with Cesarean Birth 
Scale' was completed by the participants. 
Additionally, maternal vital signs were measured and recorded in the Pregnant 
Monitoring Form. 
Ethical Considerations of the Research 
Before commencing the study, ethical approval was obtained from the Ethics Committee 
of Ankara Yıldırım Beyazıt University Faculty of Health Sciences and written permission 
was secured from the hospital where the study was conducted. 
Participants were informed about the study’s purpose and content, and written informed 
consent was obtained. 

They were assured that all personal data would remain confidential and that they could 
withdraw from the study at any time without any consequences. 
Permissions for the use of the data collection tools were obtained from the respective 
scale authors via email.