Virtual Reality Pain DistractionNCT07080281
Evaluating the Effectiveness of Virtual Reality Application in Caesarean Section
A study testing Oculus Meta Quest 2 All In-One model virtual reality glasses in people with Virtual Reality Pain Distraction and Birth Satisfaction, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older, women only
- Conditions the study is for
- Virtual Reality Pain Distraction, Birth Satisfaction, Vital Signs
- What is being tested?
- Oculus Meta Quest 2 All In-One model virtual reality glasses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Nov 2024to 15 Jul 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
Show all 9Show fewer
- No hearing, vision or communication impairment,
- Spinal anesthesia planned,
- Pregnant women who volunteered to participate in the study were included.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Yildirim Beyazit University, Faculty Of Health Sciences
Ankara, Çubuk, 06760
About this study
Official title: Evaluation of the Effectiveness of Virtual Reality Application During Cesarean Delivery in Pregnant Women Undergoing Spinal Anesthesia
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:
- 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?
- 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?
- 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?
- Is there a significant difference between the vital signs of pregnant women in the intervention group and those in the control group?
- Is there a significant difference between the mean apgar scores of the pregnant women in the intervention group and those in the control group?
Read the 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
- Being tested
- Oculus Meta Quest 2 All In-One model virtual reality glasses
- Keywords
- labor pain, cesarean section, birth satisfaction, birth anxiety, apgar scores, virtual reality, hemodynamic parameters
- Medical subject headings
- Anxiety Disorders, Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oculus Meta Quest 2 All In-One model virtual reality glassesDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| virtual reality group | Active comparator | group using virtual reality glasses Receives: Device: Oculus Meta Quest 2 All In-One model virtual reality glasses |
| control group | No intervention | group without virtual reality glasses |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Between 0-25th minutes of cesarean delivery
Secondary outcomes (6)
labor pain
Labor pain is a biopsychosocial process because it is a multifaceted, subjective and personal phenomenon perceived by pregnant women. The probability of experiencing pain during a cesarean section is 0.5-17% in pregnant women who undergo spinal anesthesia. Pain during a cesarean section plays an effective role in the severity of pain in the postpartum period. The severity of pain in the postpartum period has negative effects such as negative maternal bonding, postpartum depression, post-traumatic stress disorder, and prolonged hospital stay.The effectiveness of virtual reality application, a nonpharmacological method option in the management of pain perception during labor, was evaluated. Virtual reality is used as a distraction method by completely removing the individual from the area they are in. Visual analog scale was used in pain assessment. The scale in question is numbered from 0 to 10. Increasing number given to the scale indicates high pain.
Measured: Between 0-25th minutes of cesarean delivery
blood pressure
A cesarean section can trigger activation of the sympathetic nervous system, leading to increased blood pressure. Blood pressure is expressed in units of pressure, also known as "mmHg" or "torr." High blood pressure is a sign of poor health.
Measured: 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
A cesarean section can trigger sympathetic nervous system activation, causing an increase in heart rate. Heart rate is expressed as beats per minute (bpm). A high heart rate indicates poor health.
Measured: 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
A cesarean section can trigger sympathetic nervous system activation, causing an increase in respiratory rate. Respiratory rate is expressed as the number of breaths per minute. A high respiratory rate indicates poor health.
Measured: 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
A cesarean section can trigger sympathetic nervous system activation, leading to a decrease in peripheral oxygen saturation. Oxygen saturation is the ratio of oxygen-saturated hemoglobin to total hemoglobin in the blood and is expressed as a percentage. Approaching 100% is considered positive. Low peripheral oxygen saturation indicates poor health.
Measured: 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
apgar scores
Apgar Score Scale is a scale used to evaluate the general condition of the newborn and objectively measure the response to resuscitation practices. Apgar score is based on five clinical parameters; heart rate, respiration, muscle tone, reflex response and skin color. Each parameter is scored as 0, 1 and 2 according to predefined criteria. The minimum score that can be obtained from this scale is ''0'' and the maximum score is ''10''. An increase in the score indicates that the newborn's condition is good. Heart rate is expressed in the number of heartbeats in 1 minute and bpm. Each of these measurements will be evaluated separately. Respiration is evaluated according to whether breathing progresses regularly.
Measured: 1th and 5th minutes of the baby's birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2025
- Study start15 Nov 2024
- Primary completion1 Jun 2025
- Study completion15 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Virtual Reality Pain DistractionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Yildirim Beyazıt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Çelik, Ankara Yildirim Beyazıt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07080281
- Sponsor's protocol ID
- FC-AYBU-09-451
- Status last verified
- Jul 2025
- First submitted
- 15 May 2025
- Last updated
- 23 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of Virtual Reality Application During Cesarean Delivery in Pregnant Women Undergoing Spinal Anesthesia
- ClinicalTrials.gov ID
- NCT07080281
- Acronym / sponsor ID
- FC-AYBU-09-451
- 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
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Ankara Yildirim Beyazıt UniversityUniversity, hospital or other
- Study start
- 15 Nov 2024 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 15 Jul 2025 (estimated)
- First posted
- 23 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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?
- 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?
- 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?
- Is there a significant difference between the vital signs of pregnant women in the intervention group and those in the control group?
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| virtual reality group | Active comparator | Device: Oculus Meta Quest 2 All In-One model virtual reality glassesgroup using virtual reality glasses |
| control group | No intervention | –group without virtual reality glasses |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.),
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oculus Meta Quest 2 All In-One model virtual reality glassesDuring 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. | Device | virtual reality group |
Primary outcome
State-Trait Anxiety Inventory
Time frame: 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.
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.
Maternal Satisfaction Evaluation Scale (Cesarean Section)
Time frame: Between 0-25th minutes of cesarean delivery
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.
6 secondary outcomes
labor pain
Time frame: Between 0-25th minutes of cesarean delivery
blood pressure
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
apgar scores
Time frame: 1th and 5th minutes of the baby's birth
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oculus Meta Quest 2 All In-One model virtual reality glasses in people with Virtual Reality Pain Distraction and Birth Satisfaction, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 23 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
State-Trait Anxiety Inventory (time frame: 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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2025.