Caesarean SectionNCT07247643
The Impact of Virtual Reality Glasses on Maternal Satisfaction and Postpartum Comfort in Cesarean Sections Performed Under Spinal Anesthesia
A study testing (Intervention Group): Virtual Reality Glasses in people with Caesarean Section, run by Büşra Küçüktürkmen.
Trial summary
Due to the stressful nature of cesarean birth, it is important that the use of virtual reality (VR) glasses is both feasible and effective. While wearing VR glasses, the distraction effect can reduce women's focus on pain and the surgical procedure itself. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Caesarean Section
- What is being tested?
- (Intervention Group): Virtual Reality Glasses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- No sites listed yet
- Study dates
- 15 Nov 2025to 30 Jan 2026
- 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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women aged 18-45 years
- Undergoing elective repeat cesarean section under spinal anesthesia
- Able to communicate in Turkish and provide informed consent
- Singleton pregnancy
Who cannot join
- Presence of obstetric or medical complications requiring general anesthesia
- Emergency cesarean sections
- Psychiatric or neurological disorders that may interfere with VR use
- Contraindications to spinal anesthesia
- Visual or hearing impairments preventing effective use of VR glasses
About this study
Due to the stressful nature of cesarean birth, it is important that the use of virtual reality (VR) glasses is both feasible and effective. While wearing VR glasses, the distraction effect can reduce women's focus on pain and the surgical procedure itself. Furthermore, VR applications have been shown to increase women's satisfaction with the birth experience. This study will be conducted as a randomized controlled trial. A total of 96 participants will be included, with 48 assigned to the intervention group and 48 to the control group. The intervention group will consist of women undergoing repeat cesarean section under spinal anesthesia. During the procedure, participants in the intervention group will watch nature videos with sound through VR glasses. The VR application will be paused when the baby is born to allow for initial neonatal care and skin-to-skin contact. After skin-to-skin contact has been established, the VR application will resume and continue until the completion of the suturing process. Subsequently, once the women are transferred to the ward, the "Personal Information Form," the "Postpartum Comfort Scale," and the "Cesarean Birth Satisfaction Scale for Women Under Spinal Anesthesia," developed by the researcher, will be administered at an appropriate time. This study is expected to support healthcare professionals in integrating VR technology into childbirth practices by providing insights into women's experiences with this intervention. In this way, the study aims to reduce negative emotions experienced during cesarean birth, support the postpartum recovery process, and enhance overall patient satisfaction. Moreover, the findings will contribute to improving the feasibility of digital innovations in healthcare, enhancing the quality of birth experiences, and strengthening the approach to patient-centered care.
- Conditions
- Caesarean Section
- Being tested
- (Intervention Group): Virtual Reality Glasses, Control Group
- Keywords
- caesarean section, virtual reality, cesarean birth satisfaction, postpartum comfort, spinal anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
(Intervention Group): Virtual Reality GlassesDevice
Participants in this group will undergo cesarean section under spinal anesthesia and, during the procedure, will watch immersive nature videos with sound through virtual reality (VR) glasses. The VR application will be paused at the time of birth to allow for initial newborn care and skin-to-skin contact, and then resumed until the completion of suturing. Standard perioperative care will also be provided.
Control GroupOther
Participants in this group will undergo cesarean section under spinal anesthesia and will receive routine perioperative care only, without the use of virtual reality.
| Study group | Role | What they receive |
|---|---|---|
| (Intervention Group): Virtual Reality Glasses | Experimental | Participants in this group will undergo cesarean section under spinal anesthesia and, during the procedure, will watch immersive nature videos with sound through virtual reality (VR) glasses. The VR application will be paused at the time of birth to allow for initial newborn care and skin-to-skin contact, and then resumed until the completion of suturing. In addition to the VR application, all participants will also receive standard perioperative care that is routinely provided to patients undergoing cesarean delivery. Receives: Device: (Intervention Group): Virtual Reality Glasses |
| Control Group | Other | Participants in this group will undergo cesarean section under spinal anesthesia and will receive routine perioperative care only, without the use of virtual reality. Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cesarean Birth Satisfaction
Women's satisfaction with their cesarean delivery experience will be assessed using the researcher-developed "Cesarean Delivery Satisfaction Scale for Women Under Spinal Anesthesia." It will be measured using a researcher-developed 11-item, 5-point Likert-type scale (scores range from 11 to 55), with higher scores indicating greater satisfaction.
Measured: Within 48 hours after cesarean delivery
Secondary outcomes (1)
Postpartum Comfort
Women's postpartum comfort will be measured using the "Postpartum Comfort Scale." It uses a 5-point Likert-type scoring system. The lowest possible score is 34, and the highest is 170. Higher scores indicate greater comfort.
Measured: Within 48 hours after cesarean delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2025
- Study start15 Nov 2025 (estimated)
- Primary completion30 Nov 2025 (estimated)
- Study completion30 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caesarean SectionStudies 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
- None (open label)
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Büşra Küçüktürkmen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Büşra Küçüktürkmen, Bilecik Seyh Edebali Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07247643
- Sponsor's protocol ID
- E-10333602-050.04-280407
- Status last verified
- Nov 2025
- First submitted
- 7 Sep 2025
- Last updated
- 25 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Virtual Reality Glasses on Maternal Satisfaction and Postpartum Comfort in Cesarean Sections Performed Under Spinal Anesthesia
- ClinicalTrials.gov ID
- NCT07247643
- Acronym / sponsor ID
- E-10333602-050.04-280407
- Conditions
- Caesarean Section
- Keywords
- caesarean section, virtual reality, cesarean birth satisfaction, postpartum comfort, spinal anesthesia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Büşra KüçüktürkmenUniversity, hospital or other
- Study start
- 15 Nov 2025 (estimated)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 30 Jan 2026 (estimated)
- First posted
- 25 Nov 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.
Due to the stressful nature of cesarean birth, it is important that the use of virtual reality (VR) glasses is both feasible and effective. While wearing VR glasses, the distraction effect can reduce women's focus on pain and the surgical procedure itself. Furthermore, VR applications have been shown to increase women's satisfaction with the birth experience. This study will be conducted as a randomized controlled trial. A total of 96 participants will be included, with 48 assigned to the intervention group and 48 to the control group. The intervention group will consist of women undergoing repeat cesarean section under spinal anesthesia. During the procedure, participants in the intervention group will watch nature videos with sound through VR glasses. The VR application will be paused when the baby is born to allow for initial neonatal care and skin-to-skin contact. After skin-to-skin contact has been established, the VR application will resume and continue until the completion of the suturing process. Subsequently, once the women are transferred to the ward, the "Personal Information Form," the "Postpartum Comfort Scale," and the "Cesarean Birth Satisfaction Scale for Women Under Spinal Anesthesia," developed by the researcher, will be administered at an appropriate time. This study is expected to support healthcare professionals in integrating VR technology into childbirth practices by providing insights into women's experiences with this intervention. In this way, the study aims to reduce negative emotions experienced during cesarean birth, support the postpartum recovery process, and enhance overall patient satisfaction. Moreover, the findings will contribute to improving the feasibility of digital innovations in healthcare, enhancing the quality of birth experiences, and strengthening the approach to patient-centered care.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| (Intervention Group): Virtual Reality Glasses | Experimental | Device: (Intervention Group): Virtual Reality GlassesParticipants in this group will undergo cesarean section under spinal anesthesia and, during the procedure, will watch immersive nature videos with sound through virtual reality (VR) glasses. The VR application will be paused at the time of birth to allow for initial newborn care and skin-to-skin contact, and then resumed until the completion of suturing. In addition to the VR application, all participants will also receive standard perioperative care that is routinely provided to patients undergoing cesarean delivery. |
| Control Group | Other | Other: Control GroupParticipants in this group will undergo cesarean section under spinal anesthesia and will receive routine perioperative care only, without the use of virtual reality. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Women aged 18-45 years
- Undergoing elective repeat cesarean section under spinal anesthesia
- Able to communicate in Turkish and provide informed consent
- Singleton pregnancy
Key exclusion criteria (5 listed)
- Presence of obstetric or medical complications requiring general anesthesia
- Emergency cesarean sections
- Psychiatric or neurological disorders that may interfere with VR use
- Contraindications to spinal anesthesia
- Visual or hearing impairments preventing effective use of VR glasses
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 |
|---|---|---|
| (Intervention Group): Virtual Reality GlassesParticipants in this group will undergo cesarean section under spinal anesthesia and, during the procedure, will watch immersive nature videos with sound through virtual reality (VR) glasses. The VR application will be paused at the time of birth to allow for initial newborn care and skin-to-skin contact, and then resumed until the completion of suturing. Standard perioperative care will also be provided. | Device | (Intervention Group): Virtual Reality Glasses |
| Control GroupParticipants in this group will undergo cesarean section under spinal anesthesia and will receive routine perioperative care only, without the use of virtual reality. | Other | Control Group |
Primary outcome
Cesarean Birth Satisfaction
Time frame: Within 48 hours after cesarean delivery
Women's satisfaction with their cesarean delivery experience will be assessed using the researcher-developed "Cesarean Delivery Satisfaction Scale for Women Under Spinal Anesthesia." It will be measured using a researcher-developed 11-item, 5-point Likert-type scale (scores range from 11 to 55), with higher scores indicating greater satisfaction.
1 secondary outcome
Postpartum Comfort
Time frame: Within 48 hours after cesarean delivery
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 25 Nov 2025.
Related trials for Caesarean Section
Not yet recruiting
Comparison of Effect of Two Different Doses of Intravenous Oxytocin on Patients Undergoing Elective Cesarean Section
Postpartum Hemorrhage, Uterine Atony
Not yet recruitingObservational study
Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
Gestational Diabetes Mellitus (GDM), Obstetric Anesthesia
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
Active, not recruiting
Implementation of a Disparities in Labor Outcomes Dashboard
Labor Induction, Cesarean Birth
RecruitingPhase 1
Ketamine Pharmacokinetics and Pharmacodynamics for Postpartum Depression and Pain After Cesarean Delivery
Pain, Postpartum Depression
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing (Intervention Group): Virtual Reality Glasses in people with Caesarean Section, run by Büşra Küçüktürkmen.
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 4 inclusion and 5 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: opening soon, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
Cesarean Birth Satisfaction (time frame: Within 48 hours after cesarean delivery). 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 25 Nov 2025.