An interventional study of Virtual Reality Distraction in Anxiety, Cesarean Section and Birth Satisfaction, sponsored by Tarsus University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-02.
Sponsored by Tarsus University · Not applicable, Interventional, and Supportive care
This study will examine whether virtual reality during planned cesarean birth reduces women's anxiety and improves their satisfaction with the birth experience.
The study will include 144 women undergoing elective cesarean section under spinal anesthesia at Adana City Training and Research Hospital in Türkiye. Participants will be randomly assigned to one of two groups. One group will receive routine care and watch a relaxing nature video with natural sounds through a virtual reality headset during surgery. The other group will receive routine care alone.
Virtual reality will be paused when the baby is born so that anxiety can be assessed and the mother can see her baby. It will then resume until surgery ends.
Anxiety and vital signs will be assessed before surgery and 15-30 minutes after completion of surgery, once the participant is clinically stable. An additional brief anxiety assessment will be performed immediately after birth, before the mother first sees her baby. Satisfaction with cesarean birth will be assessed 6-8 hours after birth.
The researchers will compare the results between the two groups to evaluate the effects of virtual reality on maternal anxiety and cesarean birth satisfaction.
This single-center, two-arm, parallel-group randomized controlled trial will evaluate an intraoperative virtual reality intervention in women undergoing elective cesarean section under spinal anesthesia. The planned sample is 144 women, with 72 participants assigned to each group.
Randomization and Allocation Concealment A computer-generated randomization sequence with a 1:1 allocation ratio and variable block sizes of four and six has been generated using Sealed Envelope. The sequence will be held by an independent person who is not involved in participant recruitment or intervention delivery. Sequentially numbered, opaque, sealed envelopes will be prepared before recruitment. After eligibility confirmation, written informed consent, and baseline assessments, the next envelope in numerical order will be opened to determine group assignment.
Intervention Virtual reality will begin after the effectiveness of spinal anesthesia has been confirmed. Participants will view the same standardized 360-degree nature video featuring forest, water, and wildlife scenes with natural sounds, without speech or guided meditation. The video lasts approximately 20-30 minutes and will be restarted if necessary.
At the baby's birth, virtual reality will be paused. The Face Anxiety Scale will be administered immediately after birth and before the mother's first meeting with her baby. After this assessment, routine newborn care and the mother's opportunity to see her baby will take place. Virtual reality will then resume until the end of surgery.
The control group will receive routine care alone, with assessments at the same time points.
Assessments State anxiety will be assessed using the State-Trait Anxiety Inventory, State Subscale (STAI-I), before surgery (prior to randomization) and 15-30 minutes after completion of surgery, once the participant is clinically stable.
The Face Anxiety Scale will be administered at three time points: before surgery (prior to randomization), immediately after birth and before the mother's first meeting with her baby, and 15-30 minutes after completion of surgery, once clinically stable.
Systolic and diastolic blood pressure, heart rate, respiratory rate, and peripheral oxygen saturation will be recorded before surgery (prior to randomization) and 15-30 minutes after completion of surgery, once the participant is clinically stable.
Cesarean birth satisfaction will be assessed 6-8 hours postpartum using the Cesarean Birth Satisfaction Scale.
Masking Participants and the researcher delivering the intervention cannot be blinded. Data entry will be performed by an independent researcher unaware of group assignments, using groups coded as A and B. Statistical analyses will be conducted by a statistician unaware of which intervention each code represents. Group identities will be disclosed after the analyses are completed.
Statistical Analysis Data will be analyzed using appropriate statistical methods according to the measurement level and distribution of each outcome. The primary outcome, postoperative state anxiety, will be compared between groups with adjustment for baseline anxiety scores. Repeated measurements of Face Anxiety Scale scores will be analyzed using methods appropriate for ordinal longitudinal data. Vital signs will be compared between groups with adjustment for baseline measurements. Cesarean birth satisfaction scores will be compared between groups using appropriate statistical tests. Results will be reported with 95% confidence intervals and relevant effect size estimates. Statistical significance will be set at p \< 0.05. Missing data will be assessed and reported.
5,113 studies on the registry are indexed under Anxiety Disorders; 1,418 are open to participants now.
This study's planned enrollment of 144 is above the median of 80 across 4,380 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →Tarsus University is the lead sponsor of 82 studies on the registry; 30 are open to participants now.
Compared within Anxiety Disorders, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →
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Exclusion Criteria:
Participants will receive intraoperative virtual reality in addition to routine care during elective cesarean section under spinal anesthesia. After effective spinal anesthesia is confirmed, a standardized 360-degree nature video with natural sounds will be presented through a virtual reality headset. The intervention will be paused at birth for the Face Anxiety Scale assessment and the mother's first meeting with her baby, then resumed until surgery ends.
Device: Virtual Reality Distraction
Participants will receive routine care during elective cesarean section under spinal anesthesia, without virtual reality or any additional study intervention. Assessments will be performed at the same time points as in the experimental group.
Participants in the intervention group will receive a standardized immersive virtual reality (VR) session via a head-mounted display with headphones during elective cesarean section under spinal anesthesia, in addition to routine care. The VR headset will be applied after adequate spinal block is confirmed. Content is a 360-degree nature video (forest, water and wildlife scenes) with natural sounds, without speech or guided meditation, lasting about 20-30 minutes and restarted if surgery lasts longer. VR will be paused at the birth of the baby for the intraoperative Face Anxiety Scale assessment and the first mother-infant contact, then resumed until the end of surgery. Volume and fit will be adjusted for comfort. VR will be stopped immediately if dizziness, nausea, headache or other discomfort occurs, or if clinically required.
State Anxiety
State anxiety will be assessed using the State-Trait Anxiety Inventory - State Subscale (STAI-I), Turkish version. Scores range from 20 to 80; higher scores indicate higher anxiety levels.
Time frame: Preoperatively (before randomization) and 15-30 minutes after completion of surgery, once clinically stable
Face Anxiety Score
Momentary anxiety will be assessed using the single-item Face Anxiety Scale (Turkish version). Scores range from 1 to 5; higher scores indicate higher anxiety.
Time frame: Preoperatively (before randomization), intraoperatively (immediately after birth, before first mother-infant contact), and 15-30 minutes after completion of surgery, once clinically stable
Cesarean Birth Satisfaction
Cesarean birth satisfaction will be assessed using the 11-item Cesarean Birth Satisfaction Scale. Scores range from 11 to 55; higher scores indicate greater satisfaction.
Time frame: 6-8 hours postpartum
Systolic Blood Pressure
Systolic blood pressure (mmHg) will be measured and recorded on the Vital Signs Monitoring Form.
Time frame: Preoperatively (before randomization) and 15-30 minutes after completion of surgery, once clinically stable
Diastolic Blood Pressure
Diastolic blood pressure (mmHg) will be measured and recorded on the Vital Signs Monitoring Form.
Time frame: Preoperatively (before randomization) and 15-30 minutes after completion of surgery, once clinically stable
Heart Rate
Heart rate (beats per minute) will be measured and recorded on the Vital Signs Monitoring Form.
Time frame: Preoperatively (before randomization) and 15-30 minutes after completion of surgery, once clinically stable
Respiratory Rate
Respiratory rate (breaths per minute) will be measured and recorded on the Vital Signs Monitoring Form.
Time frame: Preoperatively (before randomization) and 15-30 minutes after completion of surgery, once clinically stable
Peripheral Oxygen Saturation (SpO₂)
Peripheral oxygen saturation (%) will be measured by pulse oximetry and recorded on the Vital Signs Monitoring Form.
Time frame: Preoperatively (before randomization) and 15-30 minutes after completion of surgery, once clinically stable
Plan to share: No — Individual participant data will not be shared publicly in order to protect participant confidentiality, in accordance with the Turkish Personal Data Protection Law (KVKK, No. 6698) and the informed consent obtained, which does not include permission for data sharing with third parties. Aggregated results will be reported in the thesis and in peer-reviewed publications.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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