Virtual Reality for Anxiety and Birth Satisfaction During Elective Cesarean Section

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.