NCT07247643

Brief 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. 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2025

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 7, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

November 15, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 25, 2025

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2026

Completed
Last Updated

November 25, 2025

Status Verified

November 1, 2025

Enrollment Period

15 days

First QC Date

September 7, 2025

Last Update Submit

November 22, 2025

Conditions

Keywords

caesarean sectionvirtual realitycesarean birth satisfactionpostpartum comfortspinal anesthesia

Outcome Measures

Primary Outcomes (1)

  • 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.

    Within 48 hours after cesarean delivery

Secondary Outcomes (1)

  • Postpartum Comfort

    Within 48 hours after cesarean delivery

Study Arms (2)

(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.

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.

Other: Control Group

Interventions

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.

(Intervention Group): Virtual Reality Glasses

Participants in this group will undergo cesarean section under spinal anesthesia and will receive routine perioperative care only, without the use of virtual reality.

Control Group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Women aged 18-45 years
  • Undergoing elective repeat cesarean section under spinal anesthesia
  • Able to communicate in Turkish and provide informed consent
  • Singleton pregnancy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research Assistant, Department of Midwifery

Study Record Dates

First Submitted

September 7, 2025

First Posted

November 25, 2025

Study Start

November 15, 2025

Primary Completion

November 30, 2025

Study Completion

January 30, 2026

Last Updated

November 25, 2025

Record last verified: 2025-11