- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07247643
The Impact of Virtual Reality Glasses on Maternal Satisfaction and Postpartum Comfort in Cesarean Sections Performed Under Spinal Anesthesia
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Women aged 18-45 years
Undergoing elective repeat cesarean section under spinal anesthesia
Able to communicate in Turkish and provide informed consent
Singleton pregnancy
Exclusion Criteria:
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: (Intervention Group): Virtual Reality Glasses
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.
|
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.
|
|
Other: Control Group
Participants in this group will undergo cesarean section under spinal anesthesia and will receive routine perioperative care only, without the use of virtual reality.
|
Participants in this group will undergo cesarean section under spinal anesthesia and will receive routine perioperative care only, without the use of virtual reality.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Within 48 hours after cesarean delivery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postpartum Comfort
Time Frame: Within 48 hours after cesarean delivery
|
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.
|
Within 48 hours after cesarean delivery
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- E-10333602-050.04-280407
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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