Virtual Reality-Assisted Intraoperative Sensory Modulation on Postpartum Depression and the Kynurenine Pathway

NCT07300176 | Active Not Recruiting

• 1 other identifier: tufantez2025
• Study Type: observational
• Target: 98
• Locations: 1 country
• Sites: 1

Brief Summary

The research will be conducted as a prospective, observational, and comparative study with 98 pregnant volunteers aged 18-45 at Düzce University Faculty of Medicine. Participants will be divided into a VR group and a control group. Data will be collected using STAI-I, EPDS, NRS scales, and biochemical analyses (tryptophan, kynurenine, etc.). Upon completion, the project is expected to contribute to non-pharmacological approaches and new care protocols for reducing postpartum depression.

Conditions

Virtual Reality; Kynurenine Pathway and Its Metabolites; Pregnancy; Satisfaction; Postpartum Depression (PPD)

Keywords

Postpartum Depression; Kynurenine Pathway; Cesarean Section; Sensory Modulation; Virtual Reality

Outcome Measures

Primary Outcomes (2)

• Change in Edinburgh Postnatal Depression Scale (EPDS)

  The Edinburgh Postnatal Depression Scale (EPDS) will assess depressive symptoms related to the peripartum period. Measurements will be obtained preoperatively and after the intraoperative VR application. Changes in EPDS scores (numbers 0-30 ) will help determine whether VR reduces depressive affect during the surgical experience.

  up to 6 weeks

• Change in State-Trait Anxiety Inventory-State (STAI-I) score

  The State-Trait Anxiety Inventory-State (STAI-I) score ( number 16-80) will be used to assess changes in acute anxiety levels in pregnant patients undergoing cesarean section under spinal anesthesia. Scores will be recorded immediately before the intraoperative VR intervention and again during the procedure. A reduction in STAI-I score following VR exposure will indicate decreased anxiety.

  up to 6 weeks

Secondary Outcomes (2)

• Biochemical Levels of Kynurenine Pathway Metabolites

  up to 6 weeks

• Patient Satisfaction Numerical Rating Scale score

  up to 6 weeks

Study Arms (2)

Group 1 (VR group, n = 49):

Patients who underwent cesarean section under spinal anesthesia and received intraoperative virtual reality (VR) intervention via a VR headset to provide sensory modulation.

Group 2 (Control group, n = 49)

Patients who underwent cesarean section under spinal anesthesia and received standard clinical care without any VR application

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of pregnant women scheduled for elective cesarean section under spinal anesthesia. Participants will be recruited from the obstetrics and gynecology department of the participating hospital. Eligible individuals must be between 18 and 45 years of age, carrying a singleton pregnancy, clinically stable for regional anesthesia and accepted for VR equipment usage during operation.

You may qualify if:

• Pregnant women scheduled for elective cesarean section
• Age between 18 and 45 years
• ASA physical status I-II
• No contraindication to spinal anesthesia
• Accepted for VR equipment usage during operation.
• Signed written informed consent

You may not qualify if:

• Anticipated need for postoperative intensive care unit (ICU) admission
• History of psychiatric or neurological disease
• Visual or auditory impairment
• Severe preeclampsia, eclampsia, or HELLP syndrome
• Perinatal loss (postpartum neonatal death)
• History of convulsions or epilepsy

Sponsors & Collaborators

• Duzce University: lead

Study Sites (1)

Duzce University

Düzce, 81620, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Depression, Postpartum; Personal Satisfaction

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders; Behavior

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Weeks
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2025
• First Posted: December 23, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: December 23, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 10/12/2025 (start date) 10/12/2030 (end date)
• Access Criteria: All the people

Locations

TU (1)