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The Impact of a Shared Decision-Making Intervention on Intraoperative Patient Experience During Elective Cesarean Delivery Under Spinal Anesthesia
Sponsor: Alexandria University
Summary
Caesarean delivery (CD) is a common surgical procedure performed when vaginal delivery poses risks to the mother or fetus, with global rates projected to reach 28.5% by 2030. Neuraxial anesthesia is the preferred technique due to its safety advantages over general anesthesia, which is associated with increased risks such as impaired oxygenation, aspiration, and higher incidence of postpartum depression. Although spinal anesthesia is widely used, it may be complicated by intraoperative pain during cesarean delivery (PDCD), attributed to visceral traction despite adequate sensory block . PDCD is associated with adverse psychological outcomes including anxiety, postpartum depression, and post-traumatic stress disorder , and is the leading cause of obstetric anesthesia-related medicolegal claims in the United Kingdom . Reported incidence rates vary widely, from 2.1% to 36%, reflecting under-recognition and misinterpretation by clinicians who may mistake pain for anxiety . Shared decision-making (SDM) is a patient-centered approach that incorporates patient preferences into perioperative planning and has been shown to improve outcomes in various surgical settings , yet its impact on intraoperative experience during cesarean delivery remains unexplored.
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
80
Start Date
2026-04-01
Completion Date
2027-10-01
Last Updated
2026-03-17
Healthy Volunteers
No
Conditions
Interventions
Proactive Plan: prophylactic IV ketamine 0.2 mg/kg or IV midazolam 1 mg given prior to incision. Reactive Plan: no prophylactic medication; rescue IV fentanyl 50 mcg administered only if NRS ≥4.
Proactive Plan: prophylactic IV ketamine 0.2 mg/kg or IV midazolam 1 mg given prior to incision. Reactive Plan: no prophylactic medication; rescue IV fentanyl 50 mcg administered only if NRS ≥4. Proactive: administer the chosen medication prior to skin incision. Reactive: administer rescue analgesia only if pain is reported.
Control Group (Standard Care)
Patients will receive standard preoperative counseling delivered by the anesthesiologist using the institutional script. No structured shared decision-making process or documented preference for intraoperative analgesic management will be included.
Locations (1)
medical research institute , Alexandrria university
Alexandria, Egypt