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IRCT20260210068821N1 IRCT 2026-02-18 Ahvaz University of Medical Sciences Non-Drug Methods vs. Drug Combination for Shivering and Nausea after Spinal Anesthesia in Cesarean Section Comparison of the Effect of Non-Pharmacological Interventions Versus a Combination of Ondansetron and Pethidine on Shivering, Nausea, and Vomiting after Spinal Anesthesia for Cesarean Section 2026-04-08 anticipated 40 Complete https://irct.ir/trial/89051 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In the present study, participants will be allocated to the two intervention groups (non-pharmacological and pharmacological) using block randomization with variable block sizes (4 and 6) via sequentially numbered, sealed, opaque envelopes, Blinding description: This study will employ a single-blind design. In this design, participants (patients) will be aware of their group allocation due to the tangible nature of the interventions. However, outcome assessors and data analysts will remain blinded to group assignment until the completion of the primary analysis. The principal investigator responsible for administering the interventions and initial data recording will not be blinded due to the practical nature of the interventions. N/A Incidence and Severity of Shivering and Nausea in Cesarean Section. Intervention 1: Intervention group: the pharmacological interventions group (ondansetron + pethidine combination). Intervention 2: Control group: the non-pharmacological interventions group. Yes - There is a plan to make this available What will be shared: De-identified individual participant data. This set includes all raw data collected per protocol: baseline demographics, primary outcomes (incidence and severity of shivering, incidence of nausea and vomiting), secondary outcomes (vital signs), and safety data. Data will be shared in a structured Excel or CSV file after removal of all direct identifiers (name, medical record number, phone number) and coding. When: Data will become publicly available 12 months after the publication of the primary study results in a peer-reviewed journal and will remain accessible for at least 5 years thereafter. To whom: Access is open to academic researchers and scientists affiliated with credible research or educational institutions, for the purpose of conducting valid scientific secondary analyses or meta-analyses. Conditions: Data may only be used for non-commercial research purposes with proper citation of the original study. Requestors must submit a brief scientific analysis proposal (max 1 page) outlining the aims, methods, and intended outputs of the secondary analysis. Use for validation of findings or educational purposes is permitted. Where to obtain: Requests should be submitted via email to the study's corresponding researcher: Title: Assistant/Associate Professor of Anesthesiology Affiliation: Ahvaz Jundishapur University of Medical Sciences How to obtain: Upon receipt of a formal request and analysis proposal, the Study Data Access Committee will review the request for alignment with the stated purposes and conditions within 4 weeks and communicate its decision via email. If approved, data will be shared within 2 weeks after receiving a signed data use agreement. Comments:
public ALI KHALAFI
Ahvaz, golestan
Ahvaz Iran (Islamic Republic of) 1111111111 +98 916 335 9407 khalafi.a2006@gmail.com Ahvaz University of Medical Sciences scientific ALI KHALAFI
Ahvaz, golestan
Ahvaz Iran (Islamic Republic of) 111111111 +98 916 335 9407 khalafi.a2006@gmail.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) Women aged 18 to 45 years candidates for elective cesarean section under spinal anesthesia ASA physical status class I or II gestational age ≥37 weeks provision of written informed consent 18 years 45 years Female Treatment - Drugs Treatment - Drugs Intervention group: the pharmacological interventions group (ondansetron + pethidine combination). Control group: the non-pharmacological interventions group Incidence of shivering, defined as the presence or absence (yes/no) of at least one episode of involuntary and observable shivering; severity of shivering, measured using the Wrench Shivering Grading Scale (0 to 3); and incidence of nausea, defined as patient-reported subjective feeling of the need to vomit (yes/no). All outcomes are assessed from the start of the intervention until 60 minutes (for shivering) and 6 hours (for nausea) after the completion of the cesarean section. Timepoint: Shivering outcomes are monitored continuously up to 60 minutes postoperatively, and nausea is assessed at three time points: at the end of the surgery, and at 2 hours and 6 hours after surgery. Method of measurement: check list. Ahvaz University of Medical Sciences Approved 2026-02-13 Ethics committee of Ahvaz Jundishapur University of Medical Sciences Esfand Ahvaz Khouzestan Iran (Islamic Republic of)