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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT20260210068821N1

Enrollment

Registered

2026-02-18

Start date

2026-04-08

Completion date

Unknown

Last updated

2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Incidence and Severity of Shivering and Nausea in Cesarean Section.

Interventions

Intervention 1: Intervention group: the pharmacological interventions group (ondansetron + pethidine combination). Intervention 2: Control group: the non-pharmacological interventions group.

Eligibility

Sex/Gender

Female

Age

18 Years to 45 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactALI KHALAFI

Ahvaz University of Medical Sciences

khalafi.a2006@gmail.com+98 916 335 9407

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Jun 11, 2026