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Clinical Trials/NCT05481255
NCT05481255
Completed
Not Applicable

Does the Menstrual Phase Affect Skin Puncture Pain During Spinal Anesthesia? Prospective, Observational Study

Konya Meram State Hospital1 site in 1 country80 target enrollmentAugust 2, 2022
ConditionsPain

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pain
Sponsor
Konya Meram State Hospital
Enrollment
80
Locations
1
Primary Endpoint
spinal needle-puncture pain
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

This prospective observational study aimed to evaluate the relationship between menstrual phase cycles and spinal needle-puncture pain during spinal anesthesia in female patients of reproductive age.

Detailed Description

Before the spinal anesthesia procedure, the anxiety and depression levels of the patients will be evaluated with the 14-scale 'hospital anxiety and depression scale.' The spinal anesthesia procedure will be performed by the anesthesiologist responsible for the patient. At the end of the spinal anesthesia procedure, a researcher with no knowledge of the patient's menstrual phase information will ask rate the spinal needle-puncture pain felt during spinal anesthesia with a numerical rating scale (NRS), which is graded from 1 to 10 (0: no pain, 10: very severe pain).

Registry
clinicaltrials.gov
Start Date
August 2, 2022
End Date
May 17, 2023
Last Updated
2 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Betul Kozanhan

Ass.Prof.

Konya Meram State Hospital

Eligibility Criteria

Inclusion Criteria

  • Female volunteers of reproductive age have had a regular menstrual cycle for at least six months

Exclusion Criteria

  • Pregnancy
  • ASA physical status III and IV
  • Patients with psychiatric disorders,
  • Emergency surgeries
  • Mentally retarded patients,
  • Patients with multiple spinal anesthesia trials
  • Patients with previous spinal surgery experience

Outcomes

Primary Outcomes

spinal needle-puncture pain

Time Frame: 10 minutes

A numerical rating scale (NRS) will be used to assess spinal needle-puncture pain during spinal anesthesia, graded from 1 to 10 (0: no pain, 10: very severe pain).

Study Sites (1)

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