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NCT05481255 Clinical Trial

Association With Spinal Needle-puncture Pain and Menstrual Phase

Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05481255
Other study ID # spinal needle-puncture pain
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 2, 2022
Est. completion date May 17, 2023

Study information
Verified date May 2023
Source Konya Meram State Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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).

Recruitment information / eligibility
Status Completed
Enrollment 80
Est. completion date May 17, 2023
Est. primary completion date May 17, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 40 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Turkey Konya Education and Training Hospital Konya

Sponsors (1)
Lead Sponsor Collaborator
Konya Meram State Hospital

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary spinal needle-puncture pain 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). 10 minutes
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