NCT05481255

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 27, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 1, 2022

Completed
1 day until next milestone

Study Start

First participant enrolled

August 2, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 17, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 17, 2023

Completed
Last Updated

May 18, 2023

Status Verified

May 1, 2023

Enrollment Period

10 months

First QC Date

July 27, 2022

Last Update Submit

May 17, 2023

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsonly female patients will be involved with regular and active menstrual cycles
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

80 female patients who are of reproductive age and have had a regular menstrual cycle for at least six months

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Konya Education and Training Hospital

Konya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ass.Prof.

Study Record Dates

First Submitted

July 27, 2022

First Posted

August 1, 2022

Study Start

August 2, 2022

Primary Completion

May 17, 2023

Study Completion

May 17, 2023

Last Updated

May 18, 2023

Record last verified: 2023-05

Locations

TU(1)