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Completed

NCT Number: NCT05481255

Association With Spinal Needle-puncture Pain and Menstrual Phase

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.

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

Konya Education and Training Hospital

Konya, Turkey (Türkiye)

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

Konya Meram State Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 1, 2022
Registry last updated
May 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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