Skip to main content
OpenTrials
Completed

NCT Number: NCT04689373

Physical and Cognitive Effects of Fluoroscopy

Background and objectives:

The researchers will perform this study to reveal the clinical meaning of fatigue, headache, diarrhea, and impaired cognitive functions that are often expressed verbally in healthcare professionals who are exposed to fluoroscopy.

Methods:

After obtaining written informed consent, 84 samples will be included in the study. For operating room employees who meet the criteria determined before and after the operation; mini-mental state examination, weight, heart rate, non-invasive blood pressure value, VAS score for headache, radiation exposure time on fluoroscopy device, Rad measurement with the help of personal dosimeter before and after surgery, and total time in the operating room will be recorded.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Istanbul University, Faculty of Medicine

Istanbul, Fatih, 34093, Turkey (Türkiye)

About this study

Background and objectives:

Nowadays, operations under fluoroscopy are performed at increasing rates with the aim of increasing case management and surgical success. Due to this increasing exposure to radiation, it is important to show that fluoroscopy has an impact on employees not only annually but also daily. The researchers will perform this study to reveal the clinical meaning of fatigue, headache, diarrhea, and impaired cognitive functions that are often expressed verbally in healthcare workers who are exposed to fluoroscopy.

Methods:

After obtaining written informed consent; 84 samples consisting of orthopedic surgery and anesthesia residents and orthopedic operating room nurses between the ages of 18-60 who do not have cardiological, neurological and psychiatric diseases, have had fluoroscopic operations lasting more than 2 hours, wear protective scopy gowns and collar during surgery, will be included in the study. The total number of samples required for the study will be reached by taking repeated measurements on consecutive days from the same sample group, but not on the same day. For operating room employees who meet the criteria determined before and after the operation; mini-mental state examination, weight, heart rate, non-invasive blood pressure value, VAS score for headache, radiation exposure time on fluoroscopy device, Rad measurement with the help of personal dosimeter before and after surgery, and total time in the operating room will be recorded. This prospective study will be executed between December 2020 and June 2021.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Volunteering to participate in the study
  • ASA classification 1 or 2
  • Not leaving the operating room during the operation
  • To be carrying a fluoroscopy gown, protective collar, and dosimeter.

Exclusion criteria

  • Having a psychiatric illness
  • Having a neurological disease
  • Being under the age of 18
  • Presence of cardiac pathology
  • Being pregnant or suspected of pregnancy

Treatment and study plan

VAS Score

Diagnostic Test

The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain.

The Mini-Mental State Exam (MMSE) is a widely used test of cognitive function among the elderly; it includes tests of orientation, attention, memory, language and visual-spatial skills.

Other names: Mini Mental State Examination

Primary outcomes

  1. Heart Rate

    Time frame: In the perioperative period

    Pulse oximeter

  2. Non Invasive Blood Pressure

    Time frame: In the perioperative period

    Syphgmomanometer

  3. Weight

    Time frame: In the perioperative period

    Weighing machine

Secondary outcomes

  1. Diarrhea

    Time frame: 2 hours after surgery

    Verbal answers

  2. Visual Analog Scale (VAS) Score

    Time frame: 15 minutes after surgery

    VAS Score Scale (Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain(0 mm)" and "worst pain(100mm)".)

  3. Radiation Exposure Time on Fluoroscopy Device

    Time frame: During surgery

    Chronometer

  4. Rad Measurement

    Time frame: 5 minutes after surgery

    Personal Dosimeter

  5. Total Time in the Operating Room

    Time frame: During surgery

    Chronometer

  6. Mini Mental State Examination

    Time frame: 15 minutes after surgery

    Mini Mental State Examination Scale (This scale is a 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment. Any score of 24 or more (out of 30) indicates a normal cognition. Below this, scores can indicate severe (≤9 points), moderate (10-18 points) or mild (19-23 points) cognitive impairment.)

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Registry information

Official study title

Physical and Cognitive Effects of Fluoroscopy on Medical Professionals in the Operating Room : A Prospective Observational Study

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 30, 2020
Registry last updated
Feb 1, 2022

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.

Published trials that share one or more normalized conditions with this study.