- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07541508
Evaluation Of Stress Levels Of Pediatric Dentist Performing Dental Treatment In The Operating Room
Evaluation Of Stress Levels Of A Group Of Pediatric Dentist During Laryngeal Mask, Deep Sedation And General Anesthesia Procedures
Study Overview
Status
Conditions
Detailed Description
The aim of this study is to determine the stress levels of pediatric dentists during dental treatment procedures using different airway devices (nasal mask, laryngeal mask (LMA), intubation tube) in the operating room environment and to examine the changes according to the methods.
Three female dentists with at least 10 years of experience, systemically healthy, and similar age, height, and weight, working at the Pediatric Dentistry Clinic of Erciyes University Faculty of Dentistry participated in this study. Each dentist treated 42 patients, 14 each, using nasal mask, laryngeal mask and general anesthesia methods. A total of 126 patients were treated in the operating room. Vital signs (systolic blood pressure, diastolic blood pressure, pulse, oxygen saturation) were measured three times by physicians, 10 minutes before starting the treatment, 25 minutes after the treatment, and 10 minutes after the treatment ended, and saliva samples were taken.
All measurements were made between 9:00 and 12:00 a.m. salivary cortisol was measured by electrochemiluminescence (ECLIA) method using the Roche Cortisol II kit and the Roche Cobas e 801 analyzer. Salivary alpha amylase was measured by colorimetric enzyme test using Roche Cobas c 701 analyzer. Physicians' stress was assessed using VAS (Visual Analog Scale), one of the psychogenic methods.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Melikgazi
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Kayseri, Melikgazi, Turkey (Türkiye), 38039
- Erciyes University Faculty of Dentistry, Department of Pediatric Dentistry
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Body mass index (BMI) of 25 kg/m² and less
- Systemically healthy
- Without a diagnosed stress-anxiety disorder or depression
- Having worked with pediatric patients in an operating room environment for at least 10 years.
- Responding to chronic occupational stress questions similar to the Dentist Job Stress Questionnaire (DJS).
- Female pediatric dentist
Exclusion Criteria:
- pregnant women
- breastfeeding mothers
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Deep sedation with nasal mask
Three pediatric dentists each treated 14 patients under deep sedation with a nasal mask.
The dentists' stress levels were measured throughout the treatments.
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Deep sedation with laryngeal mask
Three pediatric dentists each treated 14 patients under deep sedation using a laryngeal mask.
The dentists' stress levels were measured throughout the treatments.
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general anesthesia
Three pediatric dentists each treated 14 patients under general anesthesia.
The dentists' stress levels were measured throughout the treatment.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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salivary alpha amylase
Time Frame: Measurements were taken three times: 10 minutes before each treatment, 25 minutes after treatment begins, and 10 minutes after the treatment.
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Alpha amylase levels were measured in saliva samples taken from pediatric dentists.
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Measurements were taken three times: 10 minutes before each treatment, 25 minutes after treatment begins, and 10 minutes after the treatment.
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salivary cortisol
Time Frame: Measurements were taken three times: 10 minutes before each treatment, 25 minutes after treatment begins, and 10 minutes after the treatment.
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Cortisol levels were measured in saliva samples taken from pediatric dentists.
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Measurements were taken three times: 10 minutes before each treatment, 25 minutes after treatment begins, and 10 minutes after the treatment.
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systolic and diastolic blood pressure
Time Frame: Measurements were taken three times: 10 minutes before each treatment, 25 minutes after treatment begins, and 10 minutes after the treatment.
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Systolic and diastolic blood pressure was measured in pediatric dentists.
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Measurements were taken three times: 10 minutes before each treatment, 25 minutes after treatment begins, and 10 minutes after the treatment.
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pulse
Time Frame: Measurements were taken three times: 10 minutes before each treatment, 25 minutes after treatment begins, and 10 minutes after the treatment.
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The pulse of pediatric dentists was taken.
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Measurements were taken three times: 10 minutes before each treatment, 25 minutes after treatment begins, and 10 minutes after the treatment.
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oxygen saturation
Time Frame: Measurements were taken three times: 10 minutes before each treatment, 25 minutes after treatment begins, and 10 minutes after the treatment.
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Oxygen saturation was measured in pediatric dentists.
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Measurements were taken three times: 10 minutes before each treatment, 25 minutes after treatment begins, and 10 minutes after the treatment.
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Visual Analog Scale (VAS) score
Time Frame: Each physician conducted an evaluation at the end of each treatment session.
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Physicians used the Visual Analog Scale to indicate stress levels after each treatment.This scale is scored from 0 to 10.
A score of 0 means "no stress".
A score of 10 describes the "maximum stress" level.
Higher scores on this scale indicate increasing stress levels.
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Each physician conducted an evaluation at the end of each treatment session.
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Esra Kızılcı, Erciyes Üniversitesi Diş Hekimliği Fakültesi
Publications and helpful links
General Publications
- Hellhammer DH, Wust S, Kudielka BM. Salivary cortisol as a biomarker in stress research. Psychoneuroendocrinology. 2009 Feb;34(2):163-171. doi: 10.1016/j.psyneuen.2008.10.026. Epub 2008 Dec 18.
- Lesage FX, Berjot S. Validity of occupational stress assessment using a visual analogue scale. Occupational medicine (Oxford, England). 2011;61(6):434-6.
- Nater UM, Rohleder N. Salivary alpha-amylase as a non-invasive biomarker for the sympathetic nervous system: current state of research. Psychoneuroendocrinology. 2009;34(4):486-96.
- Lovallo WR, Buchanan TW. Stress hormones in psychophysiological research: emotional, behavioral, and cognitive implications. 2017.
- Özmert S. Derin Sedasyon Altında Dental Tedavi Uygulanan Çocuklarda Anestezik Yaklaşımın Değerlendirilmesi. Turkish Journal of Pediatric Disease. 2019;13(1):30-5.
- Meadows JL, Shah S, Burg MM, Pfau S, Soufer R. Cardiovascular Imaging of Biology and Emotion: Considerations Toward a New Paradigm. Circulation Cardiovascular imaging. 2020;13(8):e011054.
- Giacomello G, Scholten A, Parr MK. Current methods for stress marker detection in saliva. Journal of pharmaceutical and biomedical analysis. 2020;191:113604.
- Chojnowska S, Ptaszyńska-Sarosiek I, Kępka A, Knaś M, Waszkiewicz N. Salivary Biomarkers of Stress, Anxiety and Depression. Journal of clinical medicine. 2021;10(3).
- Song KW, Kim HK. Job stress and its related factors among Korean dentists: An online survey study. International dental journal. 2019;69(6):436-44.
- Kızılcı E, Kızılay F, Mahyaddinova T, Muhtaroğlu S, Kolçakoğlu K. Stress levels of a group of dentists while providing dental care under clinical, deep sedation, and general anesthesia. Clinical oral investigations. 2023;27(7):3601-9.
- Anabuki AA, Corrêa-Faria P, Batista AC, Costa LR. Paediatric dentists' stress during dental care for children under sedation: a cross-sectional study. European archives of paediatric dentistry : official journal of the European Academy of Paediatric Dentistry. 2021;22(2):301-6.
- Humphris G. A review of burnout in dentists. Dental update. 1998;25(9):392-6.
- Dewa CS, Lin E, Kooehoorn M, Goldner E. Association of chronic work stress, psychiatric disorders, and chronic physical conditions with disability among workers. Psychiatric services (Washington, DC). 2007;58(5):652-8.
- Davidovich E, Pessov Y, Baniel A, Ram D. Levels of Stress among General Practitioners, Students and Specialists In Pediatric Dentistry during Dental Treatment. The Journal of clinical pediatric dentistry. 2015;39(5):419-22.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- EU-DHF-MK-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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