StressNCT07541508
Evaluation Of Stress Levels Of Pediatric Dentist Performing Dental Treatment In The Operating Room
An observational study of Stress, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial summary
This study will measure the stress levels of pediatric dentists performing dental treatments under deep sedation and general anesthesia. Stress levels will be compared during sedation and general anesthesia procedures performed using three different methods. Read more about this study
- Who is it for?
- Ages 37 to 39 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Stress
- How many people
- 3 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Feb 2024to 1 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 37 to 39 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: The participants were selected from female pediatric dentists working at the Department of Pediatric Dentistry, Faculty of Dentistry, Erciyes University.
Who may be able to join
- 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
Who cannot join
- pregnant women
- breastfeeding mothers
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Erciyes University Faculty of Dentistry, Department of Pediatric Dentistry
Kayseri, Melikgazi, 38039
About this study
Official title: Evaluation Of Stress Levels Of A Group Of Pediatric Dentist During Laryngeal Mask, Deep Sedation And General Anesthesia Procedures
This study will measure the stress levels of pediatric dentists performing dental treatments under deep sedation and general anesthesia. Stress levels will be compared during sedation and general anesthesia procedures performed using three different methods. Salivary alpha-amylase and salivary cortisol levels will be measured to assess stress.
Read the 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.
- Conditions
- Stress
- Keywords
- paediatric dentist, stress, general anesthesia, laryngeal mask, nasal mask, salivary cortisol, salivary alpha amylase, deep sedation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. | |
| 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. | |
| general anesthesia | Three pediatric dentists each treated 14 patients under general anesthesia. The dentists' stress levels were measured throughout the treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
salivary alpha amylase
Alpha amylase levels were measured in saliva samples taken from pediatric dentists.
Measured: Measurements were taken three times: 10 minutes before each treatment, 25 minutes after treatment begins, and 10 minutes after the treatment.
salivary cortisol
Cortisol levels were measured in saliva samples taken from pediatric dentists.
Measured: Measurements were taken three times: 10 minutes before each treatment, 25 minutes after treatment begins, and 10 minutes after the treatment.
systolic and diastolic blood pressure
Systolic and diastolic blood pressure was measured in pediatric dentists.
Measured: Measurements were taken three times: 10 minutes before each treatment, 25 minutes after treatment begins, and 10 minutes after the treatment.
pulse
The pulse of pediatric dentists was taken.
Measured: Measurements were taken three times: 10 minutes before each treatment, 25 minutes after treatment begins, and 10 minutes after the treatment.
oxygen saturation
Oxygen saturation was measured in pediatric dentists.
Measured: Measurements were taken three times: 10 minutes before each treatment, 25 minutes after treatment begins, and 10 minutes after the treatment.
Visual Analog Scale (VAS) score
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.
Measured: Each physician conducted an evaluation at the end of each treatment session.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2026
- Study start15 Feb 2024
- Primary completion15 Feb 2025
- Study completion1 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for StressStudies of the same condition, open and under way.
- More trials run by TC Erciyes UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve Kepezkaya, TC Erciyes University
- Investigators
- Esra Kızılcı, Study director, Erciyes Üniversitesi Diş Hekimliği Fakültesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07541508
- Sponsor's protocol ID
- EU-DHF-MK-01
- Status last verified
- Apr 2026
- First submitted
- 18 Dec 2025
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lesage FX, Berjot S. Validity of occupational stress assessment using a visual analogue scale. Occup Med (Lond). 2011 Sep;61(6):434-6. doi: 10.1093/occmed/kqr037. Epub 2011 Apr 19.
PubMed 21505089Nater UM, Rohleder N. Salivary alpha-amylase as a non-invasive biomarker for the sympathetic nervous system: current state of research. Psychoneuroendocrinology. 2009 May;34(4):486-96. doi: 10.1016/j.psyneuen.2009.01.014. Epub 2009 Feb 26.
PubMed 19249160Hellhammer 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.
PubMed 19095358Lovallo 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. Circ Cardiovasc Imaging. 2020 Aug;13(8):e011054. doi: 10.1161/CIRCIMAGING.120.011054. Epub 2020 Aug 7.
PubMed 32762255Giacomello G, Scholten A, Parr MK. Current methods for stress marker detection in saliva. J Pharm Biomed Anal. 2020 Nov 30;191:113604. doi: 10.1016/j.jpba.2020.113604. Epub 2020 Sep 6.
PubMed 32957066Chojnowska S, Ptaszynska-Sarosiek I, Kepka A, Knas M, Waszkiewicz N. Salivary Biomarkers of Stress, Anxiety and Depression. J Clin Med. 2021 Feb 1;10(3):517. doi: 10.3390/jcm10030517.
PubMed 33535653Song KW, Kim HK. Job stress and its related factors among Korean dentists: An online survey study. Int Dent J. 2019 Dec;69(6):436-444. doi: 10.1111/idj.12513. Epub 2019 Aug 6.
PubMed 31388997Kizilci E, Kizilay F, Mahyaddinova T, Muhtaroglu S, Kolcakoglu K. Stress levels of a group of dentists while providing dental care under clinical, deep sedation, and general anesthesia. Clin Oral Investig. 2023 Jul;27(7):3601-3609. doi: 10.1007/s00784-023-04973-9. Epub 2023 Mar 30.
PubMed 36995430Anabuki AA, Correa-Faria P, Batista AC, Costa LR. Paediatric dentists' stress during dental care for children under sedation: a cross-sectional study. Eur Arch Paediatr Dent. 2021 Apr;22(2):301-306. doi: 10.1007/s40368-020-00565-3. Epub 2020 Oct 6.
PubMed 33025398Humphris G. A review of burnout in dentists. Dent Update. 1998 Nov;25(9):392-6.
PubMed 10478032Dewa CS, Lin E, Kooehoorn M, Goldner E. Association of chronic work stress, psychiatric disorders, and chronic physical conditions with disability among workers. Psychiatr Serv. 2007 May;58(5):652-8. doi: 10.1176/ps.2007.58.5.652.
PubMed 17463346Davidovich E, Pessov Y, Baniel A, Ram D. Levels of Stress among General Practitioners, Students and Specialists In Pediatric Dentistry during Dental Treatment. J Clin Pediatr Dent. 2015 Fall;39(5):419-22. doi: 10.17796/1053-4628-39.5.419.
PubMed 26551363
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Of Stress Levels Of A Group Of Pediatric Dentist During Laryngeal Mask, Deep Sedation And General Anesthesia Procedures
- ClinicalTrials.gov ID
- NCT07541508
- Acronym / sponsor ID
- EU-DHF-MK-01
- Conditions
- Stress
- Keywords
- paediatric dentist, stress, general anesthesia, laryngeal mask, nasal mask, salivary cortisol, salivary alpha amylase, deep sedation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 15 Feb 2024 (actual)
- Primary completion
- 15 Feb 2025 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 21 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will measure the stress levels of pediatric dentists performing dental treatments under deep sedation and general anesthesia. Stress levels will be compared during sedation and general anesthesia procedures performed using three different methods. Salivary alpha-amylase and salivary cortisol levels will be measured to assess stress.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
| 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. |
| general anesthesia | – | –Three pediatric dentists each treated 14 patients under general anesthesia. The dentists' stress levels were measured throughout the treatment. |
Who may qualify
- Ages
- 37 to 39 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The participants were selected from female pediatric dentists working at the Department of Pediatric Dentistry, Faculty of Dentistry, Erciyes University.
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (2 listed)
- pregnant women
- breastfeeding mothers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Alpha amylase levels were measured in saliva samples taken from pediatric dentists.
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.
Cortisol levels were measured in saliva samples taken from pediatric dentists.
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.
Systolic and diastolic blood pressure was measured in pediatric dentists.
pulse
Time frame: Measurements were taken three times: 10 minutes before each treatment, 25 minutes after treatment begins, and 10 minutes after the treatment.
The pulse of pediatric dentists was taken.
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.
Oxygen saturation was measured in pediatric dentists.
Visual Analog Scale (VAS) score
Time frame: Each physician conducted an evaluation at the end of each treatment session.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Background: PubMed 21505089Lesage FX, Berjot S. Validity of occupational stress assessment using a visual analogue scale. Occup Med (Lond). 2011 Sep;61(6):434-6. doi: 10.1093/occmed/kqr037. Epub 2011 Apr 19.
- Background: PubMed 19249160Nater UM, Rohleder N. Salivary alpha-amylase as a non-invasive biomarker for the sympathetic nervous system: current state of research. Psychoneuroendocrinology. 2009 May;34(4):486-96. doi: 10.1016/j.psyneuen.2009.01.014. Epub 2009 Feb 26.
- Background: PubMed 19095358Hellhammer 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.
- BackgroundLovallo WR, Buchanan TW. Stress hormones in psychophysiological research: emotional, behavioral, and cognitive implications. 2017.
- BackgroundÖzmert S. Derin Sedasyon Altında Dental Tedavi Uygulanan Çocuklarda Anestezik Yaklaşımın Değerlendirilmesi. Turkish Journal of Pediatric Disease. 2019;13(1):30-5.
- Background: PubMed 32762255Meadows JL, Shah S, Burg MM, Pfau S, Soufer R. Cardiovascular Imaging of Biology and Emotion: Considerations Toward a New Paradigm. Circ Cardiovasc Imaging. 2020 Aug;13(8):e011054. doi: 10.1161/CIRCIMAGING.120.011054. Epub 2020 Aug 7.
- Background: PubMed 32957066Giacomello G, Scholten A, Parr MK. Current methods for stress marker detection in saliva. J Pharm Biomed Anal. 2020 Nov 30;191:113604. doi: 10.1016/j.jpba.2020.113604. Epub 2020 Sep 6.
- Background: PubMed 33535653Chojnowska S, Ptaszynska-Sarosiek I, Kepka A, Knas M, Waszkiewicz N. Salivary Biomarkers of Stress, Anxiety and Depression. J Clin Med. 2021 Feb 1;10(3):517. doi: 10.3390/jcm10030517.
- Background: PubMed 31388997Song KW, Kim HK. Job stress and its related factors among Korean dentists: An online survey study. Int Dent J. 2019 Dec;69(6):436-444. doi: 10.1111/idj.12513. Epub 2019 Aug 6.
- Background: PubMed 36995430Kizilci E, Kizilay F, Mahyaddinova T, Muhtaroglu S, Kolcakoglu K. Stress levels of a group of dentists while providing dental care under clinical, deep sedation, and general anesthesia. Clin Oral Investig. 2023 Jul;27(7):3601-3609. doi: 10.1007/s00784-023-04973-9. Epub 2023 Mar 30.
- Background: PubMed 33025398Anabuki AA, Correa-Faria P, Batista AC, Costa LR. Paediatric dentists' stress during dental care for children under sedation: a cross-sectional study. Eur Arch Paediatr Dent. 2021 Apr;22(2):301-306. doi: 10.1007/s40368-020-00565-3. Epub 2020 Oct 6.
- Background: PubMed 10478032Humphris G. A review of burnout in dentists. Dent Update. 1998 Nov;25(9):392-6.
- saliva alpha amylase measurement protocolLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Esra Kızılcı study director
Erciyes Üniversitesi Diş Hekimliği Fakültesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stress, run by TC Erciyes University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07541508, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.