Stress, JobNCT05394480
Stress Level Among Dentists in Performing Treatment
A study testing Blood pressure (Systolic, Diastolic), Pulse value, O2 saturations were measured. in people with Stress, Job, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial summary
Purpose: To evaluate the stress levels of dentists working under clinical, deep sedation, or general anaesthesia. Methods: Blood pressure (Systolic, Diastolic blood pressure), Pulse value, O2 saturations were measured, and saliva samples were taken by the dentists 10 minutes before the dental treatment, at the 25th… Read more about this study
- Who is it for?
- Ages 30 to 33 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Stress, Job
- What is being tested?
- Blood pressure (Systolic, Diastolic), Pulse value, O2 saturations were measured.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jan 2021to 14 Aug 2021
- Phase
- Interventional
- 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 30 to 33 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 4 dentists, who started their specialization training, simultaneously in Erciyes University Faculty of Dentistry, Department of Pediatric Dentistry, with equal clinical experience and training.
- Woman
- Between the ages of 30-33
- Weights 52-55 kg
- No systemic disease
- Dentists who have actively treated patients for at least 2 years in a clinic, with deep sedation and general anaesthesia are included.
Who cannot join
- Children who were previously hospitalized due to health problems or who did not live with their biological family were also excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Stress Level Among Dentists In Performing Treatment In Clinic, Deep Sedation, and General Anesthesia
Purpose: To evaluate the stress levels of dentists working under clinical, deep sedation, or general anaesthesia. Methods: Blood pressure (Systolic, Diastolic blood pressure), Pulse value, O2 saturations were measured, and saliva samples were taken by the dentists 10 minutes before the dental treatment, at the 25th minute of the treatment, and 30 minutes after the treatment under clinic, deep sedation, and general anesthesia. Salivary cortisol was measured by electrochemiluminescence (ECLIA) method using the Cobas Cortisol ll kit. The data are analayse statistically
Read the detailed description
Occupational stress, defined as when the resources of the individual are not sufficient to cope with the needs of a situation, is a leading modern health and safety challenge 2.
Although stress is defined as a feeling of tension and pressure, small amounts of stress can be helpful for the individual to cope with difficult situations. The dentist who wants to provide the best treatment for the patient can feel stress and uneasiness when the current conditions are inappropriate. If this stress of dentist is very the desired amount, it can lead to harmful results for patient health.
Especially in pediatric dentistry, behaviour management problems in children, parents' expectations, and behaviours can be more stressful and exhausting in practice. A dentist' s fear and anxiety in children can create various difficulties for the child, parents, dentists, and their team.
Deep sedation is the method in which consciousness is suppressed in a controlled manner by the drug applied, partial loss of protective reflexes, and the response to verbal stimuli is removed. General anaesthesia, on the other hand, is a condition in which the level of patient unconsciousness can be controlled, the patient's protective reflexes are partially or wholly lost, he cannot protect the airway independently, and cannot respond to verbal commands or physical stimuli. Ensuring and maintaining airway patency is vital in sedation applications. In anaesthesia applications, deep sedation in dental procedures is challenging due to the anatomical proximity of the surgical area to the airway, the risk of microaspiration. Dental treatment with general anaesthesia is seen that it is a stressful situation for the practitioner since some complications such as neurological damage, cardiac and respiratory arrest, and even death may occur.
In healthy individuals, stimulation of the sympathetic nervous system at the beginning of the stress response begins with the secretion of epinephrine and norepinephrine from the adrenal medulla. For this reason, sympathetic activity is measured by various evaluation methods such as heart rate, blood pressure, O2 saturation. Salivary cortisol has been accepted as a reliable biomarker of the Hypothalamus-Pituitary-Adrenal system as a delayed stress response.
In the literature review, very few studies investigated occupational stress related to pediatric dentistry. Furthermore, no study was found in which the stress situation in three treatment protocols was evaluated and compared. It was aimed to evaluate the stress which was experienced by dentists working with children while treating children in all three treatment protocols by using objective tests. The H0 hypothesis of the study is that the stress levels of dentists change according to the different treatment protocols.
METHODS This study was approval required for the study was obtained by the clinical research ethics committee from University (No: 82021/32) and conducted following the principles of the Declaration of Helsinki. Both the parents and their children and dentists who agreed to participate in the study provided informed consent.
According to the power analysis, the estimated number of samples was determined as 9 patients in each groups (α error 0.05 and 1-β=0.80). Therefore, each dentist treated 27 patients in 3 different treatment approaches, and the study resulted in a total of 108 patients.Blood pressure (Systolic, Diastolic blood pressure), Pulse value, O2 saturations were measured, and saliva samples were taken by the dentists 10 minutes before the dental treatment, at the 25th minute of the treatment, and 30 minutes after the treatment for all 3 treatment approaches The Saliva Swab Sample Collection kit was used to collect saliva samples. It was placed under the tongue for 2 minutes and was ensured that the swab absorbed the saliva. Afterwards, the swab was centrifuged and placed in saliva storage tubes with a perforated chamber for separating saliva and remaining dry swab. Samples were centrifuged at 3000 rpm for 15 minutes, saliva was cleared of debris and poured to the bottom of the storage tube. Then, saliva in the plastic saliva storage tube was stored at -80 ºC in an upright position until measurements were made 30. After the saliva samples were thawed at room temperature on the day of the measurements, they were taken to the University Medical Faculty Central Biochemistry Laboratory for analysis.
Salivary Cortisol Measurement Protocol:
Salivary cortisol was measured by electrochemiluminescence (ECLIA) method using the Cobas Cortisol ll kit (Roche Diagnostics GmbH; Mannheim, Germany).
10 µL of sample is incubated with cortisol-specific biotinylated antibody and cortisol derivative labelled with ruthenium complex. Depending on the analyte concentration in the sample and the formation of the respective immune complex, the labelled antibody binding site is filled partly with the sample analyte and partly with the ruthenium hapten.
After streptavidin-coated microparticles have been added, biotin and streptavidin interact. The complex becomes bound to the solid phase.
The reaction mixture is aspirated into the measuring cell on the surface of the electrode. The measuring cell is that the microparticles, magnetically, are captured. Unbound substances are then removed with ProCell/ProCell M. Applying voltage to the electrode induces chemiluminescence emission, which is measured with a photomultiplier.
An instrument-specific calibration curve determines results with 2-point calibration and a master curve acquired via the reagent barcode 30.
Statistical analysis In the study, the analyzes were made with the SPSS 25.0 program. On the analysis of data, descriptive statistics are presented with mean and standard deviation values. In the study, the Kruskal Wallis test was performed to examine the differences in measurements according to dentists and treatment approaches. Mann Whitney U test was used to reveal the evaluation that caused the difference. The Friedman test was used to examine the differences between the measurements in the treatment approaches before, during, and after the procedure.
Results When the findings are evaluated according to the measurement times: systolic and diastolic blood pressure measurements for all dentists before the procedure are similar in clinical, general anaesthesia, and sedation (p>0.05). During the procedure, both systolic and diastolic blood pressure measurements were found to be higher under the deep sedation (p<0.05). It was determined that systolic blood pressure measurements did not differ according to under clinical, general anaesthesia, and deep sedation after the procedure (p>0.05), but diastolic blood pressure measurements differed according to treatment approaches. The measurements under the deep sedation were higher than the clinical and general anaesthesia (p<0.05). Pulse and oxygen saturation measurements before, during, and after the treatment did not differ under clinical, general anaesthesia, and deep sedation. It was observed that cortisol measurements before and during the treatment were not at different levels compared to clinical, general anaesthesia, and deep sedation (p>0.05). After the procedure, cortisol measurements under the deep sedation were higher than clinical and general anaesthesia (p<0.05).
It was observed that the heart rate measurements were at similar levels before, during, and after the procedure under clinical and general anaesthesia. Under the deep sedation, it was determined that the heart rate measurements during the procedure were at higher levels than before and after the procedure (p<0.05).
When authors evaluated the oxygen saturation measurements, the oxygen saturation during the procedure was lower than before and after the procedure.
Cortisol measurements were found to be at different levels according to the processing times in Table 2.
- Conditions
- Stress, Job
- Being tested
- Blood pressure (Systolic, Diastolic), Pulse value, O2 saturations were measured.
- Keywords
- DEEP SEDATION, GENERAL ANESTHESIA, pediatric dentistry, STRESS LEVELS
- Medical subject headings
- Occupational Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood pressure (Systolic, Diastolic), Pulse value, O2 saturations were measured.Diagnostic test
Also called Salivary cortisol
Salivary cortisol was measured by electrochemiluminescence (ECLIA) method using the Cobas Cortisol ll kit.
| Study group | Role | What they receive |
|---|---|---|
| clinical treatment | Experimental | 4 dentist treated 36 patient in clinical group
- For treatment in a clinic, children with positive or definitely positive (Frankl 3 and 4) behaviour according to the Frankl Scale (Behavior Evaluation Scale) 28, with the data observed in the first session, were included in the clinical treatment group. According to the clinical examination of these patients, 36 healthy children aged 5-6 years who did not require pulpal treatment and whose caries level was 1-4 according to the ICDAS (International Caries Detection And Assessment System) 29 scoring were selected. The limits of the treatment were determined as compomer filling applied to 2 primary molars after local anaesthesia, and the duration of the treatment was limited to 30 to 60 minutes. Receives: Diagnostic Test: Blood pressure (Systolic, Diastolic), Pulse value, O2 saturations were measured. |
| deep sedation | Experimental | 4 dentist treated 36 patient in clinical group
- Children aged 48-72 months, children with negative or absolutely negative behaviour (Frankl 1 and 2) according to the Frankl Scale, were reserved for treatment under deep sedation. In order to provide standardization among patients suitable for sedation, 36 children (n=9) whose dmft (decayed, missing, filled teeth index) were less than their age, and the duration of the procedure would be limited to between 30 and 40 minutes, were included in the study. Receives: Diagnostic Test: Blood pressure (Systolic, Diastolic), Pulse value, O2 saturations were measured. |
| general anaesthesia | Experimental | 4 dentist treated 36 patient in clinical group
- Children aged 48-72 months, children with negative or definitely negative behaviour according to the Frankl Scale (Frankl 1 and 2), were reserved for treatment under general anaesthesia. In order to provide standardization among patients suitable for general anaesthesia, 36 healthy children (n=9) whose dmft was equal to, or higher than their age were allocated. In addition, patients whose treatment time would be limited to 30 to 60 minutes were included. Receives: Diagnostic Test: Blood pressure (Systolic, Diastolic), Pulse value, O2 saturations were measured. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Salivary cortisol
Salivary cortisol was measured by electrochemiluminescence (ECLIA) method using the Cobas Cortisol ll kit.
Measured: saliva samples were taken by the dentists 10 minutes before the dental treatment
Salivary cortisol
Salivary cortisol was measured by electrochemiluminescence (ECLIA) method using the Cobas Cortisol ll kit.
Measured: saliva samples were taken by the dentists at the 25th minute of the treatment
Salivary cortisol
Salivary cortisol was measured by electrochemiluminescence (ECLIA) method using the Cobas Cortisol ll kit.
Measured: saliva samples were taken by the dentists at the 30 minutes after the treatment
Secondary outcomes (6)
Systolic, Blood pressure
Systolic Blood pressure were measured with Automatic Wrist Blood Pressure Monitor, as (mmHg)
Measured: Systolic Blood pressure were measured by the dentists 10 minutes before the dental treatment
Diastolic Blood pressure
Diastolic Blood pressure were measured with Automatic Wrist Blood Pressure Monitor, as (mmHg)
Measured: Diastolic Blood pressure were measured by the dentists 10 minutes before the dental treatment
Systolic Blood pressure
Systolic Blood pressure were measured with Automatic Wrist Blood Pressure Monitor, as (mmHg)
Measured: Systolic Blood pressure were measured by the dentists at the 25th minute of the treatment
Diastolic Blood pressure
Diastolic Blood pressure were measured with Automatic Wrist Blood Pressure Monitor, as (mmHg)
Measured: Diastolic Blood pressure were measured by the dentists at the 25th minute of the treatment
Systolic Blood pressure
Systolic Blood pressure were measured with Automatic Wrist Blood Pressure Monitor, as (mmHg)
Measured: Systolic Blood pressure were measured by the dentists 30 minutes after the treatment
Diastolic Blood pressure
Diastolic Blood pressure were measured with Automatic Wrist Blood Pressure Monitor, as (mmHg)
Measured: Diastolic Blood pressure were measured by the dentists 30 minutes after the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2022
- Study start20 Jan 2021
- Primary completion24 Apr 2021
- Study completion14 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stress, JobStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Model description
- In the present study, it was aimed to evaluate the stress which was experienced by dentists working with children while treating children in all three treatment protocols by using objective (salivary cortisol, pulse, blood pressure, O2 saturation) and subjective (Dentists' Stress Questionnaire) findings 27. The H0 hypothesis of the study is that the stress levels of dentists change according to the different treatment protocols. each dentist treated 27 patients in 3 different treatment approaches, and the study resulted in a total of 108 patients.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, esra kizilci, TC Erciyes University
- Investigators
- ESRA KIZILCI, 1, Study chair, erciyes university pediatric dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05394480
- Sponsor's protocol ID
- 82021
- Status last verified
- May 2022
- First submitted
- 2 Jan 2022
- Last updated
- 27 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The raw data are available in the authors
Publications
Basu S, Qayyum H, Mason S. Occupational stress in the ED: a systematic literature review. Emerg Med J. 2017 Jul;34(7):441-447. doi: 10.1136/emermed-2016-205827. Epub 2016 Oct 11.
PubMed 27729392
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stress Level Among Dentists In Performing Treatment In Clinic, Deep Sedation, and General Anesthesia
- ClinicalTrials.gov ID
- NCT05394480
- Acronym / sponsor ID
- 82021
- Conditions
- Stress, Job
- Keywords
- DEEP SEDATION, GENERAL ANESTHESIA, pediatric dentistry, STRESS LEVELS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 20 Jan 2021 (actual)
- Primary completion
- 24 Apr 2021 (actual)
- Study completion
- 14 Aug 2021 (actual)
- First posted
- 27 May 2022 (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.
Purpose: To evaluate the stress levels of dentists working under clinical, deep sedation, or general anaesthesia. Methods: Blood pressure (Systolic, Diastolic blood pressure), Pulse value, O2 saturations were measured, and saliva samples were taken by the dentists 10 minutes before the dental treatment, at the 25th minute of the treatment, and 30 minutes after the treatment under clinic, deep sedation, and general anesthesia. Salivary cortisol was measured by electrochemiluminescence (ECLIA) method using the Cobas Cortisol ll kit. The data are analayse statistically
Detailed description
Occupational stress, defined as when the resources of the individual are not sufficient to cope with the needs of a situation, is a leading modern health and safety challenge 2.
Although stress is defined as a feeling of tension and pressure, small amounts of stress can be helpful for the individual to cope with difficult situations. The dentist who wants to provide the best treatment for the patient can feel stress and uneasiness when the current conditions are inappropriate. If this stress of dentist is very the desired amount, it can lead to harmful results for patient health.
Especially in pediatric dentistry, behaviour management problems in children, parents' expectations, and behaviours can be more stressful and exhausting in practice. A dentist' s fear and anxiety in children can create various difficulties for the child, parents, dentists, and their team.
Deep sedation is the method in which consciousness is suppressed in a controlled manner by the drug applied, partial loss of protective reflexes, and the response to verbal stimuli is removed. General anaesthesia, on the other hand, is a condition in which the level of patient unconsciousness can be controlled, the patient's protective reflexes are partially or wholly lost, he cannot protect the airway independently, and cannot respond to verbal commands or physical stimuli. Ensuring and maintaining airway patency is vital in sedation applications. In anaesthesia applications, deep sedation in dental procedures is challenging due to the anatomical proximity of the surgical area to the airway, the risk of microaspiration. Dental treatment with general anaesthesia is seen that it is a stressful situation for the practitioner since some complications such as neurological damage, cardiac and respiratory arrest, and even death may occur.
In healthy individuals, stimulation of the sympathetic nervous system at the beginning of the stress response begins with the secretion of epinephrine and norepinephrine from the adrenal medulla. For this reason, sympathetic activity is measured by various evaluation methods such as heart rate, blood pressure, O2 saturation. Salivary cortisol has been accepted as a reliable biomarker of the Hypothalamus-Pituitary-Adrenal system as a delayed stress response.
In the literature review, very few studies investigated occupational stress related to pediatric dentistry. Furthermore, no study was found in which the stress situation in three treatment protocols was evaluated and compared. It was aimed to evaluate the stress which was experienced by dentists working with children while treating children in all three treatment protocols by using objective tests. The H0 hypothesis of the study is that the stress levels of dentists change according to the different treatment protocols.
METHODS This study was approval required for the study was obtained by the clinical research ethics committee from University (No: 82021/32) and conducted following the principles of the Declaration of Helsinki. Both the parents and their children and dentists who agreed to participate in the study provided informed consent.
According to the power analysis, the estimated number of samples was determined as 9 patients in each groups (α error 0.05 and 1-β=0.80). Therefore, each dentist treated 27 patients in 3 different treatment approaches, and the study resulted in a total of 108 patients.Blood pressure (Systolic, Diastolic blood pressure), Pulse value, O2 saturations were measured, and saliva samples were taken by the dentists 10 minutes before the dental treatment, at the 25th minute of the treatment, and 30 minutes after the treatment for all 3 treatment approaches The Saliva Swab Sample Collection kit was used to collect saliva samples. It was placed under the tongue for 2 minutes and was ensured that the swab absorbed the saliva. Afterwards, the swab was centrifuged and placed in saliva storage tubes with a perforated chamber for separating saliva and remaining dry swab. Samples were centrifuged at 3000 rpm for 15 minutes, saliva was cleared of debris and poured to the bottom of the storage tube. Then, saliva in the plastic saliva storage tube was stored at -80 ºC in an upright position until measurements were made 30. After the saliva samples were thawed at room temperature on the day of the measurements, they were taken to the University Medical Faculty Central Biochemistry Laboratory for analysis.
Salivary Cortisol Measurement Protocol:
Salivary cortisol was measured by electrochemiluminescence (ECLIA) method using the Cobas Cortisol ll kit (Roche Diagnostics GmbH; Mannheim, Germany).
10 µL of sample is incubated with cortisol-specific biotinylated antibody and cortisol derivative labelled with ruthenium complex. Depending on the analyte concentration in the sample and the formation of the respective immune complex, the labelled antibody binding site is filled partly with the sample analyte and partly with the ruthenium hapten.
After streptavidin-coated microparticles have been added, biotin and streptavidin interact. The complex becomes bound to the solid phase.
The reaction mixture is aspirated into the measuring cell on the surface of the electrode. The measuring cell is that the microparticles, magnetically, are captured. Unbound substances are then removed with ProCell/ProCell M. Applying voltage to the electrode induces chemiluminescence emission, which is measured with a photomultiplier.
An instrument-specific calibration curve determines results with 2-point calibration and a master curve acquired via the reagent barcode 30.
Statistical analysis In the study, the analyzes were made with the SPSS 25.0 program. On the analysis of data, descriptive statistics are presented with mean and standard deviation values. In the study, the Kruskal Wallis test was performed to examine the differences in measurements according to dentists and treatment approaches. Mann Whitney U test was used to reveal the evaluation that caused the difference. The Friedman test was used to examine the differences between the measurements in the treatment approaches before, during, and after the procedure.
Results When the findings are evaluated according to the measurement times: systolic and diastolic blood pressure measurements for all dentists before the procedure are similar in clinical, general anaesthesia, and sedation (p>0.05). During the procedure, both systolic and diastolic blood pressure measurements were found to be higher under the deep sedation (p<0.05). It was determined that systolic blood pressure measurements did not differ according to under clinical, general anaesthesia, and deep sedation after the procedure (p>0.05), but diastolic blood pressure measurements differed according to treatment approaches. The measurements under the deep sedation were higher than the clinical and general anaesthesia (p<0.05). Pulse and oxygen saturation measurements before, during, and after the treatment did not differ under clinical, general anaesthesia, and deep sedation. It was observed that cortisol measurements before and during the treatment were not at different levels compared to clinical, general anaesthesia, and deep sedation (p>0.05). After the procedure, cortisol measurements under the deep sedation were higher than clinical and general anaesthesia (p<0.05).
It was observed that the heart rate measurements were at similar levels before, during, and after the procedure under clinical and general anaesthesia. Under the deep sedation, it was determined that the heart rate measurements during the procedure were at higher levels than before and after the procedure (p<0.05).
When authors evaluated the oxygen saturation measurements, the oxygen saturation during the procedure was lower than before and after the procedure.
Cortisol measurements were found to be at different levels according to the processing times in Table 2.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
- Model description
- In the present study, it was aimed to evaluate the stress which was experienced by dentists working with children while treating children in all three treatment protocols by using objective (salivary cortisol, pulse, blood pressure, O2 saturation) and subjective (Dentists' Stress Questionnaire) findings 27. The H0 hypothesis of the study is that the stress levels of dentists change according to the different treatment protocols. each dentist treated 27 patients in 3 different treatment approaches, and the study resulted in a total of 108 patients.
| Arm | Type | Receives |
|---|---|---|
| clinical treatment | Experimental | Diagnostic Test: Blood pressure (Systolic, Diastolic), Pulse value, O2 saturations were measured.4 dentist treated 36 patient in clinical group - For treatment in a clinic, children with positive or definitely positive (Frankl 3 and 4) behaviour according to the Frankl Scale (Behavior Evaluation Scale) 28, with the data observed in the first session, were included in the clinical treatment group. According to the clinical examination of these patients, 36 healthy children aged 5-6 years who did not require pulpal treatment and whose caries level was 1-4 according to the ICDAS (International Caries Detection And Assessment System) 29 scoring were selected. The limits of the treatment were determined as compomer filling applied to 2 primary molars after local anaesthesia, and the duration of the treatment was limited to 30 to 60 minutes. |
| deep sedation | Experimental | Diagnostic Test: Blood pressure (Systolic, Diastolic), Pulse value, O2 saturations were measured.4 dentist treated 36 patient in clinical group - Children aged 48-72 months, children with negative or absolutely negative behaviour (Frankl 1 and 2) according to the Frankl Scale, were reserved for treatment under deep sedation. In order to provide standardization among patients suitable for sedation, 36 children (n=9) whose dmft (decayed, missing, filled teeth index) were less than their age, and the duration of the procedure would be limited to between 30 and 40 minutes, were included in the study. |
| general anaesthesia | Experimental | Diagnostic Test: Blood pressure (Systolic, Diastolic), Pulse value, O2 saturations were measured.4 dentist treated 36 patient in clinical group - Children aged 48-72 months, children with negative or definitely negative behaviour according to the Frankl Scale (Frankl 1 and 2), were reserved for treatment under general anaesthesia. In order to provide standardization among patients suitable for general anaesthesia, 36 healthy children (n=9) whose dmft was equal to, or higher than their age were allocated. In addition, patients whose treatment time would be limited to 30 to 60 minutes were included. |
Who may qualify
- Ages
- 30 to 33 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 4 dentists, who started their specialization training, simultaneously in Erciyes University Faculty of Dentistry, Department of Pediatric Dentistry, with equal clinical experience and training.
- Woman
- Between the ages of 30-33
- Weights 52-55 kg
- No systemic disease
Key exclusion criteria (1 listed)
- Children who were previously hospitalized due to health problems or who did not live with their biological family were also excluded from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood pressure (Systolic, Diastolic), Pulse value, O2 saturations were measured.Also: Salivary cortisolSalivary cortisol was measured by electrochemiluminescence (ECLIA) method using the Cobas Cortisol ll kit. | Diagnostic test | clinical treatment, deep sedation, general anaesthesia |
Primary outcome
Salivary cortisol
Time frame: saliva samples were taken by the dentists 10 minutes before the dental treatment
Salivary cortisol was measured by electrochemiluminescence (ECLIA) method using the Cobas Cortisol ll kit.
Salivary cortisol
Time frame: saliva samples were taken by the dentists at the 25th minute of the treatment
Salivary cortisol was measured by electrochemiluminescence (ECLIA) method using the Cobas Cortisol ll kit.
Salivary cortisol
Time frame: saliva samples were taken by the dentists at the 30 minutes after the treatment
Salivary cortisol was measured by electrochemiluminescence (ECLIA) method using the Cobas Cortisol ll kit.
6 secondary outcomes
Systolic, Blood pressure
Time frame: Systolic Blood pressure were measured by the dentists 10 minutes before the dental treatment
Diastolic Blood pressure
Time frame: Diastolic Blood pressure were measured by the dentists 10 minutes before the dental treatment
Systolic Blood pressure
Time frame: Systolic Blood pressure were measured by the dentists at the 25th minute of the treatment
Diastolic Blood pressure
Time frame: Diastolic Blood pressure were measured by the dentists at the 25th minute of the treatment
Systolic Blood pressure
Time frame: Systolic Blood pressure were measured by the dentists 30 minutes after the treatment
Diastolic Blood pressure
Time frame: Diastolic Blood pressure were measured by the dentists 30 minutes after the treatment
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 27 May 2022.
- Background: PubMed 27729392Basu S, Qayyum H, Mason S. Occupational stress in the ED: a systematic literature review. Emerg Med J. 2017 Jul;34(7):441-447. doi: 10.1136/emermed-2016-205827. Epub 2016 Oct 11.
- Individual participant dataSharing planned: No. The raw data are available in the authors
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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 KIZILCI, 1 study chair
erciyes university pediatric dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood pressure (Systolic, Diastolic), Pulse value, O2 saturations were measured. in people with Stress, Job, 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 1 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 27 May 2022. 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 cortisol (time frame: saliva samples were taken by the dentists 10 minutes before the dental treatment). The study lists 3 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 NCT05394480, which also lists 1 linked publication.
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 27 May 2022.