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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).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Turkey (Türkiye)1 site
  • Esra Kizilci

    Kayseri, 38000

Other trials in Turkey (Türkiye)

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 groups in NCT05394480
Study groupRoleWhat they receive
clinical treatmentExperimental4 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 sedationExperimental4 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 anaesthesiaExperimental4 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.

  1. 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

  2. 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

  3. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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.

  1. First posted27 May 2022
  2. Study start20 Jan 2021
  3. Primary completion24 Apr 2021
  4. Study completion14 Aug 2021

Resources

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)
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

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.

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