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Behavioral Support Techniques on Anxiety and Physical Reaction From Dental Treatment

Not Applicable
Conditions
Dental Anxiety
Dental Trauma
Dental Diseases
Interventions
Device: without deep touch pressure application
Device: with deep touch pressure application
Registration Number
NCT03819166
Lead Sponsor
National Taiwan University Hospital
Brief Summary

Application of deep touch pressure (DTP) has been suggested to provide positive effects on anxiety modulation. However, empirical and theoretical evidence linked to the clinical effects of DTP is relatively rare in the behavioral and physiological aspects. The aim of this intervention trial study designs to investigate the effect of DTP in dental treatment by quantitative analysis of behavioral assessments and physiological measurements, including the electrodermal activity and heart rate variability, were conducted to understand the modulation of the autonomic nervous system (ANS), the orchestration of sympathetic (SNS) and parasympathetic (PsNS) nervous systems.

Detailed Description

The subjects were recruited through word-of-mouth and by posted sign-up from the Department of Dentistry, National Taiwan University Hospital (NTUH), Taiwan. Informed consent was obtained prior to participation. The study protocol was approved by the Human Research Ethics Committee of NTUH. Before the testing, the experimental protocol was explained to the subjects. The subjects with normal overnight sleep quality were recruited to prevent the influences in both physiological and physical fatigue. All potential subjects receive independent examinations by an occupational therapist and a dentist to determine the eligibility for inclusion as well as were blind to the study hypotheses. Both electrodermal activity (EDA) and heart rate variability (HRV) were recorded continually through the entire testing procedures. Since the EDA and HRV are sensitive indicators for autonomic nervous system modulation, a standardization procedure that ensures the integrity of data is accessed. The power of the testing is preset at 0.80, and the significant level is 0.05. The quasi-experimental design of clinical trial for repeated measures will be used.

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
200
Inclusion Criteria
  • Patients who requiring tooth extraction were potentially selected to recruit.
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Exclusion Criteria
  • with a history of systemic diseases that would contraindicate surgical treatment
  • pregnant and lactating
  • smoking of more than 10 cigarettes per day
  • poor overnight sleep quality
  • refusal to sign the inform consent agreement
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
control groupwithout deep touch pressure applicationThe participants recruited in the group will not receive the input of deep touch pressure during their procedures of dental treatment.
experimental groupwith deep touch pressure applicationThe participants recruited in the group will receive the input of deep touch pressure during their procedures of dental treatment.
Primary Outcome Measures
NameTimeMethod
Heart Rate Variability (HRV)The post-treatment phase is defined as the five minutes after the dental treatment. The HRV data recorded in this phase will be considered as the post-treatment data which used to compare to the baseline and treatment data.

A non-invasive technique to investigate the effect of mental stress of the autonomic nervous system control on heart rate.

Electrodermal Activity (EDA)The post-treatment phase is defined as the five minutes after the dental treatment. The EDA data recorded in this phase will be considered as the post-treatment data which used to compare to the baseline and treatment data.

A non-invasive technique to investigate the effect of mental stress of the sympathetic nervous system control on sweat gland of skin.

Secondary Outcome Measures
NameTimeMethod
Dental Anxiety Scale (DAS)The averaged time of dental treatment is about 40-90 minutes.This questionnaire will be applied immediately after the dental treatment completion.

This questionnaire can range from 4 (not anxious at all) to 20 (extremely anxious).

Numeric State Anxiety Scale (NSAS)The averaged time of dental treatment is about 40-90 minutes.This scale will be scored immediately after the dental treatment completion.

This ordinal scale, range from 0-10, which is represented as a abscissa line to reflect the level of anxiety; 0 and 1 is not at all, 2 to 4 is little, 5 to 7 is medium, 8 and 9 is a lot, and 10 is worst imaginable.

Trial Locations

Locations (1)

National Taiwan University Hospital

🇨🇳

Taipei, Taiwan

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