Clinical trial NCT03819166: Behavioral Support Techniques on Anxiety and Physical Reaction From Dental Treatment
Official title: The Effect of Behavioral Support Techniques on Anxiety and Physical Reaction From Dental Treatment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dental Anxiety
Dental Diseases
Dental Trauma
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2019-01-28
Enrollment: 200
Sex: ALL
Minimum age (years): 10
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Inclusion Criteria:

* Patients who requiring tooth extraction were potentially selected to recruit.

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

Primary outcomes:
measure: Heart Rate Variability (HRV)
timeFrame: The baseline phase is defined as the five minutes before the dental treatment. The HRV data recorded in this phase will be considered as the baseline data of this study.
measure: Electrodermal Activity (EDA)
timeFrame: The baseline phase is defined as the five minutes before the dental treatment. The EAD data recorded in this phase will be considered as the baseline data of this study
measure: Heart Rate Variability (HRV)
timeFrame: The treatment phase is the period of the entire procedures of dental treatment, approximate 40-90 minutes. The HRV data will be recorded to investigate the changes both during the dental treatment and in the application of deep touch pressure.
measure: Electrodermal Activity (EDA)
timeFrame: The treatment phase is the period of the entire procedures of dental treatment, approximate 40-90 minutes. The EDA data will be recorded to investigate the changes both during the dental treatment and in the application of deep touch pressure.
measure: Heart Rate Variability (HRV)
timeFrame: 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.
measure: Electrodermal Activity (EDA)
timeFrame: 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.
Secondary outcomes:
measure: Dental Anxiety Scale (DAS)
timeFrame: This questionnaire will be applied in the baseline phase (immediately after HRV measurement and about 5 minutes before dental procedures) to know anxiety condition of participants before the dental treatment.
measure: Dental Anxiety Scale (DAS)
timeFrame: The averaged time of dental treatment is about 40-90 minutes.This questionnaire will be applied immediately after the dental treatment completion.
measure: Numeric State Anxiety Scale (NSAS)
timeFrame: This scale will be scored in the baseline phase (immediately after HRV measurement and about 5 minutes before dental procedures) to identify the anxiety state of participants before the dental treatment.
measure: Numeric State Anxiety Scale (NSAS)
timeFrame: The averaged time of dental treatment is about 40-90 minutes.This scale will be scored immediately after the dental treatment completion.
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: Department of Dentistry, National Taiwan University Hospital
name: Hsiagn Yang, DDS
role: PRINCIPAL_INVESTIGATOR
References: