Behavioral Support Techniques on Anxiety and Physical Reaction From Dental Treatment

National Taiwan University

Status: Unknown

Conditions: Dental Trauma; Dental Anxiety; Dental Diseases

Treatments: Device: with deep touch pressure application; Device: without deep touch pressure application

Study type: Interventional

Funder types: Other

Identifiers

NCT03819166

201012061RC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 10 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups

experimental group

Experimental group

Description:

The participants recruited in the group will receive the input of deep touch pressure during their procedures of dental treatment.

Treatment:

Device: with deep touch pressure application

control group

Sham Comparator group

Description:

The participants recruited in the group will not receive the input of deep touch pressure during their procedures of dental treatment.

Treatment:

Device: without deep touch pressure application