NCT03819166

Behavioral Support Techniques on Anxiety and Physical Reaction From Dental Treatment

The Effect of Behavioral Support Techniques on Anxiety and Physical Reaction From Dental Treatment

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: National Taiwan University Hospital · Academic / Other
• Sex: All
• Age: 10 Years – 75 Years
• Healthy volunteers: Accepted

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.

Conditions

• Dental Anxiety
• Dental Diseases
• Dental Trauma

Interventions

Type	Name	Description
DEVICE	with deep touch pressure application	The deep touch pressure is applied by the weight loading devices, including but not limited to, weight blanket and weight vest.
DEVICE	without deep touch pressure application	The deep touch pressure will not be applied.

Timeline

• Start date: 2011-03-11
• Primary completion: 2013-07-18
• Completion: 2022-01-30
• First posted: 2019-01-28
• Last updated: 2021-01-15

Locations

1 site across 1 country: Taiwan