Behavioral Support Techniques on Anxiety and Physical Reaction From Dental Treatment

Dental Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03819166
• Other study ID #: 201012061RC
• Status: Recruiting
• Phase: N/A
• Start date: March 11, 2011
• Est. completion date: January 30, 2022

Study information

• Verified date: January 2021
• Source: National Taiwan University Hospital
• Contact: Hsiang Yang, DDS
• Phone: +886-2-2312345
• Email: dtdent90[@]yahoo.com.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: January 30, 2022
• Est. primary completion date: July 18, 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Dental Anxiety
• Dental Diseases
• Dental Trauma
• Stomatognathic Diseases

Intervention

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.
• without deep touch pressure application
The deep touch pressure will not be applied.

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart Rate Variability (HRV)	A non-invasive technique to investigate the effect of mental stress of the autonomic nervous system control on heart rate.	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.
Primary	Electrodermal Activity (EDA)	A non-invasive technique to investigate the effect of mental stress of the sympathetic nervous system control on sweat gland of skin.	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
Primary	Heart Rate Variability (HRV)	A non-invasive technique to investigate the effect of mental stress of the autonomic nervous system control on heart rate.	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.
Primary	Electrodermal Activity (EDA)	A non-invasive technique to investigate the effect of mental stress of the sympathetic nervous system control on sweat gland of skin.	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.
Primary	Heart Rate Variability (HRV)	A non-invasive technique to investigate the effect of mental stress of the autonomic nervous system control on heart rate.	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.
Primary	Electrodermal Activity (EDA)	A non-invasive technique to investigate the effect of mental stress of the sympathetic nervous system control on sweat gland of skin.	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	Dental Anxiety Scale (DAS)	This questionnaire can range from 4 (not anxious at all) to 20 (extremely anxious).	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.
Secondary	Dental Anxiety Scale (DAS)	This questionnaire can range from 4 (not anxious at all) to 20 (extremely anxious).	The averaged time of dental treatment is about 40-90 minutes.This questionnaire will be applied immediately after the dental treatment completion.
Secondary	Numeric State Anxiety Scale (NSAS)	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.	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.
Secondary	Numeric State Anxiety Scale (NSAS)	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.	The averaged time of dental treatment is about 40-90 minutes.This scale will be scored immediately after the dental treatment completion.