Dental Anxiety, Dental Diseases, Dental Trauma
Conditions
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.
Interventions
DEVICEwith 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.
DEVICEwithout deep touch pressure application
The deep touch pressure will not be applied.
Sponsors
National Taiwan University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
10 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Heart Rate Variability (HRV) | 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. | A non-invasive technique to investigate the effect of mental stress of the autonomic nervous system control on heart rate. |
| Electrodermal Activity (EDA) | 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 | A non-invasive technique to investigate the effect of mental stress of the sympathetic nervous system control on sweat gland of skin. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dental Anxiety Scale (DAS) | 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. | This questionnaire can range from 4 (not anxious at all) to 20 (extremely anxious). |
| Numeric State Anxiety Scale (NSAS) | 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. | 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. |
Countries
Taiwan
Contacts
Primary ContactHsiang Yang, DDS
Backup ContactHsin-Ming Chen, DDS, PhD
Outcome results
None listed