Behavioral Support Techniques on Anxiety and Physical Reaction From Dental Treatment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-11

Study Completion Date

2022-01-30

Brief Summary

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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.

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Detailed Description

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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

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Dental Anxiety Dental Diseases Dental Trauma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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experimental group

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

Group Type EXPERIMENTAL

with deep touch pressure application

Intervention Type DEVICE

The deep touch pressure is applied by the weight loading devices, including but not limited to, weight blanket and weight vest.

control group

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

Group Type SHAM_COMPARATOR

without deep touch pressure application

Intervention Type DEVICE

The deep touch pressure will not be applied.

Interventions

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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.

Intervention Type DEVICE

without deep touch pressure application

The deep touch pressure will not be applied.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

10 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes