Behavioral Support Techniques on Anxiety and Physical Reaction From Dental Treatment

January 13, 2021 updated by: National Taiwan University Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 100
        • Recruiting
        • National Taiwan University Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Hsiang Yang, DDS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 75 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: experimental group
The participants recruited in the group will receive the input of deep touch pressure during their procedures of dental treatment.
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.
SHAM_COMPARATOR: control group
The participants recruited in the group will not receive the input of deep touch pressure during their procedures of dental treatment.
Device: without deep touch pressure application
The deep touch pressure will not be applied.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart Rate Variability (HRV)
Time Frame: 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.
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.
Electrodermal Activity (EDA)
Time Frame: 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.
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
Heart Rate Variability (HRV)
Time Frame: 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.
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.
Electrodermal Activity (EDA)
Time Frame: 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.
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.
Heart Rate Variability (HRV)
Time Frame: 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.
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.
Electrodermal Activity (EDA)
Time Frame: 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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dental Anxiety Scale (DAS)
Time Frame: 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).
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.
Dental Anxiety Scale (DAS)
Time Frame: The averaged time of dental treatment is about 40-90 minutes.This questionnaire will be applied immediately after the dental treatment completion.
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.
Numeric State Anxiety Scale (NSAS)
Time Frame: 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.
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.
Numeric State Anxiety Scale (NSAS)
Time Frame: The averaged time of dental treatment is about 40-90 minutes.This scale will be scored immediately after the dental treatment completion.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Investigators

  • Principal Investigator: Hsiagn Yang, DDS, Department of Dentistry, National Taiwan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 11, 2011

Primary Completion (ACTUAL)

July 18, 2013

Study Completion (ANTICIPATED)

January 30, 2022

Study Registration Dates

First Submitted

January 14, 2019

First Submitted That Met QC Criteria

January 25, 2019

First Posted (ACTUAL)

January 28, 2019

Study Record Updates

Last Update Posted (ACTUAL)

January 15, 2021

Last Update Submitted That Met QC Criteria

January 13, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201012061RC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is not a plan to make IPD available.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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