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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Taiwan University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 11, 2011

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 18, 2013

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 14, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 25, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 28, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 15, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 13, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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