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Behavioral Support Techniques on Anxiety and Physical Reaction From Dental Treatment

Primary Purpose

Dental Anxiety, Dental Diseases, Dental Trauma

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
with deep touch pressure application
without deep touch pressure application
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Dental Anxiety

Eligibility Criteria

10 Years - 75 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • National Taiwan University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

experimental group

control group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Heart Rate Variability (HRV)
A non-invasive technique to investigate the effect of mental stress of the autonomic nervous system control on heart rate.
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.
Heart Rate Variability (HRV)
A non-invasive technique to investigate the effect of mental stress of the autonomic nervous system control on heart rate.
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.
Heart Rate Variability (HRV)
A non-invasive technique to investigate the effect of mental stress of the autonomic nervous system control on heart rate.
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.

Secondary Outcome Measures

Dental Anxiety Scale (DAS)
This questionnaire can range from 4 (not anxious at all) to 20 (extremely anxious).
Dental Anxiety Scale (DAS)
This questionnaire can range from 4 (not anxious at all) to 20 (extremely anxious).
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.
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.

Full Information

First Posted
January 14, 2019
Last Updated
January 13, 2021
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03819166
Brief Title
Behavioral Support Techniques on Anxiety and Physical Reaction From Dental Treatment
Official Title
The Effect of Behavioral Support Techniques on Anxiety and Physical Reaction From Dental Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 11, 2011 (Actual)
Primary Completion Date
July 18, 2013 (Actual)
Study Completion Date
January 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Anxiety, Dental Diseases, Dental Trauma

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
experimental group
Arm Type
Experimental
Arm Description
The participants recruited in the group will receive the input of deep touch pressure during their procedures of dental treatment.
Arm Title
control group
Arm Type
Sham Comparator
Arm Description
The participants recruited in the group will not receive the input of deep touch pressure during their procedures of dental treatment.
Intervention Type
Device
Intervention Name(s)
with deep touch pressure application
Intervention Description
The deep touch pressure is applied by the weight loading devices, including but not limited to, weight blanket and weight vest.
Intervention Type
Device
Intervention Name(s)
without deep touch pressure application
Intervention Description
The deep touch pressure will not be applied.
Primary Outcome Measure Information:
Title
Heart Rate Variability (HRV)
Description
A non-invasive technique to investigate the effect of mental stress of the autonomic nervous system control on heart rate.
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.
Title
Electrodermal Activity (EDA)
Description
A non-invasive technique to investigate the effect of mental stress of the sympathetic nervous system control on sweat gland of skin.
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
Title
Heart Rate Variability (HRV)
Description
A non-invasive technique to investigate the effect of mental stress of the autonomic nervous system control on heart rate.
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.
Title
Electrodermal Activity (EDA)
Description
A non-invasive technique to investigate the effect of mental stress of the sympathetic nervous system control on sweat gland of skin.
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.
Title
Heart Rate Variability (HRV)
Description
A non-invasive technique to investigate the effect of mental stress of the autonomic nervous system control on heart rate.
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.
Title
Electrodermal Activity (EDA)
Description
A non-invasive technique to investigate the effect of mental stress of the sympathetic nervous system control on sweat gland of skin.
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.
Secondary Outcome Measure Information:
Title
Dental Anxiety Scale (DAS)
Description
This questionnaire can range from 4 (not anxious at all) to 20 (extremely anxious).
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.
Title
Dental Anxiety Scale (DAS)
Description
This questionnaire can range from 4 (not anxious at all) to 20 (extremely anxious).
Time Frame
The averaged time of dental treatment is about 40-90 minutes.This questionnaire will be applied immediately after the dental treatment completion.
Title
Numeric State Anxiety Scale (NSAS)
Description
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.
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.
Title
Numeric State Anxiety Scale (NSAS)
Description
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.
Time Frame
The averaged time of dental treatment is about 40-90 minutes.This scale will be scored immediately after the dental treatment completion.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hsiang Yang, DDS
Phone
+886-2-2312345
Ext
70478
Email
dtdent90@yahoo.com.tw
First Name & Middle Initial & Last Name or Official Title & Degree
Hsin-Ming Chen, DDS, PhD
Phone
+886-2-3123456
Ext
67709
Email
hsinmingchen@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hsiagn Yang, DDS
Organizational Affiliation
Department of Dentistry, National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hsiang Yang, DDS
Phone
+886-2-3123456
Ext
70478
Email
dtdent90@yahoo.com.tw
First Name & Middle Initial & Last Name & Degree
Hsin-Ming Chen, DDS, PhD
Phone
+886-2-3123456
Ext
67709
Email
hsinmingchen@hotmail.com
First Name & Middle Initial & Last Name & Degree
Hsiang Yang, DDS

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is not a plan to make IPD available.

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Behavioral Support Techniques on Anxiety and Physical Reaction From Dental Treatment

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