Behavioral Support Techniques on Anxiety and Physical Reaction From Dental Treatment

NCT03819166 | Unknown

• 1 other identifier: 201012061RC
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Anxiety; Dental Diseases; Dental Trauma

Outcome Measures

Primary Outcomes (6)

• Heart Rate Variability (HRV)

  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)

  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)

  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)

  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)

  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)

  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 Outcomes (4)

• 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.

• Dental Anxiety Scale (DAS)

  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)

  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)

  The averaged time of dental treatment is about 40-90 minutes.This scale will be scored immediately after the dental treatment completion.

Study Arms (2)

experimental group

EXPERIMENTAL

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

control group

SHAM COMPARATOR

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

Interventions

with deep touch pressure application DEVICE

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

experimental group

without deep touch pressure application DEVICE

The deep touch pressure will not be applied.

control group

Eligibility Criteria

• Age: 10 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who requiring tooth extraction were potentially selected to recruit.

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

MeSH Terms

Conditions

Stomatognathic Diseases

Study Officials

• Hsiagn Yang, DDS

  Department of Dentistry, National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hsiang Yang, DDS

CONTACT

+886-2-2312345; dtdent90@yahoo.com.tw

Hsin-Ming Chen, DDS, PhD

CONTACT

+886-2-3123456; hsinmingchen@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2019
• First Posted: January 28, 2019
• Study Start: March 11, 2011
• Primary Completion: July 18, 2013
• Study Completion: January 30, 2022
• Last Updated: January 15, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)