Dental AnxietyNCT03819166
Behavioral Support Techniques on Anxiety and Physical Reaction From Dental Treatment
A study testing with deep touch pressure application and without deep touch pressure application in people with Dental Anxiety and Dental Diseases, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Anxiety, Dental Diseases, Dental Trauma
- What is being tested?
- with deep touch pressure application and without deep touch pressure application
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteTaiwan
- Study dates
- 11 Mar 2011to 30 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 75 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients who requiring tooth extraction were potentially selected to recruit.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100
Hsiang Yang, DDS, +886-2-3123456 ext. 70478, dtdent90@yahoo.com.tw
Hsin-Ming Chen, DDS, PhD, +886-2-3123456 ext. 67709, hsinmingchen@hotmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Dental Anxiety, Dental Diseases, Dental Trauma
- Being tested
- with deep touch pressure application, without deep touch pressure application
- Medical subject headings
- Stomatognathic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
with deep touch pressure applicationDevice
The deep touch pressure is applied by the weight loading devices, including but not limited to, weight blanket and weight vest.
without deep touch pressure applicationDevice
The deep touch pressure will not be applied.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | The participants recruited in the group will receive the input of deep touch pressure during their procedures of dental treatment. Receives: 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. Receives: Device: without deep touch pressure application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart Rate Variability (HRV)
A non-invasive technique to investigate the effect of mental stress of the autonomic nervous system control on heart rate.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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 can range from 4 (not anxious at all) to 20 (extremely anxious).
Measured: 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)
This questionnaire can range from 4 (not anxious at all) to 20 (extremely anxious).
Measured: 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 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.
Measured: 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)
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.
Measured: The averaged time of dental treatment is about 40-90 minutes.This scale will be scored immediately after the dental treatment completion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2019
- Study start11 Mar 2011
- Primary completion18 Jul 2013
- Study completion30 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental AnxietyStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hsiagn Yang, DDS, Principal investigator, Department of Dentistry, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03819166
- Sponsor's protocol ID
- 201012061RC
- Status last verified
- Jan 2021
- First submitted
- 14 Jan 2019
- Last updated
- 15 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Behavioral Support Techniques on Anxiety and Physical Reaction From Dental Treatment
- ClinicalTrials.gov ID
- NCT03819166
- Acronym / sponsor ID
- 201012061RC
- Conditions
- Dental Anxiety, Dental Diseases, Dental Trauma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 11 Mar 2011 (actual)
- Primary completion
- 18 Jul 2013 (actual)
- Study completion
- 30 Jan 2022 (estimated)
- First posted
- 28 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Device: with deep touch pressure applicationThe participants recruited in the group will receive the input of deep touch pressure during their procedures of dental treatment. |
| control group | Sham comparator | Device: without deep touch pressure applicationThe participants recruited in the group will not receive the input of deep touch pressure during their procedures of dental treatment. |
Who may qualify
- Ages
- 10 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who requiring tooth extraction were potentially selected to recruit.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| with deep touch pressure applicationThe deep touch pressure is applied by the weight loading devices, including but not limited to, weight blanket and weight vest. | Device | experimental group |
| without deep touch pressure applicationThe deep touch pressure will not be applied. | Device | control group |
Primary outcome
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.
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.
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.
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.
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.
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.
4 secondary outcomes
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.
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2021.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hsiagn Yang, DDS principal investigator
Department of Dentistry, National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing with deep touch pressure application and without deep touch pressure application in people with Dental Anxiety and Dental Diseases, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hsiang Yang, DDS (+886-2-2312345 ext. 70478, dtdent90@yahoo.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2021.